4aBetterBusiness
Provides Essentials of ISO 9001(2000) intranet/internet training software
for managers and employees, plus computer-based training in problem
prevention, root cause analysis / quality tools, and problem
identification and prevention (FMEA, failure mode and effects analysis).
Free online demos.
ABB
ABB Eutech offer a number of managed services to assist you in
achieving compliance with 21 CFR Part 11. For further details please
contact: ABB Eutech Ltd, Daresbury Park, Daresbury, Warrington,
Cheshire, WA4 4BT Tel: 01925 741111 - Fax: 01925 741212 - e-mail: contact@gb.abb.com
Accuva Technologies
Accuva Technologies provides telephony services, Phone Call recorders,
Hosted Interactive Voice Response (IVR), along with Audio and Web
conferencing systems. Our products are built for reliability and fit
within most budgets. Contact us by calling 877-480-7727 or email
jr@accuva.net
Acumen
Healthcare Solutions
Acumen’s core focus is “Streamlining Data Collection in Clinical
Trials.” Acumen’s FDA compliant TracIt2k™ EDC solution, affordably,
allows you to easily and quickly create your own electronic Case Report
Forms (eCRFs) containing “Data Validation Checks” and automatically
importing the data directly into any database or data management solution.
TrackIt2k can be used to enter data “On-line,” “Off-line” or a
combination of both depending on your sites needs and capabilities.
AditTech Consultants
AditTech Consultants is an professional services firm serving the
Biotechnology, Life Science, and Healthcare industries. AditTech provides
consulting to help Biotechnology and Life Sciences firms develop a
strategy to meet operational objectives while satisfying FDA and other
regulatory bodies.
Advanced
Control Services
Advanced Control Services Inc. is a company dedicated to provide control
solutions and engineering services to manufacturing companies. Our
specialty is control systems and manufacturing equipment. Our services include: PLC and SCADA design, programming and documentation, Control
Systems Design, Installation and Start-up Computer Validation throughout
all the project phases and Pharmaceutical Equipment Trouble-shooting and
Maintenance Systems Integration.
Advantage
Industrial Automation
Advantage Industrial Automation helps our customers: - Enhance business
processes and meet regulatory requirements - Minimize exposure to Part 11
enforcement action - Install PLC-based solutions in compliance with 21 CFR
Part 11 - Successfully implement batch execution and tracking, electronic
signatures and work instructions, and maintain electronic batch records
and expedite batch release
Aegis Analytical
Aegis' flagship product, Discoverant, is the only enterprise solution
offering a complete environment for data-intensive decision making to
achieve manufacturing quality compliance and global operating efficiency.
Reducing the number of lost batches, increasing predictability of outcomes
and allowing for easy APR assembly are just a few of the benefits
Discoverant provides to leading industry giants world-wide.
Agile Software
Agile Software provides collaborative Product Chain Management (PCM)
solutions for the medical device and medical equipment manufacturers.
Agile's PCM solutions include Product Collaboration, Product Sourcing and
Product Service & Improvement suites - solutions that deliver
significant bottom-line results by helping companies manage materials
costs, rapidly introduce products to meet market demand, and substantially
improve productivity and product quality, while maintaining control for
FDA and QA compliance. Agile's solutions are Part 11 compliant for e-
records and e- signatures with a proven validation methodology.
Agile
Technologies
Agile is a technology consulting firm specializing in creating
applications that automate pharmaceutical processes and have done so for
some of the largest pharmaceutical companies in the world. We are familiar
with the requirements of the pharmaceutical industry, operate under
appropriate methodologies to support validation efforts, and have
experience creating applications that are 21CFR Part 11 compliant. We have
developed a set of best practices with regard to Part 11 remediation and
have implemented innovative and cost effective strategies for achieving
compliance.
Aitken
Scientific
A-S Login is a software module which makes it simple to add 21 CFR Part 11
compliance to any of your own C++ or Visual Basic software applications.
It handles all aspects of login, including application version validation,
user rights handling, and application configuration parameters. The
compliant data is protected from unauthorized changes using encryption and
check summing techniques. A fully featured and validated administration
program allows central administration of all user and application
settings. Visit our web site for full details of this exciting product and
other compliant bespoke software systems developed by Aitken Scientific
Ltd.
Alpha Softech
we provide total software for forging industries, machining industries, tooling development industries. Our software modules are customer enquiry, cost estimation, machine hour rate calculation, generating quotation, purchasing, bill of material, production, machine maintenance, calibration, ppap, and apqp modules. We also under take development of custom built software
Amadeus
Amadeus develops and markets eQRP®, software solutions that will help you, no matter what is your industry, to manage and continuously improve your business performance with integrated management of your processes. You will then be able to comply to different standards and management frameworks, but also to manage competency and training.
Appian Analytics
Appian Analytics is an analytic service bureau that specializes in helping
clients use data to their fullest advantage. Our services include
statistical analysis, report automation, custom OLAP software development,
data warehousing, automated data processing, ETL, conversion, and database
mining.
Applied
Control Engineering
Applied Control Engineering (ACE) is an
independent control and information technology systems integrator
specializing in services related to 21 CFR Part 11. Our offerings include
gap analysis and remediation for existing legacy systems, as well as
specification development and implementation of new systems. All systems
are designed and implemented to ensure compliance with ER/ES regulations.
ACE provides test protocols for system IQ and OQ testing and can assist in
the execution of protocols. ACE is an integrator for all the major
HMI, PLC, and DCS hardware and software vendors.
Aranea IT
Aranea IT develops web applications which provides 100% compliance to
GxP (GLP, GCP and GMP) and fulfills the requirements stated by FDA's 21
CFR Part 11.
Arcadis
Arcadis is a global engineering firm serving 100+ countries. A
world-class, professionally registered group of engineers specifically
geared toward high-end System Integration and issues with 21CFR Part 11 is
located in Raleigh, NC USA, adjacent to Research Triangle Park. We pride
ourselves in a 100% acceptance rate of installed systems.
Argosy
Argosy develops innovative solutions using generalized process management
software. Our customized solutions streamline new drug R&D and ensure
compliance throughout the new drug life cycle. We specialize in solving
immediate challenges quickly through prototyping. Our solutions integrate
existing systems and provide an incremental, low-risk path towards an
end-to-end standards-based solution.
Art of Integration: ORBISM
Dublin based integration company providing robust solutions for keeping in
compliance with 21CFR Part11. Partnered with IBM, BEA and Microsoft
Approved.
AssurX
AssurX provides CATSweb, a 100% web-based, zero-client, 21 CFR Part 11
compliant Corrective Action Tacking System designed to manage problems and
issues from occurrence through disposition and corrective action.
Sophisticated security controls and time-stamped audit trails make CATSweb
fully compliant with FDA regulations governing electronic records and
electronic signatures. CATSweb is designed to be used in an intranet (LAN)
or Internet environment. AssurX also offers validation (IQ/OQ)
documentation as well as custom software validation services.
ATR Industrie-Elektronik
System integrator for automation and IT-solutions in various application
do-mains; client-specific realisation from planning to commissioning, with
ERP-linkage, support, service and training. System solutions for 21 CFR
Part 11 applications, attached to the existing hardware and software
environment, generally without the need for replacements or modifications
therein.
Automsoft
Automsoft is a leading global provider of data management software to
process industries. Our flagship product, RAPID, is specifically designed
to collect, analyze and report on time series and batch data collected
from from all data sources. RAPID-Pharma, the version of RAPID designed
specifically for biotech and pharmaceutical industries was the first data
management solution to facilitate compliance with 21 CFR Part 11; it is
installed in 6 of the global top 20 pharmaceutical companies worldwide.
RAPID-Pharma incorporates full audit trail, digital signature technology
including fingerprint recognition, traceability of all data and tracking
of alarms and events.
Barnett
International.
Barnett International provides specialized consulting and training
services to pharmaceutical, biotechnology and medical device companies
seeking expert guidance during all phases of the drug development process.
We offer expertise in such areas as Clinical process development and
improvement, project management, organizational assessment and design,
strategic outsourcing, regulatory systems and process consulting, quality
assurance, and systems validation services. Barnett understands the
challenges faced by both large and small companies in developing and
registering products in an increasingly complex and competitive global
market.
Base Information
Management Pvt Ltd
Base is a leading provider of Pharma Specific enterprise-wide business
solution-ITM, which meets the stringent requirements of the FDA,
including 21 CFR Part 11. ITM has been the preferred vendor for
Pharmaceutical manufactures in India & globally to meet the challenges
of GMP and FDA compliance
Bassilichi S.p.A.
Bassilichi is an IT Italian company and since 1998 it is supplier of the
EC for projects related to the implementation of SW solutions.As result
of the experience acquired in the EudraVigilance project (the EU system
installed at the EMEA for managing ICSR - reports on adverse reactions
to medicinal products) it developed ARES, a web based application
dedicated to the Pharmaceutical companies that permits to be compliant
with the EU Directives in the context of the Pharmacovigilance
life-cycle.
BBS&G
BBS&G has a track record of implementing
software in complex and challenging environments, providing Validation, Integration, Implementation,
Evaluation, Project Management, Security, Networking and Software
Development
services for mainframes, mini computers, PCs and Networks. We have the technical, managerial, compliance and business skills to
provide you with the techniques, processes and methods that
guarantee achievement of your corporate goals.
Beamex
Beamex has for more than 25 years specialized in developing and
manufacturing high quality calibration and maintenance hardware and
software for maintenance of processing instrumentation. Beamex's powerful
and versatile Calibration Management Software is based on regulations set
out by FDA (21CFRpart11). Beamex is a double ISO9001 certified company
with a top modern, accredited laboratory.
Bio Image Systems, Inc.
Bio Image Systems, Inc. is a sales and support company for Bio Image
software, including 21 CFR Part-11 Image Analysis Software. Bob Luton,
President and Chief Technology Officer, has 18 years experience developing
and supporting the Bio Image suite of products.
Bionetrix
BioNetrix develops software for centrally managing user authentication and
sign-on processes, enabling organizations to increase security, enhance
access convenience and reduce the costs associated with passwords and
identity management. The BioNetrix Authentication Suite provides the
centralized management necessary to deploy any combination of advanced
authentication technologies, and implement policy-based, Single Sign-On
access to client-server, legacy and Web-based applications.
Blue Mountain Quality Resources
With installations at nine of the top ten Fortune 500 pharmaceutical
companies, Calibration Manager has the Best in Class functionality for all
FDA regulated companies. The software combines powerful functionality with
a distributed architecture to create a robust software application.
Whether a company has one user or many concurrent users, an organization
can centralize data while allowing enterprise-level access.
Brigham & Associates
Brigham & Associates Inc. has been specializing in pharmaceutical and
medical device quality systems since 1991. We offer 21 CFR Part 11
compliant enterprise level software solutions for complaint handling,
corrective and preventive action (CAPA) and product recall management. Our
solutions are designed with multiple layers of access control,
multi-location issue numbering schemes, advanced dynamic reporting, and a
user-friendly interface, all in a 100% web-based, zero-client environment.
Brooks Software
Brooks Software is a worldwide leader in real-time applications for
enterprises with collaborative, complex manufacturing operations. Brooks
Software’s Real-Time eDHR allows medical device manufacturers to easily
convert their paper-based device history records into an electronic,
paperless solution that is based on the industry-proven reliability and
functionality of Brooks’ real-time applications.
Buildfolio
Buildfolio is a leading provider of enterprise and wireless software
solutions for property and asset management to the industrial and
commercial real estate markets. Buildfolio's solutions ensure
organizational compliance with regulatory requirements such as FDA 21
CFR 11 through stringent security and access controls, audit trails,
electronic signatures and comprehensive tracking capabilities.
Buoy5
Buoy5 was formed to help increase productivity for our clients with
software and services. After years of providing procurement and resource
management solutions, we've developed a core set of modules that are
highly configurable. With our b5iApprove product you'll still get a custom
solution, but we'll leverage our existing code for faster development and
reduced costs than if you had started completely from scratch.
Burntsand
Burntsand is a professional services firm with a long-standing track
record within the Pharmaceutical Industry. We offer both custom
architecture development and product integration. We are the leader in
content management, customer relationship management and enterprise portal
development. Burntsand is a publicly traded, profitable consultancy.
Within the Pharmaceutical space, we specialize in Clinical Trials
Management, Regulatory Compliance and Project Management.
Camstar
Manufacturing medical devices demands great attention to both process
detail and product tracking. With Camstar's Virtual Factory, manufacturers
can integrate live manufacturing information with multiple business
systems already in place for - Meeting FDA regulatory requirements
(21CFRpart11), Speeding time-to-market, and reducing liability.
Canongate Technology
Based in the central belt of Scotland, Canongate is a process automation
and instrumentation company providing PLC control systems and SCADA type
solutions based on widely available tools to achieve 21 CFR part 11
compliance. Canongate Technology Ltd, 36 INglis Green Rd., Edinburgh, EH14
2ER Tel: +44 (0) 131 455 7211 Fax: +44 (0) 131 455 7928
CAP Gemini Ernst & Young
CGEY understands compliance challenges, by leveraging our industry
knowledge & ability to manage complex programs; we developed an end-to-end
solution to assist our clients in not only achieving regulatory compliance
but also realizing its full benefits. Using our Service Centers,
Regulatory Compliance Centers & Accelerated Solutions Environment that
include methodologies and approaches to compliance, our proven capability
in all areas of the compliance effort equals compliance at a lower cost.
Carnegie
Technology Associates
Carnegie Technology Associates is a consultancy and software company
specializing in the analysis, design, implementation, validation, and
support of information systems for companies in the biotechnology and
pharmaceutical industries. Our Global Safety Surveillance database
management system provides global management and reporting of adverse
event data for drugs, devices, and vaccines.
CBE Technologies
CBE’s OneStop Support Solutions are your most dependable resource to keep
your system software and hardware up and running 24 x 7 – whether servers,
network, PCs or printers. Our Support Solutions focus on the health of
your systems. Our remote management infrastructure, onsite support
capabilities and national partner network deliver the support to meet your
critical business SLAs throughout the US.
ChemSW
ChemSW announced a new option for its CIS Chemical Inventory System®
that provides audit trail and electronic signature, for 21 CFR Part 11 compliance. The system incorporates multiple levels of security,
transaction logging and signature verification. Ideal for use in
pharmaceutical laboratory applications, the new security and audit trail
option allows the system administrator to determine which users are
authorized to make various kinds of changes, and enables accurate tracking
of all change sources.
Chrysalis Information Systems
Chrysalis provides offshore (Mumbai in India) validation, testing, and
verification service for 21 CFR PART 11 compliance. Chrysalis creates
relevant cost-effective & efficient solutions using imbibing & integrating
latest technologies in the context of the business needs and preferences
of its customers, thereby enabling its customers exploit Information
Technology.
ClinSource
ClinSource is the leading provider of integrated, web-based
IT solutions for the pharmaceutical, biotechnology and healthcare
industry. Our goal is to help improve clinical development by providing
and supporting a complete web-based IT suite of clinical research
applications, which consists of Clinical Trial Management software (TrialXS
/ TMS), Clinical Research form Designer (TrialXS / CRF), Electronic Data
Capture (TrialXS / EDC), Data Management (TrialXS / DMS), Online
Randomization (TrialXS / RDM).
Clockware
A leading provider of web-based time tracking, and timesheet software.
Coast Software Solutions
Coast Software Solutions, Inc. is a computer software development company
specializing in database applications and utilities. Recently, Coast
Software Solutions, Inc. released Equipment Maintenance Tracker, a
software product designed to simplify the management of equipment
maintenance. This software contains the built-in technical controls of a
compliant system. To read more about Equipment Maintenance Tracker go to
our Web site and click on products.
Cobent
Cascade Pro, Cobent's industry leading LCMS, has been designed for
regulated industries. With full audit trail capability and the
integration of compliant Electronic Signatures, Cascade Pro is the
obvious choice for organizations with regulatory training requirements.
Cascade Pro meets the stringent security and auditing requirements of 40
CFR Part 3, 21CFR Part 11, DoD 5015.2-STD and the Uniform Electronic
Transactions Act (UETA) making it one of the most compliant systems in
the world.
Cognizant
Technology Solutions
Cognizant Technology Solutions (Cognizant) is a leading e-business and
applications outsourcer, providing software development and application
management services for Fortune 1000 companies. Cognizant has worked on
21CFR11-compliant systems for a leading web based clinical trial
management software vendor and have also built a compliance tracking
system for a leading biotech firm in the US. This combination positions
Cognizant ideally to partner pharmaceutical and biotech companies in
making their systems 21CFR11 compliant.
Compliance Software
Solutions
Compliance
Software Solutions Corp. is a provider of regulatory and quality assurance
software and services for manufacturers in the pharmaceutical,
biotechnology, and medical device industries. The software-based tools
enable the manufacturer to effectively monitor, control, and if necessary
correct essential areas of operation
CompuPharma
CompuPharma provides e-Learning training solutions to the Pharmaceutical,
Biotechnology, Healthcare, Bulk/API and other Regulated Industries that
improve employee performance, regulatory compliance and operational
effectiveness.
Computer
Associates
Computer Associates (CA) provides market-leading, industrial-strength
software change and configuration management solutions to support your
entire enterprise. Our solutions run in a wide range of operating
environments from mainframe to PC and UNIX, and support various
development environments, whether homogenous, client/server or distributed
across platforms. AllFusion Endevor and AllFusion Harvest CM can meet FDA
regulations on required functions for approval, audit trail, and time
stamping.
Computer Task Group (CTG)
CTG
offers global validation services to assess and remediate systems to
attain compliance. CTG deploys professional teams to assist Life Sciences
companies in achieving compliance in: Research and Development, Clinical
Trials, Manufacturing, Marketing and Sales. Our focused teams are
knowledeable in lifecycle software development, GxP validation, 21 CFR 11
and the management of validation documents. Please contact Ed Moroney at
(800)982-3445 or ed.moroney@ctg.com.
Continental Resources Inc.
Continental Resources (CRI) is a systems and network integrator in
business for over forty years. CRI has created a practice to help
companies manage business risk. This practice, available from any of our 6
locations, helps you address IT related regulations and compliancy issues
revolving around electronic content. With the support of our technology
partners, 21CFR part11 is just one of the many regulations we help you
tackle. Please contact us at 1-800-937-4688 option 2
Continuum
Systems
Continuum Systems is a total IT services provider.Our coordination center
is centrally located in Gurgaon, India – close to Delhi. From there we
communicate, coordinate, and manage all our projects globally. We provide
our services in U.S.A. and European Markets.
In addition we offer comprehensive Online Chat services given to clients
on a 24 hour basis.
Controllink
Controllink, a CSIA Best Practices and Benchmarks System Integrator, can
help lead you to a paperless 21 CFR Part 11 process. 1650 Cambridge Drive
Elgin IL.
Coolblue
Calibration Manager's electronic signature functionality is designed
specifically to help you meet the record-keeping requirements of 21CFR
Part 11. You can approve records more efficiently, under a secure system,
and without any paper. Features include a time-stamped audit trail,
password expiration, mandatory electronic signature, and more.
Correlate Technologies Inc.
By applying Correlate’s visual document management capability with leading collaborative and portal technologies, Correlate offers a life science customer the ability to track, store and certify documents in the product research and development process, as well as add the value of collaborative document access and review which allows for decreased cycle times and increased productivity and competitiveness while maintaining compliancy with the FDA under 21 CFR Part 11.
Cosyn
Software
Solve the 21 CFR Article 11 challenge of capturing changes to key data .Cosyn
Audit Trail/400 software will allow you to add electronic audit trails to
any IBM AS/400 or iSeries computer system, without having to modify any
existing programs. Audit Trail/400 creates audit trails in minutes - not
days - without the need for expensive programming. Audit Trail/400 tracks
all changes regardless of origin - business application, interactive SQLs,
or any other database utility. Simply define the files and fields that you
want to monitor and Audit Trail/400 does the rest. It identifies the user,
date, time and work-station where the change was generated, and what the
contents were before. Full inquiry, reporting and database management
functions are included.
Covex
COVEX, LLC is dedicated to providing superior system integration services
towards the design, engineering and installation of automation platforms
for the pharmaceutical, biotechnology, specialty gas, and chemical
industries. Our goal is to provide robust automation platforms in
accordance with the client’s requirements on time and within budget. We
are ideally positioned to provide 21 CFR Part 11 technical and procedural
remediation services for your system platforms to attain full compliance.
CryoTrack
CryoTrack provides inventory management system for cellular, molecular,
biochemistry, IVF and clinical labs. CryoTrack products are ideal for
all storage containers. Users benefit from numerous features such as
import/export data, custom defined fields, frequently used fields, cell
types, notes, transaction logs, edit history, tracking deleted records,
graphical view, assays, protocols, reagents, printing labels, sending
and retrieving messages, extensive search options and much more.
CSOLS plc
CSols is a premier global product and services company who dramatically
increases the productivity and efficiency of quality assurance and R&D
laboratories through Laboratory System Integration. In an increasingly
competitive business environment, companies are faced with the challenge
of selecting, operating, and integrating a vast array of disparate
Laboratory Information systems and related data while providing high
quality and cost effective analytical information to their customers.
Daffodil Solutions
Daffodil Solutions is an Indian offshore software solutions and
outsourcing Services Company, offering quality & affordable IT
solutions across the globe. Our team of experts adapts to your needs and
provides innovative IT solutions which can be deployed in the real
business environment.
Daon
Daon is a biometric identity management company offering a unique and
integrated approach to meeting the challenges of enterprise security. Daon
protects an individual's privacy while ensuring non-repudiation and
operational and security risk efficiencies. Daon delivers a highly
scalable and robust technology infrastructure to organizations in the
Financial Services Sector, the Government & Security Sector, the
Travel & Transport Sector and the Pharmaceutical & Life Sciences
Sector.
DataCore Technology
DataCore Technology specializes in implementing Engineering Data
Management (EDM) solutions for pharmaceutical companies. We design,
configure, implement, and integrate high-quality EDM solutions to help
our customers improve time to market, reduce asset maintenance costs,
and comply with government regulations such as FDA 21 CFR Part 11.
DataCore operates with integrity, provides quality products and
services, and is committed to excellence.
Data
Mirror
DataMirror provides real-time data integration software that helps
companies ensure cost-effective compliance with FDA Regulation 21-CFR Part
11. LiveAudit™ for DataMirror Transformation Server enables
FDA-regulated companies to create real-time audit trails that preserve
historical information.
Database Design Solutions
Database Design Solutions is a database-reengineering firm focused on the
revitalization of corporate data. With a niche specialty in metadata, we
are perhaps the only consulting firm that considers life beyond the
immediate functional need when combining and coordinating clinical,
manufacturing, marketing, and sales data. In business since 1989, we have
earned a solid reputation in the life sciences industry, having worked for
most pharmaceutical companies.
Datastream
Datastream is the global leader of technology-based, Web-architected
solutions for asset lifecycle management. With electronic signatures, a
revision control network, security controls, and audit trail capabilities,
Datastream software offers the functionality to meet the individual needs
of companies dealing with 21 CFR 11 concerns while helping them reduce IT
costs.
Datasweep
Datasweep is the leader in Operations Performance Management solutions for
manufacturers. Our solutions uniquely enable global manufacturers to
collect, aggregate, analyze and act on product and operational data from
the entire product lifecycle and supply chain, improving process
efficiencies and product quality, reducing product lifecycle costs and
ensuring regulatory compliance (cGMP, 21 CFR Part 11 and Part 820).
DATATRAK International
DATATRAK International, Inc. is a worldwide ASP for the EDC industry. The
Company provides a suite of software products supporting the use of
DATATRAK EDC and related services to the pharmaceutical, biotechnology,
and medical device industries. DATATRAK EDC can be deployed worldwide in
either a distributed platform using laptop computers or in a centralized
environment using the Internet.
DB Information Systems
david.trueman@dbis.biz
DB Information Systems provide traceability, HACCP and GMP validation
systems for the food and other industries. Specialist products cover the
agri feed and grains industry and white goods test data systems.
Deadline
Solutions
Deadline
Solutions, Inc. (DSI) delivers high quality Client/Server and Internet
enabled applications that will provide 21 CFR Part 11 Compliance for the
Food and Drug Industries. DSI will provide its customers with both
"Process" and "Vendor OEM" software in order to ensure
compliance within the industry. DSI's Electronic Documentation System
(EDS)
is a Rapid Application Development tool that is used by our staff to
quickly create a 'Manufacturing/Production Process' or map functionality
to a given piece of process equipment. Any given piece of data can then be
selected as passive or required to have an electronic signature to ensure
compliance.
DistinctHorizon Corporation
DistinctHorizon helps companies in the pharmaceutical and life sciences
industry to better manage information, regulatory compliance, improve
the user experience, and lower costs by automating data and document
related tasks. Its product suite includes Document and Form Management,
Clinical Dashboard, Clinical Data Capture and Molecule Data Warehousing
solutions.
DK Computer Systems Ltd
DK Computer Systems have produced a unique solution which provides
inline signatures, documentation and audit trailing for Rockwell's
popular RSView32 SCADA package.
Users can edit documents and reconfigure signature requirements from the
run time system.
Documents are HTML formatted and can be regulatory notices, cautions,
checklists, technical data or any thing else.
This solution is used both in the food and pharmaceutical industries.
DKSystems
DKSystems provides LMS software and services targeted to corporate and
government organizations. Throughout its 15-year history as a developer of
market-proven solutions, DKSystems has established itself as a leader in
the training marketplace. Its LMS solution helps companies quickly and
cost-effectively implement learning initiatives to keep workforce skill
sets current. DKSystems helps customers such as Bayer, Pfizer, Pharmacia
and Amgen stay compliant with the 21 CFR Part 11 requirements.
Doxis
Doxis lets GMP-compliant manufacturers migrate their collaborative
document execution processes to the Internet or secure Extranets,
completely replacing controlled paper forms systems and processes with
Part 11-compliant electronic processes and electronic forms and data
collection. A wireless interface extends the application to mobile workers
in laboratories and manufacturing plants. It can be used for
manufacturing-related document processes, such as batch record collection
and laboratory data sheets, as well as supply chain document processes,
such as materials qualification and supplier surveillance.
DUII
DUII develops and markets its products and services of laboratory
information management system (LIMS), 21CFR11-aware computational
infrastructure, and Standard Operating Procedure (SOP)-driven networks.
These satisfy the requirements of 21CFR11 by authority check, operational
system check, device check, SOP, electronic signature and closed systems.
DUII creates tools to enhance communication and to enforce compliance.
Dynamic Systems Solutions,
Inc.
DSS’ Auditron400 is a comprehensive data auditing tool designed for the
IBM iSeries (AS400). It provides the tools needed to facilitate the Part
11, electronic record keeping regulation compliance. Auditron400's data
auditing tools enable users to select files'fields for creation of audit
trails through the entire life of a record including the creation,
modification and deletion of a data element.
e-manufacturing solutions
We are a India based system integrators providing solutions in MES (
mnufacturing Enterprise Solutions ) area. Our main focus is providing
systems for 21 CFR 11 compliance. Our expertise covers all levels of
enterprise systems right from sensors ( level 0 ) to ERP systems ( level
4 ) We can handle any kind of end to end integration project.
Being India based company we can provide solutions in affordable cost
and superior quality.
Eagle
Technology
Eagle Technology, Inc. is one of the top-ranked developers of
facility/asset management software. With electronic signature work order
approvals, user/group rights security features, and comprehensive audit
trail capabilities for electronic records, Eagle systems are fully
equipped to accommodate companies subject to 21 CFR Part 11. With an Eagle
system in your maintenance/facilities department, you won't just handle 21
CFR Part 11, you'll also improve equipment reliability and reduce
maintenance.
ECHO OSIsoft
Store and document data with electronic signatures and audit trails. ECHO
software enables you to create time-series data archives with FDA
compliance. ECHO (‘Embedded Component Historian Object’) is a database to
create ‘data historians’ that comply with CFR 21 Part 11 for storing
time-stamped values. ECHO—written for OEM applications and
instrumentation—can be used alone or with other databases. It stores
250,000+ values per second and each historian can handle a million
datastreams.
Eedo Knowledgeware Corporation
Eedo is the leading provider of business solutions and software tools
enabling organizations to transform knowledge into productivity. Eedo
has helped the world’s most successful organizations implement practical
knowledge management strategies in order to maximize performance. Eedo
offers powerful tools built on six functional pillars: Dynamic Delivery,
Learning Content Management, Rapid Authoring, Assessment, Knowledge
Sharing and Performance Support.
ELAN SOFTWARE SYSTEMS
ELAN Software Systems is an international company with based in
Princeton, NJ and in Toulouse, Europe. Elan Software edits a FDA and
21CFR part 11 compliant Manufacturing Execution systems, XFP,
specifically designed for regulated industries. XFP runs on more than
100 pharmaceutical, fine chemical, cosmetic, and biotechnological sites,
including 7 of the 10 first global laboratories.
Endress
+ Hauser
The Memo-Graph S "Safety Data Manager" is a compact and powerful
solution in safety relevant applications. It conforms with 21 CFR Part 11
by securely recording processed data. By using Audit trails, sequences can
be verified. It plots signals, monitors alarm limit points, analyses
measurement points, stores data internally and archives on ATA flash
memory cards in a coded format. The standard E+H ReadWin® 2000 PC
software package is used for set-up, visualization and archiving of
recorded data.
Enterprise 21
Developer of enterprise software solutions for small to medium size
firms. System is operates on all major databases and server. Source code
is included with all sales.
Entrinsik
Entrinsik HCM, the GxP Edition provides a seamless framework for
simplifying the tasks of SOP-driven training and knowledge requirements
for the pharmaceutical and chemical processing industries. Entrinsik's GxP
Edition provides the robust learning management and employee development
and includes an enhanced audit trail, a competency-based framework for
job-specific learning needs, and an employee-self-service mode.
eOriginal
The eOriginal SmartSignTM
application allows pharmaceutical companies to completely automate the FDA
submission process by replacing "blue ink" signatures with electronic
authentication and approval technology that satisfies the requirements of
21 CFR Part 11. The product includes a comprehensive auditing system that
allows pharmaceutical companies to verify who signed a document, when it
was approved, and record the details of every event that occurs during the
document approval process.
ePlains
ePlains is a Microsoft Certified Business Solutions Center that provides
software and consulting services to midsize companies, including the
Microsoft ERP offerings and Microsoft CRM. ePlains Life Sciences software
extends Microsoft Great Plains to provide enterprise-wide business systems
which meet the requirements of companies that must adhere to the stringent
requirements of the FDA, including 21 CFR Part 11.
Essel software & services Ltd
"Essel Software & Services Ltd., Hyderabad, India provides quality
Software Development Services, Software outsourcing services, E-Commerce
Solutions, Web design & Development, Solutions for Accounting,
Manufacturing, Trading, Chitfund etc. It-Enabled services, Chit fund
software, SEO Services
ETQ
The only out-of-the-box intranet/internet based Quality system that can be
customized (forms and workflows) by a web browser, without programming.
Key modules include; Document Control, CAR/PAR, Audits, Training, APQP and
more. Our Software's ability enables us to provide audit trail and
electronic signature for 21 CFR Part 11 compliance.
Eye On Time
EyeOnTime is a web based timesheet and project management system for all
consultants and businesses which bill hourly or on a project basis.
ezGMP
For years the industry has struggled with the use of Excel for QA/QC and
cGMP activities. Not because Excel did not work, but lack of compliance
with Part 11 and exposure to 483's on protection, security, and data
integrity. ezGMP has created technical controls to make EXCEL compliant
with 21 CFR Part 11. Audit trails, secure login, and electronic signatures
are built into our product, a secure shell around Excel. Templates
containing formulas that you currently use can be handled by ezGMP.
Facility Monitoring
Systems Limited
Supplier of 21 CFR Part 11 compliant particulate environmental monitoring
software, particle counters, and associated equipment.
FasTrak SoftWorks, Inc.
FasTrak SoftWorks, Inc is a leading provider of industrial automation software for PLC programming and SCADA. Software products are designed to comply with the 21 CFR Part 11 regulations. Supported PLC vendors include Siemens, Modicon, Allen-Bradley, and Square D.
FBO
Systems
FBO Systems is a leading provider of EAM software and services that enable
companies to lower maintenance cost while increasing equipment
reliability. FBOS’ MLS®
provides full security against record tampering at the application and
database level, including strict controls on electronic signatures and
record revision audit trails to meet FDA and FSEP requirements. FDA
regulations and guidelines need not be an ordeal provided you have a
knowledgeable software and services partner.
FileOn
More than just a document manager, this server based solution provides
users with a full set of features including, Distributed Document
Upload, Server Based File Management System, PDF Splitter Utility, Audit
Trail, Meta Tags, Viewing (Tiff to PDF auto-converter) and Security.
Freeborders, Limited
A leading provider of product life cycle management software. Freeborders
product life cycle management software combines design, development,
quality management and logistics applications with consulting services to
optimize the profits of buyers and sellers in the global retail supply
chain. These solutions are used by over 350 customers in 26 countries.
Frontier
Technology
Frontier Technology, Inc (Frontier) founder and many of its founding
employees got started in the Life Science industry working on both
scientific applications (e.g, LIMS, Beckman Coulter, LifeSeq,...) as well
as business applications (e.g. Clinical Manufacturing, SAP, Peoplesoft,
Vantive...). Frontier's IT consultants have a unique understanding of the
issues confronting the pharmaceutical and Biotechnology industry, the
participants and the players. Our consultants also have the kind of deep
understanding of the issues confronting the Life Science industry that only
comes with years of direct experience.
Full
Spectrum software
Full Spectrum Software offers complete software testing and development
services. Our development expertise ranges from implementation of
technical analysis applications and device drivers, to business,
scientific and educational software. We also boast extensive
cross-platform expertise and have a successful track record of porting
applications to and from both Windows and Macintosh.
G
A Sullivan
G.A. Sullivan is an award winning enterprise solution development company
with 20 years of successful business solution development. Our Healthcare
practice allows us to focus on the clinical, business and technical
aspects of our clients’ goals. We have proven success in HIPPA
compliance engagements and pharmaceutical solutions. We believe that many
of the solutions needed to meet Federal regulations will be built rather
than bought. Our clients trust us to deliver successful solutions.
Generation21 Learning Systems
Knowledge management and e-learning software, training systems and
solutions. Knowledge and learning management tools for employee training,
classroom based education and online information.
Gini Networks, LLC
Gini Networks, LLC is an on-site service provider. We provide
comprehensive support in technology deployment and field maintenance
services. We would like to become an onsite service provider for your
clients in the New York city and tri-state areas
Gradkell Systems, Inc.
Gradkell pioneered electronic signatures in 1991. Since then, Gradkell has
become the premier electronic signature provider for the Department of
Defense and Department of State. Gradkell clients have received letters
from the General Accounting Office (GAO) sanctioning their electronic
signature solution as legally binding. Gradkell provides a "bolt-on"
product called "DBsign" to PKI enable legacy applications. This product
provides authentication, data integrity and non-repudiation.
Toll Free phone is: 1-866-GRADKELL
Harrington
Group
For more than a decade the Harrington Group has been the leading provider
of quality solutions for your desktop, network and internet environments.
caWeb, the enterprise Issue and Action Manager for Corporate Action,
provides a zero-client web-based solution with a 21 CFR Part 11 compliant
process to meet the needs of FDA regulated industries. It is an
exceptional tool for corrective action, customer care, and Issue and
Action Management. Its secure design delivers a controlled, secure and
fully auditable path for electronic records management which meets the
concerns for electronic signatures, password management and event logging
within a user-friendly process.
HCL
Technologies
HCL Technologies has carved a distinct position for itself as an offshore IT services company for Fortune 1000 companies. The company is now
expanding its focus to offer its services to pharmaceutical and
biotech companies in the areas of 21CFR11 compliance, new product
development, maintenance, enhancement, customization, testing,
building interfaces , help desk and porting to various platforms.
High Tech Services
HTS is a systems integrator specializing in industrial, laboratory, and
process automation. Our high quality systems integrate, control and
monitor your business. Our website has more than 200 pages and 2,000 links
in 50 categories packed with tutorials, examples, source code, links,
manufacturers, books, tips & tricks, message boards and other information
about production & laboratory automation.
HMS Software
TimeControl is a project-oriented timesheet system designed for
enterprise-wide use. The system is designed to integrate directly to your
scheduling software and to corporate systems such as Finance and HR
providing key tracking of where labor time is being spent
HunterStone Inc
HunterStone has been focused on the e-learning market for the last 2
years and launched the THESIS product line a year ago. THESIS provides
easy to use and cost-effective content authoring to help organisations
reduce and control overall training and learning costs.
Download and try THESIS free of charge
iBASEt
Solumina is a paperless software solution for Operations Process
Management covering process authoring, execution, change control, &
quality assurance. Solumina provides online work instructions with all the
required information at the fingertips of the operator including drawings,
specs, images, video, parts, tools, & data collection. Solumina gives you
complete as-designed, as-built, & as-maintained records. Solumina meets
the requirements of the FAA & FDA regulatory agencies.
IBS
Offers enterprise-wide quality management and shop floor control software
solutions for companies achieving/maintaining compliance to ISO
9000/14000, and 21 CFR Part 11. The QSI System for FDA Document Control
satisfies the requirements of Part 11 by providing all the templates and
examples needed to complete a well-structured Quality Manual and enable
the creation of Procedures, Work Instructions, Specifications, Quality
Plans and Process Description documents. IBS is ISO 9001 registered.
IconMedialab
IconMedialab is a world leader in developing new business opportunities
and e-Business solutions for our clients - across all Internet platforms
and devices. Here, we understand the importance of helping our
pharmaceutical clients streamline and improve the development process,
with a particular emphasis on security audits covering 21 CFR Part 11
compliance and implementations of PKI systems. Our expertise stretches
from research and development to sales, e-Detailing and marketing.
Impov Technology
Improv's Cirquet Solution Suite enables life science companies to take
advantage of and better utilize existing technology investments. Cirquet
allows companies to rapidly and cost effectively create scalable,
decentralized applications which can run anytime, anywhere on the network
providing built-in, scalability, resiliency and interoperability.
Cirquet's lightweight integration architecture gives the flexibility to
deliver robust solutions without the reliance of a central server.
Indus
InSite
Indus InSite is a leading web-based asset and work management solution
designed to address maintenance, repair, inspection, calibration, and
other business processes that affect product quality or safety. With
InSite, Healthcare and Pharmaceutical companies get a solution that is
easy to use, feature-rich, highly configurable, and adaptable to any
requirements they might have, including helping them comply with 21 CFR
11. With Indus InSite, there are no upfront capital costs, no software
licenses and no hardware to buy.
Industrial
Controls
Industrial Controls is a full service distributor of industrial automation
and solutions for 21CFR Part11 specializing in bringing existing control
system into compliance. Over 25 years experience. Covering the Northeast,
Industrial Controls backs a complete inventory of the industry's finest
products from leading manufactures, offering an extensive range of
services including consulting and technical training.
Industrial Design &
Construction Inc. (IDC)
IDC is a broadly diversified supplier of facility planning, design,
construction, and ongoing support services for process-intensive
technology industries. We offer total solutions to help give
world-class manufacturers a competitive edge. Since our founding, IDC has
stayed focused on our clients’ needs, developing both an extensive
knowledge of complex buildings and systems, and leadership in constantly
advancing manufacturing process technologies.
Infermed
InferMed is a leading software & services supplier to the healthcare
industry. InferMed has a powerful decision support technology with which
it builds applications such as its EDC system MACRO. MACRO’s interactive
tools for remote study definition, on-line and off-line remote data entry
and remote study monitoring reduce set-up time and improve time to
database closure. MACRO is the only independent EDC system that is fully
integrated with Oracle®
Clinical.
Infomanagement Services Pvt Ltd
Website designing, website development, search engine optimization,
software development, data processing, hardware solutions offered by
Infomanagement Services Pvt. Ltd. Website designing, website
development, search engine optimization from IMS India
Infomatics
Consulting Group
Infomatics Consulting Group (ICG) provides technology strategy and
technology solutions in Phama, covigilance and World Wide Safety. Solutions
include data warehousing and Decision support architectures for Regulatory
Adverse Events Monitoring. ICG's Multidimensional analysis and heuristic
information discovery architectures help Epidemiologists and Safety groups
analyze safety data to develop signal scoring and other pattern
recognition algorithms.
Infor Global Solutions
Infor provides vertical specific, enterprise-wide business solutions to
select manufacturing and distribution industries worldwide and delivers
best-in-class products that address the essential challenges its
customers face in areas such as supply chain planning, relationship
management, demand management, ERP, warehouse management,
marketing-driven distribution, and business intelligence. Infor has 30
locations worldwide and its solutions are used by 13,000 customers in
over 45 countries.
Informetric
Biosystems
Informetric Biosystems provides electronic batch reporting without
programming to worldwide process industries. InfoBatch™
enables manufacturing personnel to easily create comprehensive production
and exception reports through intuitive desktop applications.
Infosys Technologies Limited
Infosys, a world leader in consulting and information technology services,
helps Life Science Organizations (LSOs) leverage information technology to
drive productivity across their business processes. Infosys partners with
Global 2000 companies to provide business consulting, systems integration,
application development and product engineering services. Infosys has over
two decades of experience in the software services industry, has a global
footprint, and a workforce of 15,000+ consultants.
Innovatum
Innovatum, Inc. as consultants to some of America's most prominent
pharmaceutical and food manufacturers, has been immersed in validated
systems and protocols responding to regulatory requirements. Utilizing
this experience, we have created comprehensive software to handle FDA's 21
CFR Part 11 requirements for any AS/400 application. DataThread * has been
written specifically for Part 11, and is not an old data replication or
security package, patched to meet some of the regulatory needs. It can be
implemented in a few minutes for each file and does not require any
modification to the application programs.
Industrial
Technology Systems
Industrial Technology Systems Limited (ITS) is a leading edge customer
focused independent solution provider offering Real Time IT and Industrial
Control Solutions across Process and Manufacturing Industries. ITS
provides expertise in the following areas: Business Improvement Systems,
Validation Services, Batch Control Systems, Process Control Systems, Line Optimization
and Vision Inspection Systems and Manpower Services and Support. ITS has
performed many projects to bring existing systems up to the new 21 CFR part
11 standards and provided other new compliant systems too.
Intralearn Software
IntraLearn Software Corporation is the leading provider of scalable
e-Learning applications with more than 500 corporations, academic
institutions and associations worldwide using our platform. We provide an
affordable enterprise-class, field-configurable software application that
makes it easy to create, deliver and measure interactive learning over the
web.
Infrasafe
Infrasafe, Inc. is a security and data systems integration company that
provides systems for visitor management, access control, intrusion
detection, CCTV, surveillance, and biometrics. Infrasafe has a team of
project and program managers, vulnerability assessment and design experts,
and development staff that works with corporations and government
institutions to ensure security best practices work for your organization.
Integrated
Performance Systems
Integrated Performance Systems Inc. (IPS) is a recognized leader in
eLearning, Learning Management, and Performance Management Systems. The
iPerform™ Performance Management System helps companies hire, train, and
retain their most valuable assets -- their people. Regulatory
requirements, documents, certifications, and mandatory training can be
easily managed, tracked, and reported on.
Invensys plc
Invensys products, brands and services specifically address operational
challenges faced by the pharmaceutical industry today, including 21 CFR
Part 11 compliance features and services, unit cost accounting,
by-products accounting, and lot traceability. Name brands include Protean,
Prism, Wonderware, Foxboro, Eurotherm, APV, and Invensys Validation
Technologies.
ISA
Automation
ISA Automation has developed a unique method of identification using
fingerprint biometrics. The Only U is an identification API that will
easily integrate in any VB compliant software’s. It can be used for
implementing "On-click" security policies or logging users to
their activities. We believe this product will help software vendors and
integrators in building better conformity to the 21CFR part 11.
ISD Technology Group
Since 1982, ISD Technology Group (ISD) has been the only provider of
FDA-compliant enterprise wide solutions that guarantee zero-defect in
product labeling and packaging. ISD's clients include Zimmer, Pfizer,
Implex, Hollister, Baxter, Watson Pharmaceuticals and many others.
ISO9
ISO9, a Vintara brand, is the leading provider of fully automated,
Web-based enterprise quality management solutions and services. Offering
the unique tools to help you reach compliance with industry-specific
requirements, create standard operating procedures and set the path for
continual improvement, ISO9 delivers efficient and cost-effective
solutions to 21 CFR Part 11 or the medical device-specific ISO 13845.
ISOtrain
ISOtrain Training Management Solution is a powerful compliance driven,
quality based training tracking system. ISOtrain allows you to manage
employee training records on your global network. With a click of a
button, you can notify employees of scheduled training, e-mail a report to
management, review employee qualifications, or retrieve a course outline.
ISOtrain runs on multiple desktop platforms, network operating systems and
databases. Validation is made easy with a comprehensive validation
package.
JBL Systems
JBL Systems provides powerful software for Gage, Tool and Asset
Management with full Audit Trail Support, Electronic Signatures, User
Name and Password protection that follows FDA 21 CFR Part 11 guidelines.
Validation Documentation is available to test data in your environment.
Enterprise version allows multiple locations in one database, while
maintaining flexibility, security, traceability, & audit recording for
each user. Share templates, historical data, record transfer, reports
and more.
JD
Edwards
With our full range of integrated 21CFR11-compliant J.D. Edwards solutions
for the Life Sciences industry, you are able to realize lasting
improvement throughout your enterprise. Our business software and
consulting services can help you run your business more efficiently to
help grow your profits.
Journyx, Inc.
Free Web Timesheets. Automate Project Management, Billing & Payroll.
Track Time, Expenses & Mileage. Free 10 user license and Free Buyer's
Guide. Download Now!
Knowledgelinx.
Knowledgelinx™ offers award-winning e-learning solutions, including
infrastructure, custom content development and implementation services.
The flagship product, ROCKET KM brings together a unique combination of
knowledge management, and performance support tools that connect
employees, partners and suppliers with the knowledge they need to perform through a user-friendly, fully Web-based system.
Krell
Software
Krell Software produces OmniAudit, an add-on database auditing system for
Microsoft SQL Server. OmniAudit easily installs into any SQL Server
7.0/2000 database and records changes made from any source or application.
For more details, please visit our website or email info@krell-software.com
Lablite
LabLite LLC produces a powerful LIMS with innovative features in a simple
and clean graphical interface. LabLite is operator designed to suit your
preferences. Written in Visual Basic with MS SQL Server or MS Access
back-ends. Validation and pre audit services rendered by ScienceOps the
leader for all compliance solutions.
Labware
LabWare Inc. has been an established leader in supplying Laboratory
Information Management Systems and instrument integration software to
companies in diverse industries worldwide since 1988. LabWare's successful
validation record and compliance to 21 CFR Part 11 guidelines are some of
the reasons why many of the world's pharmaceutical companies have
standardized on LabWare LIMS.
Learnwright
LEARNWRIGHT is an e-learning company that develops and markets engaging,
interactive, high-value training solutions on a business-to-business basis
to the pharmaceutical/healthcare industry. The company’s products
uniquely combine training, testing, and individual performance tracking
with a web-based delivery strategy, enabling users to acquire skills and
demonstrate compliance on the job and off …anytime…anywhere.
Lilly Software; now
Infor Global Solutions
Lilly Software Associates, Inc. (LSA), recently acquired on October 20,
2004, by Infor Global Solutions, provides a complete line of enterprise
and supply chain management solutions for manufacturers and
distributors. With its easy-to-use graphical nature, the VISUAL suite of
products helps companies capture accurate, real-time data about their
business processes using Enterprise Resource Planning, Advanced Planning
and Scheduling, Manufacturing Execution System, Quality Management,
Customer Relationship Management, E-Business Relationship Management, and
Warehouse Management System capabilities.
Live Oak Technologies
Our quality suite is designed to help improve, manage, and streamline quality control procedures. All software is 100% web based with a single user management system. The goals of our quality suite are to reduce inefficiencies in quality tracking procedures, reduce product defects, provide total visibility into quality management, improve customer and supplier relationship, and to enhance quality collaboration.
LockwoodTech
LockwoodTech provides a wide variety of software solutions for the
Microsoft Developer including a large suite of SQL Server Products.
LockwoodTech offers solutions for database auditing, code generation, VB
error handling, database scripting and more.
LogiLab- Agaram
Agaram is a Laboratory Informatics and Analytical Instrumentation
company based in Chennai India. We have partnered with companies like
STARLIMS USA, Scientific Software USA and specialises in providing
Laboratory Information Management Systems (STARLIMS),
Instrument-Interfacing solutions (LogiLAB), Chromatography Data Systems
(EZChrom), Enterprise Content Management Systems (Open LAB), Chemoffice
for Drug Research.
LORENZ Life Sciences Group
LORENZ provides document assembly & publishing solutions (IND/eIND, CTD/eCTD)
for regulated environments within Life Sciences. It is also the
developer of the worlds leading submission management system,
docuBridge(R).
Lumigent Technologies
Lumigent® Entegra™ provides a continuous audit trail of data modifications
and changes to database structure and permissions. With Entegra, IT
organizations can address 21CFR11 audit requirements by monitoring,
alerting, verifying, investigating, and reporting on data activity.
Traditional approaches to auditing database activity, including triggers,
fall short as they miss certain kinds of activity, introduce a false sense
of security, and interfere with system performance.
Maintenance Connection
Maintenance Connection provides Web-Based Maintenance Management Software.
Features of our Web-Based CMMS Software include Work Order Tracking,
Preventive Maintenance / PM Software, Asset Management, Built-in Procedure
Libraries, Inventory Tracking, Purchasing, Scheduling, and Service
Requests - all available by simply using a web browser.
Manufacturing
Applications eXperts
Manufacturing Applications eXperts, Inc. offers a full range of automation
solutions, from bar code scanners and wireless networks to fully
integrated solutions, to address the needs of Manufacturing, R & D,
and Distribution. Our solutions address operational issues in process
control, operations management, warehouse management, inventory management
and quality control. All solutions meet the requirements of 21 CFR Part
11.
MARC Global
The MARC Global supply chain execution suite, which includes a best-of-breed warehouse management system, has enabled clients to pass rigorous FDA GMP audits. MARC delivers 21CFR11 functional compliance; true lot, date and expiration control and tracking; stringent audit and accountability methods; both lot quality and pallet quality status attributes; uncompromising security and records management; and out-of-the-box, upward-compatible software that minimizes future validation expenses.
Mastek
Mastek is a global IT applications outsourcing company With impeccable
quality credentials of highest Software-CMM level 5, People-CMM level 3
and ISO-9001; with 93% on time delivery track record. Mastek offers a wide
range of software services, core being Systems Integration, Applications
Management, Offshore Outsourcing.
MatrixOne
MatrixOne is the leading provider of product collaboration software.
The company's eMatrix collaboration platform and Value Chain Portfolio
provide a flexible infrastructure for establishing business-to-business
collaboration between trusted customers, suppliers and partners. eMatrix's
proven ability for archiving and auditing documents has enabled users to
easily achieve 21CFR Part 11 compliance.
Matrix
Technologies
Matrix Technologies is an enterprise wide integration company with
extensive experience in the pharmaceutical, biotech and food industries.
Our MES experience can help with global company projects and integration
of your compliance guidelines at a local level or corporate wide,
including 21 CFR Part 11 requirements. Our quality system is ISO 9001
certified and Matrix has been a leader in the software integration market
for over 20 years, which gives us the experience to meet your information
and production goals.
MDT
Software
AutoSave automates the way you manage change. Our
field proven software supports and protects your programmable device
software programs and files by automatically performing a multitude of
change related functions. AutoSave is easing the burden of Part 11
compliance every minute of every day for the world’s leading
pharmaceutical manufacturers.
MetricStream
MetricStream makes Quality*Stream - a 21 CFR Part 11 compliant software
solution for CAPA and quality management at medical device and systems
companies. Quality*Stream is a fully web-based system that is used by
customers, suppliers, and internal personnel to log internal quality,
supplier quality, and CAPA issues and track them to completion.
Quality*Stream also provides dashboards with quality metrics and a
searchable corrective action repository.
Metropolitan Computing
Attention: Software Developers and Original Equipment Manufacturers! Make
your product 21 CFR Part 11 compliant in 24 hours! ActiveX component –
fully compliant and validated, easy to integrate with any Windows
software. Metropolitan Computing Corporation, East Hanover, New Jersey,
U.S.A. This product is ideal for equipment manufacturers with a dedicated
computer system. For a risk-free offer, contact us at (973) 887-7800 or
mail@mcc-online.com. We are open 9-5 EST.
MindSpan Engineering Services
MindSpan is a group of advanced system integrators intent on using
appropriate new technologies. Consultation, training, and implementing 21
CFR Part 11 systems. We'll help you build a machine, upgrade a process, or
perform a study. MindSpan is not tied to any particular vendor. We feel
strongly that the way of the world is to determine the particular needs of
an individual project and leverage options to execute the best possible
solution.
MRO
Software
MRO Software is a leading provider of e-Business solutions for strategic
asset management. The Company's asset management solutions allow customers
to manage the complete life cycle of strategic assets including: planning,
procurement, deployment, tracking, maintenance and retirement. MRO
Software's flagship solution, MAXIMO, provides e-Signature and e-Audit
configuration capabilities for enterprises requiring enhanced security,
such as FDA 21 CFR Part 11 regulatory compliance.
Neolytica
For a low monthly fee Neolytica provides access to the world class LIMS
via ASP. Powered by the world class Nautilus LIMS, LIMS-ASP dramatically
reduces the need for upfront hardware and software costs.
NeST
Technologies
NeST Technologies Inc is a global IT services provider with a special
focus on the bio/pharmaceutical sector. Our clients range from the Global
2000 to the Fortune 500. We have been engaged in end to end 21CFR11
compliancy services for leading laboratory instrumentation vendors. Our
assessment at SEI CMM Level 5, and focus towards EAL3 certification for
security solutions positions us to bring your product to market on time,
within budget ensuring the highest quality standards.
NetRegulus
NetRegulus offers product quality intelligence software and services for
FDA regulated medical products organizations. Our user-friendly, 21 CFR
Part 11 compliant, PQIntelligence™ Software System keeps everyone
involved in a product's life cycle on the same page. PQIntelligence allows
firms of all sizes to collect, analyze, report, share, and act on critical
regulated data within one streamlined package. Use PQIntelligence for
clinical studies management, complaint handling, CAPA management, audit
management, and other regulatory needs.
NEXL
NEXL, privately held since its inception in 1989, is one of the fastest
growing IT providers in the country. The past 10 years have witnessed the
demands of increasingly complex business environments, and a scarcity of
technical resources. NEXL has responded to these changes and grown into a
leading provider of professional services and solutions that facilitate
e-Commerce and enterprise computing companies.
NEXL has partnered with EMC to help companies meet 21 CFR Part 11
requirements.
Novasci
Partners
Novasci Partners uniquely combines business and technology to rapidly
improve the efficiency of life sciences companies. Information technology
systems that streamline the drug lifecycle are planned and built by
experienced high performance teams.
Novatek
International
Novatek is known worldwide for leadership in pioneering 21 CFR Part 11
compliant solutions for the entire product life cycle of healthcare
quality operations. Novatek provides solutions for manufacturing,
packaging, and quality assurance and control. This comprehensive
capability is delivered by NOVA-LIMS at the core, and complementary
applications that serve specialized needs. Our Products include: Automated
Packaging Component Analyzer (APCA); Enviromental Monitoring; Finished
Product Analyzer; Raw Material Analyzer; Instrument Calibration and
Preventive Maintenance Program; Stability Program.
Noverant Inc.
Employee Qualification (EQ) solution is a comprehensive,
state-of-the-art learning management system targeting for FDA regulated
industries. It offers seamless tracking and automatic management of
training at all employee levels. EQ supports all types of learning
including SOP, courses, seminars, assessments, E-Learning, video, etc.
and fully complies with 21 CFR Part 11. EQ easily connects to your
document management system of choice as well as any HRIS and email
server.
Located in Raleigh, NC, USA 919-861-4540.
Ocimum Biosolutions
Biotracker™ is a multi-platform,
multi-user, cost effective Laboratory Information and Knowledge Management
System designed to meet today and tomorrow’s life sciences information
management requirements. It is a GLP compliant LIMS built on the
guidelines of USFDA 21 CFR Part 11.
The Features Include Project Management, Project Tracking, Resource
Scheduling, Inventories, Report Engine, Sample Tracking, Plate Tracking,
Instrument Interfacing, and Audit Trails. LIMS at a price your eyes
will not believe.
Omnify Software
Omnify Software provides business-ready product lifecycle management
solutions for small to mid-size medical device and medical equipment
manufacturers. The Omnify product suite provides a single environment for
sharing product data among the design environment, enterprise and supply
chain, facilitating 21 CFR Part 11 compliance through features such as,
history tracking, e-signatures and e-signoffs. In addition, Omnify helps
to improve product quality and reduce development cycles and costs.
OmniRIM
OmniRIM Solutions provides records management software for laboratory
notebooks, trial master files and FDA submission documents for the
pharmaceutical industry. Our system is entirely web-based and complies
with 21 CFR requirements ensuring the authenticity, integrity, and
confidentiality of records from the point of creation to the point of
receipt by the FDA. Our software is designed to consolidate
active/inactive file management and apply retention schedules to meet GLP
guidelines.
ONG Automation
O.N.G. Automation are the official Rockwell Automation (Allen Bradley)
and Foxboro I/A DCS Authorized integrator in Ireland, providing us direct
access to the vast range of services and support which is available from
both Companies. O.N.G. Automation has proven experience in the
implementation of Control Systems from design stage through to final
commissioning, In the Pharmaceutical, Biochemical, Food, Water and
Electricity generation industries. We specialize in GAMP3 and 21 CFR part
11 compliant systems.
Online Business Applications, Inc.
Online Business Applications, Inc. is a leading provider of Medical
Communications software. Our core software solution, IRMS, is the most
widely used Medical Information software package available today. IRMS
has been deployed globally. Now IRMS is available with Adverse Event and
Quality Assurance modules and integration with leading CRM solutions
including Siebel.
Optimal
Industrial Automation
Optimal Industrial Automation is a leading UK supplier of automation
solutions including process & machine controls, vision and other
inspection systems, on-line printing & print verification systems,
tracking & line efficiency monitoring, MES/ERP systems, six sigma
metric measurement and validation services. We have supplied many systems
compliant with GAMP 4 and 21 CFR part11 to many leading blue chip
pharmaceutical manufacturers and OEMs.
Oracle
Oracle is helping Life Sciences companies run their businesses more
efficiently and in regulatory compliance (including 21 CFR Part 11).
Oracle’s applications and technology are currently being used by leading
Life Sciences companies in every facet of the product life cycle from
Discovery through Production. Significant improvements have been achieved
in clinical trials, adverse effects reporting, cGMP, and administrative
ERP.
Orbis
Information Systems
Orbis Information Systems is an international systems integrator,
specializing in supply and integration of information management systems
for process manufacturing and laboratory automation. Orbis provides best
class products including the world’s leading laboratory and
bioinformatic software from Thermo LabSystems, and the full range of
real-time data acquisition and plant modeling applications from Aspentech.
Orcim
Soft
ORCIM Soft, Inc. USA is a critical solutions provider that specializes in
providing Healthcare, eDiagnostic, CRM solutions by giving eConsultancy
services, as specific tailor made solutions and also as standardized
products. Offering a wide range of services that include interfacing,
customization and development, ORCIM delivers high quality standard
eBusiness solutions that can seamlessly weave into customer environments
thus helping them to automate various aspects of their business.
Orologic
OroLogic is a manufacturer of time tracking/project management and service
management software. Our products are used by any kinds of organizations
of all sizes. Our solutions are easy to setup and trial versions are
available for download from our web site.
Palisades Technology
Partners
Palisades' ePharma Solutions for R&D, Clinical Trial Management, Safety
Reporting, SFA, and CRM focus on providing key strategic and technology
services that allow our customers to achieve operational efficiencies and
competitive advantages. Palisades' deep pharmaceutical and technology
experience can provide value through engagements such as: - Developing a
Technology Road Map - 21 CFR Part 11 Remediation - Integration of
corporate systems - Business Process Management (workflow) solutions.
Patni Computer Systems
Patni Computer Systems is notable player in the space of Product
Realization Services and Systems Integration in the Industry domains of
Industrial Automation, Consumer Electronics, Medical Electronics and
Life Sciences, Automotive Electronics and Information Storage. Patni
leverages its SEI CMMI level5, ISO 9001 and Six Sigma Quality processes
in offering high quality, cost effective and first time right, product
development and System Integration Services in Medical, Life Sciences
and Pharma.
PC
PAL
With over ten years experience in software development PC PAL's clients
include the medical profession and pharmaceutical companies. Their products
include data management software for clinical trials, long term follow up
surveys and electronic growth charts, (used in over 40 countries) of which
they are the recognized world leaders
Pelikan Technologies
We are providing laboratories, medical/chemical research companies with a
general monitoring and alarm system. Various laboratory devices such as
clima chambers, refrigerators, autoclaves etc. independent of the
manufacturer can be integrated either by installing separate sensors or by
connecting to the devices via serial o ports or any data communication
port..... Please ask for detailed description - we will provide by email !
Performance Automation and Controls
Performance Automation and Controls, LLC (PAC for short) is a company
focused on the pharmaceutical industry. Together with our sister company,
Performance Validation, we provide a range of services in the area of Part
11 compliance including consulting services, gap assessment, procedural
controls development, remediation and computer systems validation.
Pharmagraph
Pharmagraph offers complete 21 CFR part 11 compliant solutions for clean
room and facility monitoring systems. From supply of sensors, through
installation, system qualification, training and calibration, we work with
you at every stage to ensure that systems are delivered on time and to
specification. Measuring Temperature, Relative Humidity, Pressure, Air
Flow and Particle Counts, our systems deliver succinct, secure results.
Pharsight
Pharsight provides industry-standard PK/PD
modeling (WinNonlin and WinNonMix), and trial simulation tools (the
Pharsight Trial Simulator), and has introduced the Pharsight Knowledgebase
Server™,
to support 21 CFR Part 11 compliant knowledge management, providing an
integrated and collaborative repository for the PK/PD data, models, and
analysis results used in regulatory reports or produced as part of the
optimization of a clinical trial design.
Phase
Forward
Phase Forward Incorporated, the leading provider of clinical informatics
for drug development, is dedicated to helping pharmaceutical,
biotechnology and medical device companies bring needed drugs and
therapies to market faster. The company offers proven solutions in
electronic data capture (EDC), clinical data management (CDM), electronic
patient diary, adverse event reporting (AER) and regulatory affairs
product data management as either an integrated solution or as stand-alone
applications based on each customer's specific needs.
Pilgrim
Software
Pilgrim Software, Inc is a leading provider of collaborative e-business,
enterprise quality and procurement solutions that increase productivity
and reduce cost in the global manufacturing community. Pilgrim's
innovative Q&MIS® suite addresses aspects of quality
management and business performance within FDA regulated industries. The
Q&MIS FDA edition helps FDA regulated industries address the process
requirements of 21 CFR Part 11 including electronic records management,
electronic signatures, electronic passwords, audit trail, and validation.
Plateau
Plateau manages learning and knowledge processes for over a dozen
pharmaceutical and medical device corporations, and has years of
experience helping global enterprises such as Bristol-Myers Squibb, Bayer,
Genzyme, Guidant and Alcon comply with FDA 21 CFR Part 11 and additional
regulations. Plateau’s Learning Management System includes electronic,
PIN-based signatures and unique time stamps to ensure the validity and
auditability of electronic training records.
Plutus Enterprises
The good news is that helping companies grow their revenue and profits is
what Plutus Enterprises is all about. Since 1991, we have helped companies
across a wide swath of Life Science's disciplines including
pharmaceuticals, biotechnology, medical devices and diagnostics, CRO's and
medical supplies. We combine our deep understanding of the industry's
business drivers with properly leveraged technology to deliver high value
solutions that allow companies to face down their toughest challenges
PopWare Inc.Popware provides add-on
software products and services that enhance and extend the capabilities
of leading CMMS/EAM packages such as Maximo in regulated industries.
Prime
Technologies
ProCal 2000 was developed by Prime Technologies, Inc. with detailed input
from QA personnel, calibration technicians and IT professionals within
FDA-regulated facilities. This industry-specific approach has enabled many
pharmaceutical manufacturers to create a paperless calibration department
that not only complies with 21 CFR Part 11 but is more efficient as well.
Princeton
Softech
Princeton Softech’s industry-leading products and services can help
pharmaceutical companies meet and exceed 21 CFR Part 11 requirements for
archiving research data and systems testing and validation. These tools
work with all the leading database management systems, and can enhance the
effectiveness of today’s 21 CFR Part 11 solutions
Prisym ID Inc
Prisym ID provides validated labeling systems for the Life Sciences
market. Our labeling systems are developed to GAMP guidelines and are
suitable for pharmaceutical, clinical trial and medical device
manufacturing companies.
PRISYM Medica is the world's only labeling software specifically
developed to meet and exceed the FDA's current requirements including
FDA 21 CFR Part 11 and Structured Product Labeling (SPL) regulations.
PRO IRB
PRO_IRB™ is a Microsoft Access-based Institutional Review Board Software
Application providing productivity and compliance assurance tools for
managing the Institutional Review Board process. The application was built
using MSAccess - the most widely used database tool in the world. And,
best of all, no prior experience with Microsoft Access is required!
Pro-ductivity
Systems, LLC
Pro-ductivity Systems, LLC is a recognized leader and provider of
comprehensive and affordable 21cfr Part 11 compliant systems for LAN/WAN
based training management and browser based learning management.
Systems are installed at over 500 of the top bio-tech, pharmaceutical, and
medical device companies worldwide. Services include certified training.
Call us at 1-866-776-8876 for a no cost trial of all systems.
Process
Analysis & Automation
Process Analysis and Automation provides 21 CFR Part 11 solutions.
Our products include Solution11 XL™ – which provides full compliance for Microsoft® Excel including user management, secure audit trail, electronic signature, encryption/decryption, supports templates, macros and add-ins.
We also provide the unique Solution11™ Toolkit for rapid development of Part 11 applications – templates provided for C++, VB and LabVIEW developers.
ProcessPro
ProcessPro is the leading Windows-based process manufacturing software,
designed especially for small to mid-sized manufacturers who must adhere
to FDA regulations, including 21 CFR Part 11. ProcessPro is a robust
process manufacturing system that integrates all areas of your business
processes from order entry through manufacturing, shipping and accounting.
Process Solutions
Process Solutions provides a complete Stand-Alone solution for equipment
and processes requiring 21 CFR Part 11 compliance, using off-the-shelf
software and hardware. The package is simple, affordable, and can be
customized to any new or existing pharmaceutical equipment.
Proscon
Solutions
Proscon Solutions are an information systems & technology solution
provider, established to cater to the growing need for reliable, quality
turn-key information technology systems and services. We deliver a
complete set of solutions, technologies and services designed to tackle
complex, mission-critical, technology challenges - from requirement
analysis to implementation and long-term support.
Proteans Software Solutions
Proteans Software Solutions - offshore Software Product Development
Company in India. Software & IT outsourcing company specialized in
Product Engineering Services, Microsoft .Net Custom Software Application
Design, Development, Integration & Testing
PTC
PTC develops, markets, and supports software solutions that help
manufacturers win with superior products. PTC is the world's largest
software company with a total commitment to product development. PTC's
Collaborative Product Development solutions enable companies to achieve 21
CFR Part 11 compliance, while simultaneously delivering 3 basic results:
customer intimacy, cost-efficiencies, and innovative products. The company
services more than 33,000 customers worldwide.
Pumatech
Pumatech, Inc. (NASDAQ:PUMA) provides organizations with a comprehensive
suite of software products and services that synchronizes and distributes
critical information throughout the enterprise. Intellisync and Sat Forms
software from Pumatech is used by global pharmaceutical and healthcare
organizations, and is the sync standard in the majority of the F1000.
Contact Mel Denehan at mdenehan@pumatech.com.
Q-mation
Q-mation has developed a set of Active X controls and script functions
that significantly ease the development of 21 CFR Part 11 compliant
applications using Wonderware's InTouch 7.x software. These tools help
address the regulation's requirements around security management,
electronic signatures and authority checks (i.e. - UserID/Password
maintenance, use of Full Printed Name, "Done by/Checked by"
authority checks etc.). In addition, we've developed Audit Trail
technology that can be applied to any Microsoft SQL Server database table.
QSolve by Agate Software
QSolve software products help you create and manage any quality management
system in a Web environment. QSolve was designed for creating and
maintaining a controlled, online, system that will positively impact your
productivity, efficiency and bottom line. Result-Buy back your time.
QSolve is flexible enough to meet the requirements of any quality standard
including: ISO-9000, QS-9000, ISO-14000, ISO-18000, TS16949, and many
others.
R4 Global Solutions
R4 Global provides strategy, planning, implementation and integration of
pharmaceutical supply chain systems, with a specialized area of focus in
RFID and 2D barcoding. Our pharmaceutical clients represent over $85
billion in annual sales, and are working with R4 to develop CFR Part 11,
e-pedigree and global track and trace solutions. R4 is headquartered in
San Francisco, with additional locations in New Jersey, Boston, Michigan
and Atlanta. Web site address: www.r4gs.com.
RapidSolution Software
RapidSolution has developed different applications for connecting devices that are not fulfilling the 21CFR Part 11 requirements itself to a systems in a way that the whole system fulfills them again.
RapidSolution offers consulting services belonging to Part 11 problems as well as doing concrete implementations.
RBC
Cable
RBC Cable is a Networking and Infrastructure Company providing a full
range of network hardware and related cable components to companies across
the US. Our staff is certified in leading technologies to help you design
and implement infrastructure wiring solutions for the future. The
following is a list of some of our services: Online Access, T/2000
Server-Based Networks, Active Directory Services & W2K Deployment,
Fast EtherNet/GigaBit EtherNet & Fiber, Voice & Data Cabling, IP
Telephony, Video Conferencing & Auditorium Sound Systems, CD-Rom
Servers, Tape Backup Systems, Install/move network drops.
RealQM, Inc.
RealQM delivers a service that immediately enables distributed
organizations of all sizes to collect, track, secure and analyze their
quality-related information. We provide an integrated and scalable
Quality Management System (QMS) that is delivered via the Web with nothing
to install and minimal training required and can be up and running in days
- not the months required by traditional QM software.
Rendition Networks
Rendition Networks has developed a software product that tracks and
manages network configuration change activity across routers, switches,
firewalls,and load balancers. Rendition's configuration change management
software provides network managers better insight, accountability, and
control over these changes, resulting in more efficient network operations
and effective IT staff.
Replicon Inc.
Replicon Inc. is the developer of Time Sheet Software, a complete web
based timesheet management application for workgroups.
Resource
SE
Resource SE designs and develops tailor-made software solutions, for
control and supervision of appliances, instruments and other
electronically based equipment. Resource SE has the technical expertise
necessary to undertake even the most extensive software projects. Our
unique spiral development model and project team working methods ensure
that we meet the highest quality requirements, including ISO 9001 and FDA
standards.
Rockwell
Software
Rockwell Software, a leader in industrial automation software solutions,
develops the broadest solution for helping businesses comply with the 21
CFR Part 11 regulations. From the industry’s most comprehensive
configuration management solution through maintaining and managing
information produced from plant floor systems, Rockwell Software leverages
our preferred compatibility with A-B controllers and our FactoryTalk
technologies to provide a solution suite that integrate quickly and
easily.
S.S.Systems and Solutions Pvt. Ltd.
Quality Software Solutions with full 21 CFR Part 11 compliance.
We have software interface options for lab equipments like Brookfield Viscometers , pH meters , Weighing Balances or any other equipment having RS 232 / RS 485 / Modbus / 4-20 mA / 0-10 V Dc output options.
Saba
Saba is the leading provider of Human Capital Development and Management (HCDM)
solutions, which consist of Internet-based learning, performance, content
and resource management systems, learning exchanges, integrated content
and related services. Customers around the world rely on Saba to increase
competitive advantage by rapidly building critical skills throughout their
extended enterprise of customers, partners, employees and suppliers.
SAVANT
SAVANT is a 25-year-old publisher of interactive computer-based training (CBT)
and audiovisual programs for analytical laboratories. The programs are
principally on different techniques in Spectroscopy and Chromatography.
Our programs sell all over the US and internationally to corporations,
institutions, hospitals, universities, government laboratories and
consultants.
Savitr Software Services
Savitr offers process driven quality offshore software development in India. Savitr has a proven methodology for offshore software development and is a leading offshore software development company, based out of Hyderabad, India with over six years of track record. Savitr offers its offshore development services in web branding, web development, e commerce and software testing & quality assurance.
