Solution Providers
Electronic Document Management Systems
To add a solution provider, go to our
Submission Page
Achiever Business
Solutions
Achiever Business Solutions supply software products to many of the
world's largest pharmaceutical and clinical trial companies for managing
their documentation in line with 21 CFR Part 11. The Achiever Plus
products can be implemented in a short period of time, enabling
corporations to realize a very early return on investment.
AegisDRM
FDA 21 CFR Part 11 Compliance added to all your organisations Microsoft
Office Documents and Web based applications.
Amadeus
International
Amadeus delivers a web-based comprehensive suite of integrated software
modules that help organizations effectively manage quality processes and
achieve sustained regulatory compliance. The foundation of the suite is
a robust workflow engine coupled with advanced modules for CAPA, audit
management, non-conformances, regulatory document management, and other
vertical solutions.
Arbortext
Arbortext is the leading global provider of XML-based software for content
creation, editing and multichannel publishing. Within the Life Sciences
markets, Arbortext is a component to solutions that include automated
labeling and packaging, Call Center information replication, Medical
Information Systems, and manufacturing documentation support.
Headquartered in Ann Arbor, Michigan, USA, Arbortext has offices around
the world.
Biomedion
BioMedion solutions enable your company to establish a consistent 21 CFR
part 11 compliant IT-environment that easily integrates systems and
applications already running at your site (legacy systems). The EDMS BM-windream
provides the part 11 compliant backbone for all electronic data within
enterprise networks. The consistent documentation and validation of its
functionality guarantee optimal support for our customers during
validation processes (IQ, OQ, PQ).
CADDIS
CADDIS is an Electronic Laboratory Notebook monitoring all pharmaceutical
development activities: - definition of studies: recipe, process,
operating conditions - data acquisition from test and manufacturing
equipment - data analysis and automatic reporting - indexing and archiving
compliant with CFR21 part 11. All data archived in CADDIS may be used to
generate chapters of NDA files or Master Batch Record
CDC
Solutions
CDC Solutions provides unparalleled document assembly, delivery and publishing solutions for complex regulatory documents and submissions.
CDC Solutions offers highly scaleable publishing products capable of handling
submissions to regulatory agencies, ranging from BLAs to NDAs, including Cross Referencing,
Volumization, Printer Control, Electronic Output, Templating, conversions and PDFaqua for security watermarking.
Cimage
NovaSoft
Cimage NovaSoft is a global provider of eBusiness application solutions to
industry, solutions that enable enterprises to improve their business
performance through better management of their information. Over 120,000
users across 650 sites in 30 countries employ Cimage NovaSoft
solutions-making it one of the most popular products in the market. We're
a business partner supplier who understands and is proven in FDA regulated
industries.
CoVisible Solutions
India Pvt Ltd
A Web-based document management system - File Approval Management System
(FAMS) assists decision makers with easy, fast & intelligent document
storage-retrieval to make informed decisions. It helps convert paper
dependent organization to minimal paper user. Business-critical
documents are preserved for years and available at fingertips with
highly responsive search features. Highly configurable built-in workflow
management system automates the flow of documents across departments &
offices.
Correlate K-Map
Correlate offers life science customers the ability to manage all
regulatory documents and processes through its award winning visual
document management capability. Correlate K-Map template-based approach
enables companies to lower their cost and time in managing their FDA
submissions and achieve a greater return on investment while maintaining
compliancy with 21 CFR Part 11.
TrialWorks Clinical Trials
Management Software by ClinPhone
TrialWorks clinical trial management software by ClinPhone is powerful,
user-friendly, 21 CFR 11 compliant trials management software.
TrialWorks is being used globally by pharmaceutical, biotech, medical
research companies, and CROs and other specialized research
organizations.
This site submitted by Intersect Communications as part of a web
marketing solution for ClinPhone.
DATAGENIX
Datagenix was formed in 2000 to leverage the power of imaging and
document management forms processing technology for use in conjunction
with legacy and new generation systems. The company has evolved into an
entity that creates state of the art forms processing and document
management systems for medical, biotech and health insurance companies.
Deal
Management
DMS provides a unique blend of software and services to digitize your
paper trail. DMS staff will organize and index your documents, then scan
and convert them into a keyword searchable database. This database can be
published in a secure online document vault, or on CD-Rom. DMS solutions
are 21CFRPart11 compliant and are used for clinical trials, laboratory
notes, and other important records.
DistinctHorizon Corporation
MxDoc, the Regulatory Compliant Electronic Document Management solution,
provides a secured collaboration platform, compliant with 21CFR part 11.
MxDoc includes: electronic signatures, audit trail, versioning,
metadata, workflows, PDF conversion and report generation, SOPs and
more. Our solutions are provided with professional services such as
implementation strategies, processes, and procedures related to
electronically managing documents that support the submission process.
Document
Control Systems
Document Control Systems, Inc. (DCS) is the leading software developer of
document control and document collaboration software helping GXP companies
meet and exceed requirements for 21 CFR Part 11. Proven validation test
plans are available for companies to do their own software validations, or
let the DCS experienced professional services team, validate the system
for you. DCS has helped hundreds of users with document control needs and
regulatory compliance.
Documentum
Maintaining a GMP environment within this structure requires control
and access to content as never before. Documentum has proven solutions
that address all these concerns. With over 80 installations in the largest
global pharmaceutical companies, Documentum solutions can help you manage
the generation and delivery of high quality content from R&D through
to commercialization and production in a secure e-business environment.
DocuTrack - Integra, Inc.
The Integra Group specializes in the design, development, and
implementation of mission critical pharmacy information systems. Our
market leading DocuTrack pharmacy document management system is a
web-based application that enables you to electronically receive, route,
process and archive all your pharmacy documents while seamlessly
integrating with your existing pharmacy information system.
DocWave
DocWave provides Life & Health companies with high level consulting
services and business solutions. Compliant with pharmaceutical good
practices, FDA and International regulations, QualWave™ is a complete
solution for managing Quality Documents, (integrating 21CFR part 11
rules). QualWave™ is a part of our " Wave " business solutions
suite for the R&D, QA, Manufacturing, Distribution and Marketing Departments of Pharmaceutical, Cosmetic and Food Companies.
Doxpub, Inc.
Doxpub is a publishing company specializing in documents for Good
Laboratory, Clinical and Manufacturing Practices. All Doxpub
publications are made available through a secure online store where they
are cross-referenced with relevant standards from organizations like
ISO, ASQ, ASTM, AAMI, and others. Doxpub also offers document-related
services including content assessment and template conversions.
Ecora
Ecora Software provides automated solutions for documenting and managing
change in an IT infrastructure. Ecora’s main product is Configuration
Auditor, which generates detail, plain-English reports on configuration
settings across an enterprise. Reports provide hard evidence for proving
Part 11 compliance, and are vital for internal security and business
continuity plans.
eDocSecure Inc
eDocSecure, Inc is a document imaging / document management solutions provider, featuring packaged turn-key solutions, in both a client/server and web- based software environment.
Mission Statement: “Leverage a proven, best-of-breed set of technologies to digitize, store, manage and retrieve paper- based information, for secure access, anytime, anywhere”
EDRM Solutions
Secure and scalable enterprise content management (ECM) solutions. Whether
you need a solution for physical file management, or robust electronic
document management with integration to recordkeeping and other
line-of-business applications, we can help you. With ECM implementation
experience at several leading Pharma companies, as well as participation
in several 21 CFR Part 11 audits, we can provide a focused approach that
will satisfy your requirements and exceed your expectations.
Educe Solutions
Pvt Ltd
"DocsExecutive", Document Management System : GAMP guidelines based
Document for SOPs, PS, QAPs, Inter-Office Memos etc with 21 CFR and
audit trails, Document version management and Electronic Signature.
"Dossier-Mgmt", a e-CTD submission software based on ICH 3.0, US 2.01
and EU 1.0 DTD Specifications. Approved e-CTD submissions for DMF and
ANDA from USFDA.
Eigner
Eigner is a global provider of precision product lifecycle management (PLM)
solutions that allow engineering data to be used throughout the extended
enterprise to improve the operational efficiencies of the entire product
lifecycle, enabling organizations to capture customer requirements, focus
on innovative product design, participate in collaborative development,
ensure precision manufacture of quality complex products, and better
manage product maintenance and service. Founded in 1985, Eigner’s
customers operate worldwide in a wide range of markets, including
aerospace and defense, automotive and transportation, high tech,
machinery, medical and heavy equipment.
Electronic Document Solutions Cubed
Each project the EDS3 staff has accomplished comes with its own unique
details. Our flexibility has been one of our greatest reasons for success.
Please peruse our portfolio of projects.
Enmed
Enmed
is a leading provider of comprehensive, flexible, and integrated solutions
that improve the speed and efficiency of drug, biotechnology, and medical
device development. Enmed’s flagship offering, Acceliant™ Clinical
Trial Solution, is an Internet-based, application service provider (ASP)
solution designed to reduce the time, risk, and cost of clinical trials.
First Consulting
Group
First Consulting Group (FCG) has combined the industry's best
practices, state-of-the-art technology, and consulting services to produce
FirstDocs™ for GMP, a comprehensive prepackaged electronic document
management solution in support of pharmaceutical manufacturing and quality
processes. It's a part of our FirstDocs™ solution suite, which
offers a set of services and software for research and development, case
report form management, and regulatory submissions.
Global Cold Chain Solutions
Global Cold Chain Solutions (GCCS) is an Australian-owned organisation
specialising in the provision of complete solutions for the Cold Chain.
21 CFR PART 11 compliant web-based monitoring system called ETM. Data
integrity is maintained as the data downloaded is controlled by
administrator, and can be emailed as a jpeg image – therefore cannot be
manipulated. Program and download loggers via ETM. Immediate access to
information for all parties in the cold chain.
Global Vision
Global Vision is a world leader in the design, manufacture and delivery of
automated Quality Control Inspection Systems which integrate corporate
workflow solutions that comply with 21 CFR Part 11 technical requirements.
It offers a complete portfolio of innovative solutions for any quality
control/inspection or proofreading application, including file-to-file,
intelligent OCR, artwork inspection and high-security character inspection
systems.
GXPharma
GXPharma - Solutions for Compliance, the first product-based cross-value
chain content management solution set for the pharmaceutical and
healthcare industries, only available from the alliance of PwC Consulting
and Documentum. The GXPharma suite manages content from cradle to grave
across the pharmaceutical value chain, from R&D to manufacturing &
quality, through to sales & marketing. Its product functionality
provides Internet scalability, regulatory compliance and enterprise
content integration.
Hummingbird Ltd.
Hummingbird DM™ (Document Management)
and Hummingbird RM™ (Records
Management) products facilitate the proper management of non-database
electronic records, enabling control of an electronic record from creation
through revision, dissemination, retirement and destruction. The
Hummingbird DM and Hummingbird RM product(s) can be a key component of a
regulated industry's overall 21 CFR Part 11 compliance strategy.
Whitepaper
ICM Corporation
ICMC provides a fully integrated Quality Management solution, including Management of Change; Document Control, E-Signature, CAPA; Workflow/Business Process Automation (with an integrated VISIO based designer), Complaint Handling, Nonconformance Management, Audit Findings, as well as a unique pricing structure.
Inkorus Solutions (I)
Pvt. Ltd.
Archimed eDMS is an integrated document and workflow management software
solution, offering full automation of the document flow, work processes
and decision control.
Archimed eDMS is a modular system that allows the customer mixing and
matching modules to address any specific need. All modules operate as
standalone applications as well as integral part of the system, using a
common database, users, rights and management.
Infotehna
Infotehna is dedicated to providing document management solutions to pharmaceutical companies. Solutions are developed to help professionals to develop, maintain, prepare, assemble and deliver documents and dossiers, including comprehensive reporting tools aimed to manage all procedures, monitor time schedules, and accurately perform work tasks. my-Process is web based solution developed on Documentum for managing controlled electronic records in the GxP environment.
KnowMetrix
KnowMetrix provides 21 CFR Part 11 compliance solutions including
Electronic Signatures, Work Flow, Document Management, GMP consulting.
Learning11
Just because you build it doesn't mean they will come! Learning 11 is a
project deployment company that develops custom learning applications and
deployment strategies to help ensure that your document management system
and processes are successfully deployed. We develop custom e-Learning
around EDMS and SOP's using simulation technologies, job aids and help
materials to support a successful deployment.
Lennox Hill
A web-based and on-demand document control software system for Quality,
Environmental, Compliance and Standards Management. Our solution is
designed to meet 21 CFR Part 11 regulations and to allow you to test
each user as new and revised standard operating procedures are issued.
Liquent
Liquent (formerly ESPS) is the leading provider of content assembly
and publishing solutions for the Life Sciences industry. Built on proven,
world-class rendering technology that transforms proprietary content into
open formats such as XML and PDF, Liquent software and services are used
by 15 of the top 20 global pharmaceutical companies. We are the makers of
CoreDossierX -- the industry standard -- and provide unparalleled
compliance and validation services worldwide.
McLaren
McLaren's kVisia Document Lifecyle Applications reduce the time and cost
associated with the building and maintenance of 21CFRPart11 compliant
electronic document management solutions. kVisia Applications are based on
configurable XML technology powered by Documentum and enable a dramatic
reduction in revalidation time by retaining auditable changes. McLaren
software is used by some of the worlds leading pharmaceutical companies.
Medisurvey Interactive Medical
Communication
Medisurvey provides online EDC solutions based on a specific platform in
accordance with 21 CRF part 11
Our company develops specific online applications for pharmaceutical
industries
MIGG
Systems
MIGG Systems develops, markets and supports the Qstream Suite for
companies within regulated markets. Qstream iCompliance 4 provides an
open, scalable platform for building and deploying business solutions,
meeting regulatory requirements, powering collaborative portals and
enabling dynamic Web Sites. From the conception of a solution, to creation
and delivery of content, Qstream iCompliance 4 provides the technical
infrastructure necessary to build applications that must comply with 21
CFR Part 11 regulatory requirements. The result is a more cost effective
tool that helps companies tackle non compliance risks while integrating
frontline business objectives.
Mission3
Mission3 has developed an innovative software suite that enables life
sciences firms to effectively manage and accelerate the complete product
development process from bench to bedside via the seamless integration
of document management, project management and electronic submission
management capabilities. Mission3’s completely Web-based products (MissionFire
and FastCrossing) also enable the management of all regulatory
compliance processes and conform to the international standards.
Mystic
Management Systems
Software company that supports FDA Title 21 Part 11 compliance by
providing unprecedented software for Document Control, Workflow
Management, Electronic Records, Messaging & Notification, Web Enabled
Access and High Security Levels.
NoteBookMaker
NoteBookMaker™
is a totally secure, completely electronic Laboratory Notebook. The first
electronic notebook that looks and prints like a real notebook. This
system is easily modified and can be custom designed to fit any
organization. Available in single and multi-user formats, compatible with
all major OS's including Palm Pilot®.
Novo Nordisk IT
Novo Nordisk IT provides consultancy, development and operation of IT
solutions. Our 600 employees transform state-of-the-art technologies into
scalable, high-quality business solutions that match the quality
requirements of the pharmaceutical and biotechnological industries. The
solution is called ethoDocs and can be found at
www.ethodocs.com/
Onsphere
OnSphere develops and deploys software products that are fully compliant
with FDA 21 CFR Part 11 validation regulations. PharmaReady™ is a document
management solution developed by OnSphere based on Microsoft SharePoint™2.0
for organizations requiring management of SOPs and other documents within
business areas regulated by the FDA and other agencies.
Open
Text
Open Text’s mandate is to deploy high-value specific implementations of
Livelink for all areas across the enterprise of pharmaceutical companies.
Livelink is a collaborative commerce application used for document
management, project management and workflow. Livelink is 21-CFR Part 11
compliant and integrates with scientific applications and databases.
P-Wave, Inc.
LabCORE provides Document Management and workflow into a web based,
enterprise class application that is FDA 21 CFR Part 11 compliant.
Within LabCORE, data can be received from a variety of inputs such as
scanned documents, instruments and LIMS. It also offers role-based
security, providing access to information based on an individual's role
in the company. LabCORE provides complete traceability and audit
tracking and creates a searchable format for document and data
retrieval.
Paperless Pharmacy
Paperless Pharmacy provides software and consulting in the following
areas: pharmacy workflow, pharmacy document management, business process
mapping/improvement, and document control. It also enables clinical and
pharmacy organizations to convert their paper records to secure
electronic records with its file room scanning and archive service.
Paperless Pharmacy offers a company-wide solution that can be used by
most departments to address the issues related to 21 CFR 11.
Paradigm II
Compliance Management Software
Paradigm II Compliance Management software solution that utilizes common
file formats, Word, Excel etc. to manage documents and records to meet the
electronic signature requirements as outlined in CFR Part 11. Paradigm II
provides a web-enabled or network solution that is fully customizable to
your organization's needs.
PENSA Technology Solutions
PENSA Technology Solutions Inc. offers a knowledgeable and experienced
staff to aid your regulatory company in practical computer related
validation. In addition to consulting services, PENSA has developed their
own software validation tool called TVM, The Validation Manager. TVM gives
PENSA clients the power to manager validation protocols and documents in
electronic form and is fully compliant with 21 CFR Part 11.
Prelude
Prelude provides products and services for document and data
management applications covering the full Software Development Life Cycle.
Founded in 1989, Prelude has extensive experience in regulated industries
such as life sciences and chemicals, and a solid reference base of
clients. Our systems are 21CFR Part 11 Compliant for the life sciences
industry. We provide a lower initial acquisition cost, a lower overall
cost of ownership over the life of the product, and a corporate wide
international standard for input and viewing across your wide area
network.
Policy Technologies International Inc.
The web-based Policy and Procedure Manager features a simple and
easy-to-use process for complex document control issues. You can use the
software to create, review, approve, and read all your documents. It is
the best way to update your policy manual and save precious time spent
trying to coordinate schedules for meetings and committees.
QSI
Cost effective solution to high-end document management software TMSWeb
(Training & Document Management System) enables companies to easily
publish documents on Company intranets with optional automatic PDF
conversion. All window-based documents can be managed with revision
routing, workflow, electronic signatures (21 CFR Part 11 compliant),
change control, training records, job certification, and email.
Qualogy
As a contract service organization, Qualogy provides training,
consultancy, quality management services, quality management software,
auditing and archiving services to those working in and for the GLP, GCP
and GMP (GxP) regulated industries.
QualTrax
CCS-Inc. – QualTrax® - QualTrax document management software helps
organizations reduce costs and waste, increase efficiencies and reduce
time-to-market. QualTrax is ideal for Life Sciences, Food & Beverage and
Manufacturing companies that must comply with FDA, ISO, HACCP and QS
requirements. Since QualTrax is web-based and customizable, it’s the
perfect tool to facilitate culture change throughout an entire
enterprise.
QUMAS
QUMAS is the world leader in Enterprise Compliance Management solutions
for regulated companies. QUMAS solutions allow companies to effectively
secure, manage and distribute regulatory information in compliance with
the latest FDA and international regulations, including 21 CFR Part 11.
QUMAS' Enterprise Compliance Management solutions are finished
applications and are delivered with validation services, training and
rapid deployment services.
Revelink
Revelink is a rapidly growing software solution provider to the life
sciences industry. Revelink’s suite of compliance solutions enables
pharmaceutical, biopharmaceutical and medical device companies to meet the
regulatory requirements of FDA 21CFR11 and GAMP. Revelink offers a number
of packaged software solutions to pharmaceutical and biopharmaceutical
companies. Our products include; Document Management (cDMS, Paper Record
Entry Program (PREP) and Lifecycle Management (cLCM)
Softech's Workgroup Technology Division
SofTech's Workgroup Technology offers ProductCenter, an extended
enterprise collaborative PDM solution meeting the requirements for
electronic product data management of FDA Rule 21 CFR Part 11.
ProductCenter aids medical equipment/device manufacturers to more
effectively manage voluminous, constantly changing product data to
accelerate FDA pre-market approval and compliancy, with additional bottom
line benefit, including compressed development cycles, faster
time-to-market, and lower cost.
SOS
Integrated Business Solutions
SOS Integrated Business Solutions provides IDM solutions that combines
Document Management, Imaging, COLD/ERM, Workflow and Report Management
technologies into a single Web based application, Business Process
Automation for paper or electronic forms and documents, eForms Management,
and Electronic Signature Solutions. Our extensive experience encompasses a
full range of system integration activities, from initial analysis,
design, implementation and support.
Spade J Information
Spade J is a JAVA software solution provider based in TAIWAN. EQIP-11 is
our solution of providing a platform to help our customers to comply with
FDA's 21 CFR Part 11 regulation. EQIP-11 performs the important features
of the regulation including E-Records, E-Signatures, time stamps, system
authorities, document privileges, revision controls, auditing, operation
logs and etc.EQIP-11 automatically embeds the regulation in your routine
job so that you'll never have to worry! Please contact us: +886-7-5543800
18F-3 No.305 Min-Hwa Road, Kaohsiung 804, Taiwan.
Sycamore
Group
The Sycamore Group is helping companies comply with 21 CFR Part 11 through
Mobil Data Acquisition. Mobile wireless data capture technology provides
Environmental Monitoring departments the capability to improve quality and
productivity issues. Mobile wireless devices provide laboratory
technicians immediate and real-time access to environmental data systems
while meeting regulatory compliance standards. The real-time communication
eliminates redundant data entry time, reduces the need for redundant
testing, ensures data integrity and ultimately increases productivity.
Valid Systems
Valid Systems provides components and solutions for electronic
recordkeeping in compliance with the guidelines of the regulatory
community. Using a centralized policy management interface, the
ValidRepository recordkeeping policies can comply with your specific
regulatory requirements. Policies can be set on document authoring
practices, document versioning, audit trail, witnessing, and other areas
of record creation and management to support 21 CFR Part11.
W4
W4 (World Wide Web Workflow) originates from the idea that workflow brings
to the Internet a tool allowing better management of information access
Merging workflow and Internet had a tremendous impact, when it comes to
implementing and rationalizing Business processes and flows. Workflow
provides all the power, speed and security linked to the business process
automation. Workflow links men, applications and processes, while tracing
all operations during an action lifecycle.
Winchester Business Systems
Winchester Business Systems, Inc has been a leader in providing software
and implementation services to Fortune 1000 companies worldwide since
1989. We deliver custom-tailored software and professional consulting
based on the Lotus Domino and IBM e-business technology. The management of
and greater access to knowledge is the principal concern of Winchester. We
have particular skill and expertise in understanding the concerns of the
pharmaceutical, biotech, and medical device industries.
Workshare
Technology
Workshare Technology™ is an industry leader in developing and
bringing premier document change management solutions to a variety of
document-centric markets such as the pharmaceutical industry. Workshare is
known for its revolutionary DeltaView®, and Synergy™
software solutions that enable efficient management of changes on the
content of valuable, and often complex documents.
Zequel
Technologies, Inc.
Zequel Technologies, Inc. is the developer of DynamicPolicy™ a Web-enabled
application that helps companies to electronically manage their policies
and procedures. Learn how our solutions can help you comply with FDA
21 CFR part 11, HIPAA, GLB, ISO 9000, ISO 14000, ISO 17799, and Sarbanes
Oxley requirements.
