Solution Providers
Compliance/Validation Services
To add a solution provider, go to our Submission Page
@Pharma
@Pharma is a validation and GxP (GMP,GLP,GCP) regulatory service provider,
adding real value to our clients' business in the pharmaceutical,
veterinary, medical device and healthcare industries. Our qualified and
multi-lingual personnel have an extensive technical and regulatory
knowledge and can work with your staff in many areas to meet your
validation and compliance needs. We operate internationally, either from
our headquarters in Berchem, Belgium or from our local office in New York,
NY.
21CFRConsulting.com
21 CFR Consulting is a privately held virtual consulting company based out
of Southern California, which in collaboration with strategic partners,
provides compliance services to the Life Sciences Industry. Founded in
2003 and backed by a team with over of decade of combined industry and
consulting experience, 21 CFR Consulting was founded with the intent to
provide Life Science clients the personalized support and service they
require in compliance with appropriate government regulations.
AAC
Consulting Group
AAC Consulting Group Inc, provides a full range of support and
assistance to industries regulated by FDA and similar international
agencies. As new standards and regulations proliferate, AAC keeps clients
abreast of the changing regulatory landscape. Founded in 1960, AAC is an
industry leader, delivering up-to-the-minute information, interpretation
of regulations, procedural assistance, and training to our clients.
ACCESS1, Inc.
ACCESS1 provides software development and validation to the healthcare
industry worldwide meeting all 21 CFR Part 11 requirements.
Among the many regulatory applications we provide, we have CAPA
(Corrective Action/Preventive Action)and Donor Entry/Tracking systems.
Companies include Johnson&Johnson, CIBA, Serologicals, Solvay, and UCB.
ACCESS1, Inc. - 770.419.1980
ACOM
Acom provides validation services to the life science and medical device
industries. Acom supports customers in many areas of Computer System
Verification and Validation including; project management, report
preparation, planning, gap analysis, SOPs, audit reporting, change
control, etc. Acom also provides provable 21 CFR Part 11 services and
presents the results in a customized Certification Book that provides
evidence that the validation has been accomplished.
AdClin
Provides software increasing both productivity and security for biometry services. One of its feature products, dedicated to clinical reporting, produces 100% of tables and listings while significantly reducing the amount of code to type, making its validation quicker.
AdClin can deliver services with high added value, like pooling studies of disparate formats into one consistent database, thus making the information accumulated during years of research readily available for further processing.
Adea Solutions
Adea Solutions provides the services to help companies address ER/ES 21
CFR Part 11 issues and move more quickly toward compliance. This includes
strategy and planning services, strategy review, systems and process
audits, package selections, application remediation, and program
management services. Adea Solutions is a national IT Solutions provider
and has provided 21 CFR Part 11 services to some of the largest
pharmaceutical and biotechnology companies in the U.S.
ADN
ADN is a leading French Consulting Agency providing Software
Validation Services to the Pharmaceutical Industry. We provide support,
audit and technical assistance to many world-wide partners in reference to
the FDA and European regulation - including 21 CFR Part 11. We have a wide
range of knowledge and experience on various areas and projects :
Analytical Sciences (LC/GC/MS, LIMS…), Manufacturing (ERP, SCADA, MES,
LIMS…) Clinical trials (CTM…) / migration, remedial actions in
compliance with international regulations and clients' interpretations.
ADN offers global services, from User requirements specifications to
Validation Reports, to help clients improving performances and achieving
compliance efficiency.
AK Pharmaceuticals
AK Pharmaceuticals is a dedicated business focused on serving all the
requirements of the pharmaceutical, biotechnology and allied industries.
We have highly qualified validation personnel who have proven depth of IT
development and support experience, to help in the specialist requirements
of Computer Systems Validation and 21 CFR Part 11.
Allied
Research & Development
Allied Research & Development provides validation solutions for
FDA-regulated companies within the Pharmaceutical, Medical Device and
BioMedical industries. Our core expertise is in content management for 21
CFR Part 11 compliance and the software control of clinical trials. We
also provide computer validation, software quality assurance, protocol
development and training. Our Clinical Data Collector portal software
provides on-line control for human clinical trials with 21 CFR Part 11
compliance.
Amadeus International
Amadeus International alone offers you eQRP Management and eQRP Environment, standards conformance solutions developed specially for large businesses.
AMCS
AMCS offers FDA quality, compliance, training & validation, and integrated
engineering of hardware & software control systems to a variety of
industries, particularly in FDA regulated industries such as
pharmaceuticals, biologics, & medical devices. With our unique
capapbilities & talents, AMCS provides clients with a variety of practical
and effective 21 CFR 11 compliance solutions. AMCS becomes an extension of
clients' resources by providing the seamless addition of experienced
resources.
Analex
ISO 9001 certified (Denver and Cleveland locations) and a Microsoft
Certified Partner (Denver location). We are advanced software and systems
engineering firm providing software validation, software development,
design control, product design and development, and other critical
services supporting FDA-regulated companies. Services incorporate detailed
knowledge and experience with 21 CFR Part 11 and Part 820.
Anthares Group
Anthares Group is a consulting company strongly focused in the life
science market. Anthares Group is able to support the customer through all
the IT life cycle project, including Computer System Validation. Thanks to
the strong IT expertise within the company, Anthares Group can integrate
EDMS, MES, EBRS solution. The Group is able to support the customer from
the 21CFR11 Assessment to the Remediation, including modification of the
system, replacing or updating.
AppLabs Inc
AppLabs is a leading provider of testing and QA services to the
healthcare, pharma, and life sciences industries. We provide various
compliance services, including 21 CFR Part 11, as well as various software
certification services to meet regulatory requirements. As a specialist
firm in compliance testing, AppLabs is an ideal third party resource to
bring in to meet your compliance needs.
Applied Control Engineering
ACE is an independent control and information technology systems
integrator specializing in services for the regulated Biotech and
Pharmaceutical industries. 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.
Applied
Industrial Automation
Applied Industrial Automation is a Manufacturing Systems Integrator
headquartered in Charleston, South Carolina. . We work with our clients as
a partner to deliver systems that exceed expectations in improved
productivity, competitiveness and profitability. Our services include
Project Management, Automation Consultation, information and database
management, and control systems integration to meet the requirements of 21
CFR Part 11.
AQS Validation Group
AQS Validation Group is dedicated to provide the project management skills
to ensure timely Technical Support and Validation Systems including 21 CFR
Part 11 services for the most challenging manufacturing and regulatory
environments. Our extended range of services includes Computer
Validations, Microbiology Assessments, Process Performance Qualification,
Laboratory Test Method Validations, Statistical Technical Support to
Process Audits and Cleaning Validation Assessments, among others.
Arvin
Shroff Associates
Arvin Shroff Associates specializes in FDA regulatory, and compliance
issues. He serves as an advisor to pharmaceutical and biotechnology
companies, medical device and the biological industry in the following
areas: RSOP, failure investigation reports and third-party audit reports.
Assist in formulating a response to FDA pertaining to FD-483, Warning
Letter, AIPL and other similar communications from the agency. Assist in
drafting Corrective Action Plan, monitoring progress and accomplishment
for upper management. Provide post-enforcement recommendations, training
and Provide expert witness testimony, Deposition reviews and Consultation
during litigation.
Assero
Assero Limited is a dedicated business focused on the specialist
requirements of Computer Systems Validation and 21 CFR Part 11 for
companies deploying electronic data capture technology, in particular
electronic Patient Diaries, for use within clinical trials.
Automated
Systems
ASI was established in 1989 as a systems integration and full service
validation firm specializing in pharmaceutical, device, and biotech
applications. ASI has a wide range of abilities and a full time staff of
programmers and compliance experts to assist with the most challenging 21
CFR Part 11 requirements. ASI offers a wide array of Part 11 services. Our
consultants can inventory, assess, and provide a detailed gap analysis of
plant systems. Our programmers can provide robust and creative solutions
to remediate PLC, MMI, SCADA, and database systems. ASI has developed “Part
11 Armor” a software module designed to add robust audit trail
capabilities to most major MMI and SCADA packages. All ASI projects are
implemented with the greatest respect for client deadlines and budgets.
Automation
& Validation Solutions
AVS (Automation
& Validation Solutions) provides innovative solutions to the
Pharmaceutical, Biotechnology and Medical Device industries. We provide
our clients project leadership as partners to efficiently meet their
goals. AVS has expertise in 21 CFR Part 11 ER/ES Ruling interpretations
and electronic data applications as pertaining to Pharmaceutical, Biotech
and Medical Device industries' data acquisition, Electronic Batch Record,
Audit Trail, Closed and Open Systems. We provide expertise to perform
system inventory, evaluation and re-mediation to bring systems into
compliance with 21 CFR Part 11.
Barry-Wehmiller
Design Group
Over the last ten years, Barry-Wehmiller Design Group, Inc. has developed into one of the leading automation, engineering and validation companies in the U.S. with more than 170 professionals. Last year, BWDGI supplied over 90,000 engineering hours to serve our clients, which include seven of the top ten Pharmaceutical companies in the world. Design Group provides master plans, auditing, remediation and protocols for a wide range of computer and automated systems. Phone: (864) 486-4300
Blackbird Group
Business Consulting firm specializing in project management, quality
assurance & validation testing and business analysis for the
pharmaceutical and bio-tech industries. Plan and manage projects to
evaluate, validate and implement LIMS computer systems.
Bovis
Lend Lease Pharmaceutical
Bovis Lend Lease Pharmaceutical has over 10 years experience of regulatory
aspects of Computerized Systems within the Pharmaceutical and Healthcare
industries. BLLP has managed Y2K and Part 11 projects site-wide and
globally
since 1997 and provides professional consulting services on all aspects of
Part 11 and adherence to GxP guidelines for computer validation.
Brock
Solutions
Brock Solutions (formerly Picard Technologies) is a premier service
provider using the full range of our capabilities - in Validation,
Automation Engineering, Systems Integration, Technical Transfers,
Equipment Management, and Consulting - to implement the solutions you
need. Our industry-proven project methodologies based on GAMP and ISPE
fundamentals, bring clients reliable service on time, on budget. With our
integrated approach to customer service, the 220 employees of Brock
Solutions can deliver complete solutions to meet your needs for full
service pharmaceutical project management and integration.
CDI
Engineering Group
CDI Engineering Group is a leader in providing validation services for the
biotech and pharmaceutical industries. We have specific expertise in 21
CFR Part 11. The CDI team provides validation expertise for regulatory
compliance on computerized systems, software development methodologies and
information technology network infrastructure qualifications. We also
provide a wide range of integrated engineering services.
Centient Consulting, Inc.
Centient Consulting is a professional services firm specializing in the
business, science and technology needs of the biotechnology and
pharmaceutical industry. Our Compliance Practice focuses specifically on
Part 11 and GxP compliance and validation. We have worked with Genentech,
Bristol-Myers Squibb, Schering-Plough and others to apply 21 CFR Part 11
inventory, assessment and remediation strategies to both new technologies
and legacy systems.
Cetan
Technologies
Cetan Technologies, Inc. provides specialized computer system validation (CSV)
services for the pharmaceutical, biotechnology, and medical device
industries that help meet regulatory compliance requirements and supply
quality assurance peace of mind. We have assembled a highly effective CSV
team composed of knowledgeable industry professionals. Our CSV teams
continues to earn its worldwide reputation for customer satisfaction
through years of computer system validation of a large variety of systems
using its practical, time-tested, and defensible approach to CSV to
determine whether it performs its intended functions accurately and
reliably.
Chief Security Officers
Chief Security Officers, Inc. mission is to assess your company's IT
security challenges, identify solutions to your specific problems, and
work with you to implement the solutions and achieve the desired results.
They have worked on numerous technical projects that required compliance
or guidance under the following standards: Sarbanes-Oxley, Gramm Leach
Bliley, HIPAA, CFR 21 Part 11, ISO 17799, and CobiT.
CIMCON
Software
CIMCON Software, Inc. offers a suite of 21 CFR 11 products and services
that integrate e-technology and compliance in life sciences. CSI's
einfotree™ Digital Compliance™ solution is the
industry's first remediation tool that integrates both file and database
management systems into a regulated, controlled and fully compliant
digital nervous system.
CimQuest
CimQuest is an industry-recognized leader in providing Computer Validation
and Quality Support Services for the FDA-regulated industries. CimQuest
has partnered with many of our Biotechnology and Pharmaceutical clients to
assist them in determining their level of compliance to the 21 CFR Part 11
rule.
Cipricorp Technologies Inc.
Provides staffing, consultants, consulting, project management and other services to regulated industries. 21 CFR Part 11, HIPAA, SARBOX, OSHA and more. High availability system architecture.
CISYS
A "Tech Fast 50" award winner, CISYS is a leading
technology firm providing compliance, consulting, and software solutions
for the pharmaceutical, biotech, CRO, and healthcare industries. Out of
RTP, NC's Biotech hub, Cisys delivers systems & expertise on
compliance (21-CFR Part 11, HIPAA, CSV), GxP practices (audit and
compliance), network wireless, (EDC) & security solutions. Our
consulting team leverages extensive knowledge of life sciences &
technology, to meet business & technology goals.
Clarkston
Clarkston has been providing system validation since 1997 when the FDA
issued 21CFR Part 11. From FDA compliant enterprise systems to electronic
signature capture to web-enabled Clinical Registration Forms, we help
ensure system compliance for your organization at every turn. Our
common-sense approach, well-developed SOPs and Life Cycle methodology
facilitates system-wide validation without expending additional resources.
CLINICALSOFT LLC
ClinicalSoft provides full and incremental validation services for
Clinical and Safety Data Management Systems. Our clients include large
pharmaceutical companies, CROs and biotech companies. Our extensive
product knowledge, industry experience and understanding of regulatory
requirements enable us to provide superior validation consulting services.
CMI
Consulting
CMI offers expert consulting on the process and requirements involved in
this standard, minimizing adoption cost and leading you to a successful
validation process. Our expertise focuses on your industry. Our unique
solution includes full-range compliance services, enabling your validation
to this broad and stringent act.
Coda
Corp USA
Coda Corp USA is a consulting company providing regulatory compliance
services to companies subject to Title 21. Coda Corp USA principals have
been involved in compliance activities for over 10 years each with a
strong focus on software development and validation. Coda Corp USA has
provided services to many industry leaders, both on local and global
levels. Corporate overview, project, personnel and reference information
is available upon request.
Code
Refinery
Code Refinery provides software validation and custom software development
services to the pharmaceutical, life sciences, biotech and FDA regulated
markets. Using established software documentation tools and industry
accepted best-practices, Code Refinery can help you navigate the entire
software development life cycle. Whether it's software design, development
or testing, Code Refinery works with clients from the beginning to ensure
that the entire life cycle is followed and documented.
Compliance Associates Inc.
At Compliance Associates, we deliver services that are anchored in both experience and standard methodologies. Compliance Associates Service Solutions Model gives you the freedom to choose only the services you need. We help our customers develop the road to compliance while leveraging current operating technologies and business processes. Our services include Technology Solutions, Electronic Submission Solutions, as well as Regulatory and Compliance Solutions and Products.
Compliance
Line
A 24-hour toll-free telephonic answering, reporting and tracking of
compliance concerns to assist in the identification of possible unethical,
illegal or questionable behavior and to fulfill compliance program
requirements.
Compliant by Design
Compliant by Design provides compliance and validation services to small
to mid-sized companies within the pharmeceutical community. We offer a
full range of services from complete system design and implementation to
21 CFR Part 11 compliance collaboration. See our web site for a more
comprehensive view of our services.
Computer
Compliance
Computer Compliance, Inc. is a consulting firm specializing in the cGMP
validation of computer-related manufacturing equipment and process
systems. We focus on providing a higher level of service and value for
FDA-regulated companies within the Pharmaceutical, Biotechnology, and
Medical Device manufacturing industries.
Computer System Validation
David Nettleton is a Computer System Validation Specialist and project
management consultant involved with the development, purchase,
installation, operation and maintenance of computerized systems used in
regulated applications (21 CFR part 11). Services include gap analysis,
remediation plans, SOPs, vendor audits, and training. David has completed
more than 117 software validation projects including; blood bank, clinical
trial, document control, Excel spreadsheets, LIMS, ERP, and toxicology.
Computer
Task Group
For over 36 years CTG's ISO-9001 certified offices has delivered IT
staffing, application management, and D&I services to Global 2000
customers. Our hands-on expertise allows clients to focus on their
business while using IT to gain a competitive advantage. CTG brings a
solid background of experience in the pharmaceutical industry, focused on
QA & Validation. Our methodology has been used to support FDA
regulatory requirements for validation, including 21CFR11 for clients;
Lilly, J&J & Pharmacia.
Control Quest Inc.
Compliance Master web based software application. Compliance Master is the
most comprehensive Software Tool for all your Compliance needs.
Critical Computer Validation Mistakes
Avoid Costly Errors -- immediate Part 11 Guidance is available through the
new book, "Computer Validation: The 100 Worst Mistakes You Can Make".
Includes numerous Case Studies & FD-483s along with Corrective Actions.
Provides faster, easier ways of tackling such monumental problems as
Insufficient Testing on Existing Validations, Non-Compliant Legacy
Systems, etc. Offers great time-saving shortcuts that save you money while
ensuring the compliance of your validation effort. See website.
CSSC
CSSC, Inc. is an established, full-service validation and regulatory
compliance firm serving the pharmaceutical, medical device, and
biotechnology industries. Our dedicated staff of 21 CFR Part 11 experts
are recognized and respected throughout the industry, and they have
traveled around the world performing comprehensive Part 11 compliance
assessments, remediation, consulting, and training.
Cyber
Conseil
CyberConseil has offices in Paris, Brussels and Lyon. Our main skill is
COMPLIANCE AND VALIDATION. CyberConseil brings you a concrete assistance
to evaluate, optimize and ensure the compliance of your systems,
respecting regulatory requirements : GxP FDA, EMEA... CyberConseil is
specialized in 21 CFR Part 11 compliance since 1997, and has structured
his methodology with computerized tools. CyberConseil is able to validate
all your systems, software, processes, equipments, and utilities with a
total independence.
CyberVal
CyberVal Pharma specializes in offering valuable solutions to meet complex
pharmaceutical laboratory requirements. Integration and validation of
hybrid chromatographic hardware and data systems equipment. Comprehensive
instrument Service Contracts that maintain system compliance in a GxP,
21CFR Part11 regulated environment. CyberVal Pharma provides unique
laboratory computerized network expertise for chromatography client/server
upgrades from Windows NT to Windows 2000 platforms.
Darwin
Partners
Darwin Partners is a project-based
technology consulting organization focused on delivering solutions to
Pharmaceutical clients across their Research and Development, Sales and
Marketing and Manufacturing organizations. With a particular focus in the
FDA regulatory compliance area, we have successfully delivered assessment,
remediation, and validation services to both the clinical and
manufacturing areas. Our offerings are designed to address discovery,
clinical, and manufacturing environments with regard to 21 CFR Part 11.
DHI
Books
Straight-forward guidance on 21 CFR Part11 can be difficult to locate,
and small issues misunderstood can be time-consuming and very costly. Our
desktop guides are designed to alleviate the nitty gritty issues, such as
electronic records and signatures, auditing, legacy systems, testing,
planning and reporting.
Digital
Applications International
Digital Applications International (DAI) DAI's has worked in the CSV arena
since 1995 supporting some of the leading global companies in the
Pharmaceutical, Specialty Chemicals, Food & Drink and CPG sectors. DAI
focuses on ensuring that the computerized systems and the policies and
procedures conform to the relevant GxPs. DAI's solutions in this area
include validation planning and policy development together with
retrospective, concurrent and prospective systems validation including 21
CFR part 11 issues. DAI is an ISO 9001 and ISO 9000-3 (TickIT)
organization.
Digital Consulting
& Software Services
Digital Consulting & Software Services, Inc. (DCSS) is a full-service
consulting firm and technology strategist for the regulated industries,
providing a unique balance of individuals with experience in regulatory
compliance and information technology. DCSS has formed two distinctly
separate business units, Computer System Validation (CSV) Services and
LIMS Consulting Services, to address the issues of developing,
maintaining, and securing a controlled system environment.
Domain
Systems
We are a company of consultants that are passionate about technology and
obsess with customer service. We provide intelligent validation solutions
for FDA-regulated companies within the Pharmaceutical, Medical Device and
other life sciences industries. With core expertise in Documentum, Agile,
MatrixOne and other content management technologies, Domain Systems,
assures 21 CFR Part 11 compliance. From offices in Salt Lake City, Detroit
and London, Domain Systems can empower you with a competitive advantage.
Drumbeat
Dimensions
Drumbeat Dimensions Inc. (DBD) is a professional compliance management
company dedicated to developing products and tools that enable our clients
to achieve worldwide compliance efficiently. DRUMBEAT® based
tools for assessing, enhancing, and maintaining regulatory compliance and
reducing regulatory vulnerabilities are based on the analysis of
contemporary world-wide regulations, standards, and practices in GXP (GMP,
GCP, GLP) regulated industries.
Dunn
Solutions Group
Dunn Solutions Group provides a wide range of software consulting services
to the Pharmaceutical industry and has a deep understanding of the
regulations the FDA imposes on technology solutions. We have experience in
building new systems that are compliant as well as upgrading existing
systems to bring them into compliance. Most recently, we developed and
validated a 21 CFR Part 11 compliant system at a major pharmaceutical
client with great success. Leverage our experience and ability to deliver
to assist with new information technology initiatives in your
organization.
Ecora
Software
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.
IDEC Validation Limited
A provider of Quality and Compliance services primarily in the CSV field. Able to assist organisations satisfy their immediate Regulatory and Compliance requirements by providing fully conversant industry experienced staff. IVL has extensive field knowledge; this is reflected in their professional approach, application and implementation of compliance solutions. IDEC Validation Ltd is determined to provide a quality service to our customers, whilst passing on the advantages of cost that a medium sized company with strict internal controls can provide.
Info@eduquest.net
EduQuest's areas of expertise include the validation of regulated computer
systems, requirements for electronic records and electronic signatures,
process control and validation, quality systems, internal auditing,
regulatory compliance and enforcement, and the full range of "GxP" (i.e.,
good manufacturing, good laboratory, and good clinical practice)
requirements.
EHK
EHK, founded by a former FDA Field Investigator, is a worldwide compliance
consulting service with considerable direct FDA knowledge and experience.
Our experts, each with at least 10 years of industry experience, provide
practical expertise and advice to the pharmaceutical, medical device,
biologics, biotechnology, and affiliated industries. We offer in-depth
assistance in determining and achieving compliance with FDA regulations
and expectations with respect to Good Manufacturing Practices, Good
Laboratory Practices, and Good Clinical Practices.
Enmed
Enmed's Endorse™ is a comprehensive service that helps
organizations obtain regulatory compliance for data management systems and
processes. Endorse enables your organization to achieve regulatory
compliance with all FDA guidelines governing computer system
record-keeping, including 21CFR Part 11, GMP, GLP, GCP and QSR. Endorse
services include computer system validation, gap analysis, code
remediation, process development and comprehensive training.
Epitome
Technologies
Epitome Technologies is an India based solution company providing
Validation and Automation solutions for Pharmaceuticals Industry. Epitome
Technologies can take care of compliance requirements starting from
creating master validation plan, creating DQ, IQ and OQ as well as
implementing the same. Being an Indian company it offers obvious cost
advantage while maintaining the professionalism and quality as per world
standards.
eRT
eRT is a solutions provider to the clinical research industry offering
regulatory compliance consulting, not only on our software products but
also on third party software and systems validation.
European
Pharmaceutical Group
The European Pharmaceutical Group (EPG) is an autonomous organization
within Mi Services Group, an international E-business systems' integrator.
The EPG has extensive experience and knowledge of GxP regulations within
manufacturing, clinical and laboratory domains. A range of consultancy
services are offered including; compliance, training, software and
infrastructure validation and project management, 21 CFR Part 11
assessments, supplier and software Quality System audits and user
requirements' definition, based on business process analysis and
optimization.
Excalibur
Consulting
Excalibur provides consulting services for Pharmaceutical and Medical
Device Companies. The company specializes in Computer System Validation
Services, 21CFR Part 11 Compliance Reviews, Project Management, Document
Management, Supply Chain Management, Bar Code Technology, and eProcurement
systems
Exygen Research
Exygen Research supports all phases of the drug development process. This
includes dedicated personnel and equipment for rapid method development
and analysis in support of drug discovery, GLP-compliant bioanalytical
support for preclinical and clinical development, cGMP-compliant method
development validation, and stability and release testing on drug and drug
products.
Generic
Based in the UK, Generic has ISO 9002 and TickIT accreditation. We draw
upon the skills of consultants with 21 CFR Part 11, Validation, LIMS and
GxP expertise to provide bespoke solutions. Each is experienced in CSV,
GxP, LIMS, QA with knowledge of industry regulations and association to
regulatory bodies. We offer them individually or for a complete managed
project solution. We have worked on validation projects for many of the
global top tier pharmaceuticals and bio technology companies
Genesis
Solutions
The enterprise asset management practice at Genesis Solutions includes a
robust implementation and validation service offering for plant
maintenance systems. Specifically, we help our clients in the
pharmaceutical and related industries deal with compliance issues around
21 CFR part 11. We support Maximo, Datastream's 7i, SAP PM, and other CMMS
products.
Glemser
Technologies
Glemser Technologies Corporation provides comprehensive validation
services to FDA regulated companies. Glemser can help your organization
validate new systems prior to production use or retrospectively validate
existing systems. Our experienced professionals specialize in a wide range
of validation activities including validation planning, 21 CFR Part 11
compliance assessments and remediation plans, protocol development, test
script writing and execution, final report documentation, SOP development,
post-validation audits, supplier audits, and validation training.
GxPJobs.com
GxPJobs.com is an exciting job search service targetting professionals
working in the life science industry covering Management, Sales,
Technical, IT, Regulatory Affairs, Validation, Compliance, QA, QC and
Administration staff
Health
Data Services.
Health Data Services is a compliance and validation consulting company
servicing healthcare products' manufacturers and healthcare delivery
providers. Formed in 1993, HDS is at the forefront of offering
unique solutions where compliance and technology come together.
HSB
Reliability Technologies
HSB Reliability Technologies helps clients improve profitability, by
reducing manufacturing costs, and increasing production through
implementation of reliability solutions for the Refining, Petrochemical,
Chemical, Pulp & Paper, Food, Mining, Power, Pipeline, and Metal
Processing Industries. Services are delivered through World-Class
Reliability™ Benchmarking, CMMS Assist™, and
Total Plant Reliability® (TPR) Solutions.
IBM
IBM provides a variety of Validation consultancy services, some
independent of method and some integrated around the SUMMIT Ascendant
Validation method. A SUMMIT Ascendant Center of Excellence in the US or UK
can help direct such inquiries.
IDE
Consultants
ICI's focus is Electronic Document Management. Located in the Mid-Atlantic
Region, US, ICI serves Pharmaceutical and Biotechnical customers on the
U.S. East Coast. We provide implementation and validation for: *
Electronic Document Management and Knowledge Management Solutions *
Document Content Management Solutions * Records Management Solutions, and,
* Absolute Document and Intellectual Property Security.
INFO@INTERPRISEPR.NET
Computer Security Software and Consultants; Electronic Document Management
Systems; Scientific Data Management Software; Software Vendors and Systems
Integrators; Design & Development of Custom IT Solutions that meet terms
of FDA Regulation 21 CFR Part11. Software Validation Protocols,
Implementation, GxP. PHONE 787-449-1349.
The Integra Partnership
Integra provides a specialised range of quality and compliance-related
services to the healthcare industries. We help our clients manage their
compliance risk in a cost effective manner. Integra is different. We
provide the highest quality of services, expected from the ‘Big 5’
consulting firms, at a cost normally associated with contract resources.
Integrated Validation Services
Integrated Validation Services, Inc. is a BioPharmaceutical service
company providing validation services nationally and internationally. We
specialize in providing an integrated, flexible approach to best serve our
client's needs. Our validation services include 21CFR Part 11 Computer
Validation, PLC, DCS, LIMS, Databases, Auditing, Training, Remediation,
Equipment Validation/Cleaning, IQ, OQ, PQ, Master Plans, SOP's, Quality
Assurance, GMP Audits, and Program/Project Management.
Integrated Validation Solutions
21 CFR Part 11 Computer Validation, PLC, DCS, LIMS, Databases, Auditing,
Training, Remediation, Equipment Validation /Cleaning, IQ, OQ,PQ, Master
Plans, SOP's.
Integrity
Group
The Integrity Group performs 21 CFR 11 gap analysis, process
reengineering, documentation, validation, and implementation of compliant
systems at reasonable rates. FDA inspectors recently called our validation
of a large computer system a "benchmark" by which to measure
other validations.
Integrity
Solutions
ISL provides Quality and Compliance services that are tailored to specific
customer needs. Whether your problems are management, skills, systems or
resource related, we can help. Our experience covers Computerised Control,
I.T., Engineering, Q.A. and Laboratories. Our services include
Organisational Change, Skills Development, Quality Systems Implementation,
Quality and Compliance Auditing, Validation Planning and Delivery, ERES
and IT Infrastructure Compliance.
International Network Services (INS)
21 CFR PART 11 COMPLIANCE- INS provides the opportunity to assess your
ability to develop a plan that identifies gaps, designs a technical and
procedural solution, and implement/optimize it to meet business and
financial requirements. We provide on-site coordination with executive
staff and security officers to develop the best solution.
•Assessment
•Architecture
•Authentication and Access
•Infrastructure
•Policy and Procedure
•Operations program
•Awareness
IPR International LLC
It’s not about backing up your data-it’s about RECOVERING it when you
need to. If you are required to maintain records for many years, the
chances of being able to comply diminish using a tape backup or
archiving system. IPR International offers a comprehensive suite of
solutions designed to provide immediate, online data backup, archiving
and recovery, with reliability and security built around the continuous
availability of data from any location in the world, on a twenty-four
hour basis.
I-SYS
RSI
Established is 1991, I-SYS is a
leader in software validation and Part 11 remediation and solutions. With
hundreds of projects completed world wide and offices in the US, Europe
and Asia, we provide a true global coverage. Our perfect performance
record allows us to provide a unique industry warranty that has never been
challenged by a regulatory authority or any of our customers. The I-SYS
Risk Based approach and unique industry warranty provide the best
available business solution.
IT&E
IT&E has been assessing, advising and designing comprehensive systems
solutions in the Pharmaceutical, Biotech, Engineering and IT industries
since 1996. IT&E’s sole purpose is to bring projects to completion within
the timelines and budgetary guidelines of our clients, while delivering
superior quality. IT&E has a full complement of deliverables, processes
and procedures as it relates to FDA regulations, all of which meet or
exceed FDA regulations.
ITC
Validation Consultants
ITC Validation Consultants provides validation consultancy for
organizations seeking regulatory compliance on computerized systems and IT
network infrastructures. We are used to working to international
regulatory requirements throughout the development lifecycle. We are
experienced in validating ERP, LIMS and SDMS systems and qualifying IT
infrastructures to be compliant to international GxP's including 21CFR 11
across those GxP's.
JASA
Consulting Group
The JASA CONSULTING GROUP provides an interdisciplinary approach to
assisting industries regulated by FDA and international medicinal health
agencies. The mission is to only offer the very best services in the most
cost effective way while providing an accurate interpretation of the
regulations, directing regulatory and compliance strategies, preparing and
reviewing regulatory submissions, advising and implementing 21 CFR Part 11
compliance programs, electronic submissions and audits, performing GMP,
QSR, GLP, and GCP audits, and delivering tailored interactive training
seminars to our clients.
Johnson Controls, Inc.
Johnson Controls comprehensive Validation Support Services enable regulated facilities to be compliant throughout the design, construction, operation, and management phases of their life cycle. The program includes a best-in-class validation planning methodology and implementation processes proven over more than a decade of work in the Life Sciences. Our approach involves technology, procedures and regulatory code interpretation delivering engineering excellence and precise documentation detail.
Kevin
Technologies
Kevin Technologies Pvt Ltd, and India based company, provides Controls
Systems Integration, GMP validation and IT solutions to companies in the
Pharmaceutical, Biotech and other process industries. Our expertise in
these core areas enables us to provide effective solutions for 21CFR Part
11 compliance (Electronic Records/Signatures). We also undertake complete
Validation Services including Master Validation Plan Development,
Equipment Qualification & Facilities Qualification.
Kforce Health Technology
We are a specialty division of Kforce Professional Staffing focused on
providing validation professionals to Life Science based companies. Our
focus is on biotech, pharmaceutical and medical device companies
searching for validation staff augmentation, project management and core
employees. We specialize in all types of validation support for 21 CFR
part 11, process, equipment, automation, test equipment and facilities.
Please email for more information and consultation.
KMI
KMI is a leading consulting firm providing GMP compliance and validation
services to the worldwide pharmaceutical, biotechnology, and medical
device industries. KMI's IT Consulting Services group has a proven 21 CFR
Part 11 assessment/remediation methodology that has been used on small and
large client projects. The Part 11 methodology coupled with the KMI Legacy
System and Computer Validation methodologies provide a complete Part 11
compliance solution.
Labelle
& Associates
LaBelle & Associates, Inc. delivers a full spectrum of validation and
compliance services to the pharmaceutical, biotechnology and medical
device industries around the world. With over twenty years of experience,
and an understanding of the most current regulations and interpretations
(e.g., 21CFR Part 11), we are able to provide an accurate, objective,
third-party view of your compliance status and needs. LaBelle &
Associates, Inc. ensures up-to-date compliance at any stage of the product
life cycle and provides consulting and audit services covering cGMP, GLP,
GCP and HS&E.
Laboratory Systems Consulting
Laboraory Systems Consulting is a BioPharmaceutical & Life Sciences
service organisation specialising in Quality and Compliance Information
Management systems and services around LIMS, CDMS, 21CFR Part 11
Computer Validation, CAPA, ERP Integration, Validation Services, Master
Plans, SOP's, Quality Assurance, IT & Vendor Audits and Program/Project
Management and oversight.
Laboratory
Validation & Services
LVS provides validation services for standard/custom COMPUTER SOFTWARE
(Data Acquisition Systems, Complaint Databases, Pharmacokinetic Analysis,
Inventory management…), AUTOMATED SAMPLE PREPARATION SYSTEMS (Zymark
& Tecan robotics…), LABORATORY EQUIPMENT (LC/GC systems…), MEDICAL
DEVICE (21 CFR 820 SDLC), and 21 CFR PART 11 evaluation. Document
evaluation/creation for User Requirements, Design Specifications, and
SOPs. Our clients include major pharmaceutical & Biotech companies
worldwide.
Life Science Services
LSSI serves the pharma, biotech, and medical device industries. Services
include Project Management; Computer System Validation (CSV); 21 CFR Part
11 validation; evaluation and remediation of legacy systems; GxP, GERM,
and GAMP compliance auditing; validation master planning; validation
certification documentation; SOP development and remediation; document
management systems; change control systems; and validation education and
training including web and computer based training (WBT/CBT). We proudly
serve a global clientel.
Lumina
Engineering
Lumina Engineering provides medical device manufacturers and other
biomedical companies quality assurance and validation services that assist
in the comprehension and compliance with FDA regulation. We offer
expertise in validation and gap analysis for 21 CFR Part 11. Other FDA
regulatory affairs services include: submissions, compliance auditing,
enforcement and procedure writing.
McDowell
Group
We specialize in providing contract and permanent support for FDA
regulatory projects - to end users and other FDA service providers who
need assistance staffing projects. If you need Computer Systems Validation
specialists for Part 11 assessment or engineers to perform cGMP validation
or corrective action, McDowell Group is a very cost-effective source for
this support. And we will find you multiple qualified candidates in a
remarkably short period of time.
Medical Software
Medical Software provides quality software solutions to FDA Regulated
companies. We command a thorough understanding of federal regulations and
industry standards from more than 15 years of hand on experience. We have
extensive experience with Part 11 including training, application
selection, gap analysis, remediation, mitigation, SOPs, and data center
infrastructure. We have implemented several solutions for customers. It
takes much more than an application to resolve a part 11 gap. "In God we
trust, we others we Test."
META Solutions
META Solutions offers comprehensive, technology-based consultation and
management services. Our thorough understanding of regulatory
requirements, quality assurance, data management and systems development
and validation means that we possess the necessary expertise to help
you. Our Advanced Technology Services include: Regulatory Consulting,
Computer Systems Validation, Clinical Data Management, Document
Management, and Information Technology Services.
Mi Services Group
Mi Services are a global company, specializing in IT solutions for the
Life Sciences industries. With a dedicated Life Sciences team, the company
has extensive experience and knowledge of GxP regulations within
manufacturing, R&D, clinical trials and corporate systems in
pharmaceuticals, biologicals and medical devices. The company has a well
established 21 CFR Part 11 assessment framework, with a linked remediation
methodology, allowing cost, compliance and GxP risk to be considered in a
consistent and rational manner. The company has conducted literally
thousands of system assessments and have had programmes reviewed by the
FDA as part of site Inspections. Using their 'GxP eleven' framework, the
company specializes in the assessment of ERP systems such as SAP R/3 and
Oracle 11i as well as other mission critical systems such as LIMS, MES and
EDMS.
Mintanciyan
Consulting
Mintanciyan Consulting, Inc (MCi) is a leading provider of Validation
Services for the pharmaceutical, biotechnology and medical device
industries regulated by cGxP standards. Our core expertise is focused on
Computer Systems Validation, including: * IT (ERP, LIMS, EDMS, LAN) *
AUTOMATION (PLC, DCS, Building Automation) * 21CFR Part 11 (Assessment and
Remediation) Our practical and cost-effective service will assist you to
implement Validation Programs in a timely manner, and to comply with all
the necessary regulatory controls and standards within your type of
business. MCi, headquartered in New York with offices in Puerto Rico and
Ireland, is ready to assist you on a global basis, based on its proven
track record of quality services to industry leading companies.
MSI
MSI provides reliable and cost-effective 21 CFR Part 11 services for IT
systems and process/motion control equipment. From assessments to
installing software and equipment, we ensure you meet the FDA's goals of
minimizing data falsification and maximizing data security. At MSI, we
don't just propose, we execute!
New Age Sys
NewAgeSys, Inc. provides Computer System Validation and Custom Software
Development Services to Fortune 500 Pharmaceutical and Biotechnology
companies. We serve three of the top 10 and many Fortune 100 companies. We
provide solutions to help companies address 21 CFR Part 11 issues and move
more quickly toward compliance. This includes strategy and planning
services, strategy review, systems and process audits, application
remediation, and program management services. We serve three of the top 10
and many Fortune 100 Pharmaceutical and Biotechnology companies.
Newton Solutions
Management consulting company with a history of successful global
implementations in the pharmaceutical arena.
NutriCeutical
Consulting
NutriCeutical Consulting provides validation and regulatory products and
services to the Food, Pharmaceutical, Medical Device, and Biotech
industries. In addition, we work with equipment suppliers during the
design phase to assure their products can meet regulatory requirements.
Our products will assist you in complying with the most stringent, and
latest regulations. We supply Installation Qualification (IQ), Operational
Qualification (OQ), and Performance Qualification (PQ) validation
documents for virtually any process or equipment; we can even execute
these documents at your discretion. In summary, we create the validation
documents required in regulated industries.
OSR Solutions
“OSR Solutions strongly believes that Part 11 Compliance should not be a
series of point solutions only addressing regulatory risk but is a
significant opportunity for business transformation to streamline
Operations through enabling technology”
We have the knowledge, tools techniques, experience and resources to
accelerate your drive towards compliance.
Experienced Resources
Dedicated Compliance Staff
Validation Expertise
Comprehensive training
Onsphere
OnSphere's Pharmaceutical Practice provides software development expertise
and extensive industry experience to our clients in the pharmaceutical
industry. We have been very successful developing software that reduces
our clients' time-to-market for new pharmaceutical products while adhering
to the stringent guidelines mandated by the FDA. OnSphere fully
understands that software used in the pharmaceutical industry is subject
to the rigors of validation as well as to the administrative practices and
tools commonly required in pharmaceutical applications.
PENSA
Technology Solutions
PENSA Technology Solutions Inc. offers a knowledgeable and experienced
staff to aid your regulatory company in practical computer related
validation. With software tools built from scratch to conform with 21 CFR
Part 11, PENSA ensures that you will be delighted with the speed and ease
with which we can present you with a complete validation package of your
laboratory equipment, your process or your product. With the same
proficiency we can validate your LIMS, DMS, ERPS or MES.
Pharmaceutical
Services
Pharmaceutical Services Corporation validation consulting company
specializing in the validation of computerized systems. We are based in
California and have direct experience with Oracle, Allen Bradley,
Millennium32, HP Chemstation, Access databases and Excel Spreadsheets.
PharmTech
PharmTech is a validation and compliance services company committed to
delivering the best value and the highest quality service to our
pharmaceutical, biotechnology, and medical device industry clients. Our
staff of seasoned professionals offer client organizations a single-source
solution for supporting all of their regulatory compliance needs with
expertise in: Part 11, GMP, GLP, GCP, and QSR regulations.
Phoenix
Consulting
Phoenic Consulting offers quality and compliance consulting for FDA
regulated Biotech, Medical Device and Pharmaceuticals. Led by an attorney
and software developer of 20 years experience, we integrate regulatory
interpretation and practical validation skills. Validation and Part 11
planning, assessment, gap analysis, remediation, including, protocols,
traceability, reports and custom documents.
PMK Pharma
Consulting
Our Group in Germany provides a wide range of software consulting services
to the GXP regulated industry. We have experience in generating Validation
Master Plans (VMP) for different systems. We developed checklists to
analyze compliance with 21 CFR Part 11 and other predicate rules as well
SOPs for the corresponding processes (LIMS, GAMP/GALP systems, Clinical
Trials, EDC etc.). We also perform audits.
PredatorWatch, Inc.
To Comply with 21 CFR Part 11 requires that you take proactive steps, known as “Due Care” to ensure confidentiality and non-repudiation of sensitive data. Risk of being out of compliance by being vulnerable to hackers or insiders with malicious intent is called Common Vulnerabilities and Exposures (CVEs).
The CVE Auditor™ 2.0 for 21 CR Part 11 Compliance will help you to ensure compliance, protect assets and reduce risks.
Princeton Center
Princeton Center (PC) offers pharmaceutical companies, their suppliers,
and consultants a process to create a consistent set of knowledge transfer
materials (such as WBT, Elec. Reference, Manuals, Job-aids, ILT, &
Testing,). Using PC's Knowledge Transfer System, companies capture SOP's
and GxP's in a structured way and immediately generate any materials they
need. With PC's validated method, production time is greatly reduced,
consistency guaranteed, and updates easily handled.
PSC
PSC is a search firm that has been in business since 1989. We will locate
the talent you need, whether on a contract basis or for "direct
hire." We specialize in placement for IT, Sales, and FDA Regulated
Industries.
PTI
International
PTI International targets performance improvement for professionals in the
pharmaceutical, biotech and medical device industries. Our continuing
education experience will provide you will the skill base needed to excel
in today’s workplace.
QA Edge, Inc.
QA Edge, Inc. provides computer validation, project management, software testing, and system documentation services as well as training to FDA-related firms. Also provided are validation services to software vendors servicing these industries. QA Edge offers a complimentary, one-day training session on Computer Validation and 21 CFR Part 11.
QAtor
QAtor is an international market leading provider of consulting services
and compliance management applications for the Life Science industry.
QAtor has developed the FDA regulated industries' first web-based fully
integrated compliance management framework for managing BOTH individual
documents AND content across multiple documents simultaneously.
QS Labs, Inc.
QS Labs, Inc. is improving business performance, reducing compliance and
product liability risks by providing on-demand solutions for life
sciences companies. Our suite includes compliance process, content, and
learning management platforms designed to systemize and simplify
regulatory compliance processes through validation driven development.
Visit our website or call 949 862 5000 to find out how QS Labs solution
is beyond compliance by integrating people, process, and performance.
QualityWare
QualityWare Inc. (QWI) specializes in providing computer validation and
FDA GxP/Quality System Regulation (including 21CFR11) compliance
assistance to medical device and pharmaceutical manufacturers, blood
banks, and the end-users of those systems and products. QWI is a Woman
Business Enterprise that successfully services clients in the US and
abroad.
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.
Quintiles Consulting
Quintiles Consulting provides global regulatory, compliance and validation
consulting to the pharmaceutical, biologic and medical device industries.
Our Software Compliance Services offer a wide range of software consulting
services covering regulated products and manufacturing processes, from
auditing and remediation to development and validation. Our unique blend
of former regulatory and industry expertise combines an FDA perspective
with the extensive "hands-on" experience of former industry
professionals. We are expert-led and results driven, allowing clients to
meet their regulatory requirements while achieving their commercial
objectives.
R.Dorsey+Company Information
Technology Solutions
IT consulting, including network management, security and design, risk
and system assessment, disaster recovery, contingency planning,
compliance consulting and many other information technology services.
Ramjet
Solutions.
Ramjet Solutions provides fast, efficient, scalable, maintainable and
affordable technical solutions and resources. We have comprehensive
experience providing technical analysis, design, development, testing and
validation of solutions to the pharmaceutical industry, including helping
our clients adhere to 21 CFR Part 11 guidelines.
RCM
Solutions
RCM Solutions, Quality & Compliance Services, offers technical
expertise to clients in the pharmaceutical and related industries. We
offer solutions to meet your tactical business needs in the areas of
computer system validation, regulatory compliance, electronic records,
regulatory risk assessment, gap analysis, vendor audits and SOP
development. RCM approaches each assignment individually to meet client
requirements.
R
D McDowall
Services Offered:
-
Computerized system validation of
analytical laboratory systems, chromatography data systems and LIMS
-
Assessment of systems and
software for compliance to 21 CFR 11
requirements and planning remedial actions
-
Data migration and system
retirement
-
Audits of Information Technology
Departments for compliance to
applicable regulations and 21 CFR 11
Dr Bob McDowall
73 Murray Avenue
Bromley, Kent BR1 3DJ, UK
Phone and fax +44-(0)20-8313-0934
Rockwell Automation/Propack Data
Rockwell Automation’s Regulatory Compliance Services (RCS) offers
comprehensive services for customers in pharmaceutical, biotechnology, CPG,
food and beverage industries for achieving and maintaining regulatory
compliance in all areas of the product life cycle, as e.g. development,
clinical studies, laboratory, manufacturing, and distribution deploying
all types of computerized systems.
RoseTECH
Consulting, Inc.
RoseTECH Consulting offers technical expertise to high-technology
companies (pharmaceutical, agricultural, environmental, specialty
chemicals). Services include: Technical Writing, Quality Assurance and
Regulatory Compliance, Technical/Regulatory Training, and Customize
Database Development.
Rusco
Located in the Philadelphia region, we are a full-service systems
integrator that also provides regulatory compliance services to help
clients balance schedule and functionality with cost and compliance
issues to achieve business goals. Our pharmaceutical experience
includes project implementation services to large companies in the
areas of parenteral drug, medical devices, and consumer products
manufacturing and their related compliance issues.
RVSI
RVSI offers the latest advancements in optical character verification (OCV)
systems for pharmaceutical label verification. Visionscape® I-Pak®
provides OCV; bar code and 2-D symbol reading; and label placement
inspection capabilities. Visionscape I-Pak builds and expands on the
highly regarded I-Pak series, including the I-Pak/Classic and I-Pak/ID,
and is FDA 21 CFR Part 11 compliant.
SEC
Associates
SEC is a leading provider of Regulatory Compliance Consulting and Computer
Validation Services for the pharmaceutical, biotechnology and medical
device industries. Our mission is to provide consulting expertise to
companies whose computerized systems must comply with published standards,
regulations, and requirements. SEC can help you identify, prioritize, and
resolve your Part 11 compliance problems with laboratory (and other)
computer systems.
SecureSynergy Pvt ltd
SecureSynergy is a global technology consulting and services company
across India, Middle East, ASEAN, ANZ & USA. Certified BS7799,
SecureSynergy specializes in design, implementation, monitoring &
managing security. SecureSynergy can be reached at securesynergy.com.
Sensors
2 Information
At "S2I", our goal is to provide customers with useful,
validated, real-time, nondestructive sensor data for critical, compliant
laboratory and manufacturing processes. Deliverables include an integrated
project proposal consisting of analytical solutions, suggested
sensor/instrument platforms, development requirements, computer
qualification/ validation, instrument qualification, CFR Part 11, and
implementation support.
Sequence, Inc.
Sequence Inc takes pride in providing validation (including 21 CFR Part
II) and regulatory consulting services to the Pharmaceutical and Biotech
industries. At Sequence Inc, our #1 objective is to deliver high-quality
validation services in a cost-effective manner. Through our knowledge,
experience, and integrity we offer a level of service that is
unsurpassed industry wide.
Seraphim Life Sciences
Consulting
Seraphim provides life sciences companies the full spectrum of GxP, Part
11, HIPPA and Product Approval compliance and consulting services,
including. Whether it's design or CSV, vendor selection, manufacturing or
clinical data systems, remediation or crisis intervention, clients can
count on Seraphim's speed, quality and professionalism. You can reach us
at 703-242-5649.
Serentec
Serentec Inc.'s strength is computer systems validation for clients in
FDA-regulated industries; its specialty - helping clients achieve/maintain
21 CFR Part 11 compliance. By planning, managing and executing remediation
projects, we don't just tell clients what's wrong - we help them get it
right. Serentec's capabilities span Automation, Information, and
Laboratory Systems.
Smith Hanley Consulting
Group
Part 11 Validation Compliance
As recognized providers of technical staffing expertise in the pharma
industry for over 20 years, Smith Hanley Consulting Group
supports Part 11 and 211 Validation requirements for 21CFR with contract
consultants including Principals, validation specialists, and tech
writers.
Expertise across cGLP, cGMP, cGCP, and IT areas in all phases of project
from risk assessment and planning, remediation, auditing, plan
development and execution, documentation.
SoftDev - Offshore Software Development Company
Full spectrum of software development services - analysis and design, development, testing and implementation. Dozens of projects in E-Management system development, CRM, ERP, E-Commerce, Security.
Software
CPR
SoftwareCPR provides consulting and training in FDA regulated software
validation and Part 11 compliance. SoftwareCPR experts can help in the
selection and validation of solutions as well as the evaluation of
regulatory risk. SoftwareCPR.com also provides a variety of Part 11 and
software validation training aides and validation and procedure examples.
Software
Quality Consulting
Software Quality Consulting provides software development, quality
assurance, and validation services to help medical device manufacturers
understand and comply with FDA regulations, including the QSR and Part 11,
as they apply to software. With over 25 years of software quality
experience, Software Quality Consulting provides tailored on-site
training, compliance audits and gap analysis, software validation testing,
software development, and software process improvement services.
Software
Testing Services
Software Testing Services, Inc. is a leading software quality assurance
consulting company focusing on the life sciences, telecommunications, and
financial services industries. Our professional services include staff
augmentation, outsourced services, and support for all aspects of software
quality assurance. We offer comprehensive Computerized System Validation
services and full support for 21 CFR Part 11. Our consultants have the
knowledge of FDA regulations and the experience in applying best practices
to help you meet your quality and compliance goals methodically and
cost-effectively.
Specdoc
Partnership
Specdoc Partnership is an independent firm specializing in Quality
Assurance, specifications and documentation. Our active involvement in
compliance with legal requirements (Pharma, health & safety) exceeds
ten years and we can offer relevant, up to date advice and guidance to
ensure that your firm is in compliance at optimum effort. Specdoc can
provide expert assistance with compliance assessments for cGxP, e-record,
e-signature, 21CFR11, and EC Directive 1999/93/EC.
SQA
Global Resources
SQA Global Resources provides project augmentation resources in the areas
of software quality assurance, testing and systems validation to business
and industry throughout the U.S. SQA engineers, testing professionals,
managers and business consultants contribute to software applications and
systems validation and performance across all business platforms and
operating systems.
Stelex
Stelex provides enterprise-wide compliance solutions to regulated industries in the Pharmaceutical, Medical Device, Diagnostic and Biotechnology sectors. The firm delivers a comprehensive suite of Validation, Technology, Regulatory and Business solutions. Additionally, Stelex offers ComplianceBuilder, the 21 CFR Part 11 Compliance Infrastructure Solution.
For over 17 years, we have built our reputation on the long-term relationships we have established with our clients and partners.
STV Consultants
STV Consultants provide consulting services to organisations lloking for
assisance with: Computer Systems Validation, 21 CFR Part 11, Auditing,
Training, Remediation, Project Management, Custom Software Development,
IQ/OQ/PQ, Validation Master Plans, SOPs, etc
Sunrise
Llabs
A world-class product design and development company specializing in
embedded systems, user-interface design, design control, validation and
other services supporting FDA regulated companies.
SVS
SVS (Validation Systems Society) can offer you the possibility to revise
your Quality Assurance Systems, SOPs and operations in order to pass the
FDA American Inspection. The success in 6 pharmaceutical industries which
have obtained the FDA approval and also the cGMP certification in European
inspections shows how helpful our collaboration can be. SVS, the largest
advisor group in Spain, has specialized professionals on specific subjects
such as FDA Inspection, who work under FDA and European guidelines for the
pharmaceutical, chemical and veterinary industry.
Synapse Partnership
Synapse’ Validation Consulting group is dedicated to providing worldwide
validation and regulatory compliance services to the international
pharmaceutical industry and its suppliers. Our experienced consultants
work in partnership with your organisation to deliver highly effective and
efficient consultancy across the entire GxP scope (GMP, GCP, GLP). This
expertise is captured in Synapse VT, a unique knowledge-based toolkit to
ensure high quality and rapid achievement of your objectives.
Synaptx
Synaptx offers companies compliance solutions to meet such regulatory
requirements on a multitude of levels. By partnering with Synaptx, small
to mid-sized businesses avoid recreating the wheel, and have the advantage
of established methods we have set in place. We provide the expertise of
an established process for assessment, documentation, implementation and
training to achieve Part 11 compliance.
Systonomy
Systonomy provides specialized training, technical, and consulting
services in Computerized Systems Validation by combining state of the art
practices from: Regulatory requirements and industry guidance such as GAMP;
Software Process Improvement and Assessment models CMM®, SPICE and others;
Six Sigma methodologies and Statistical Process; Good practices for
Electronic Records and Signatures Management including 21 CFR part 11;
Information Security Management Systems such BS7799/ISO 17999.
T
& G Solutions
T & G Solutions are a validation and compliance service company
providing integrated solutions to the highly regulated pharmaceutical
industry. In the years of our existence we have build up an expertise on
software validation. With our extensive industry knowledge, we assist our
clients in complying with all applicable industry practices (cGMP, GLP,
GCP) and EU and FDA regulations concerning e-records and e-signatures
(Annex 11 and 21 CFR part 11)
Taratec
Development
Taratec Development Corporation is a leading provider of e-technology and
specialized computer systems services and solutions to assure quality and
regulatory compliance in the highly regulated life science industry. By
pairing e-technology and regulations, Taratec has become the authority on
Web-enabling the life sciences supply chain and e-records and e-signatures
(21 CFR Part 11) solutions. Taratec is headquartered in Bridgewater, NJ
with offices in Philadelphia and Chicago.
Team
2000
Partnering many of the major UK based Pharmaceutical companies, Biotech
companies and Specialist consultancies to help them to exceed their
regulatory obligations, Team 2000 is rapidly becoming the market leader in
the recruitment of professionals in the Validation & Regulatory
Compliance market.
Tescom
Tescom, a global software quality assurance company with over 12 years of
experience in the software-testing environment is a leading consultancy in
FDA compliance and software validations. We provide a pragmatic and
cost-effective solution to your regulatory needs and involved in
determining compliance policies, validation work-plans and
implementations. Tescom operates from 3 offices in the US and 10 more
offices in Europe, Pacific Rim and Israel - optimal for global
life-sciences companies.
THINQ Compliance
THINQ Compliance combines a computer software solution (TCM) with more
than twenty years of compliance consulting services to produce durable
compliance benefits. Our principal focus is in the following vertical
industries:
-
Life Sciences: Pharmaceutical,
Medical Devices & Bio-tech, Medical Electronics
-
High Technology: Electronics,
Hybrid-environments
-
Aerospace: Aerospace Equipment,
Aerospace High-tech Manufacturing, Aerospace Electronics
Tompkins
Associates
Tompkins Associates are the Global leaders in Total Operations consulting,
information technology implementation, and material handling integration.
Our total, hands-on approach increases return on assets and improves speed
and accuracy in the pharmaceutical supply chain for greater customer
satisfaction. Tompkins provides end-to-end solutions including a thorough
understanding of 21 CFR part 11 and validation services.
TrustEra
The FDA requires electronic systems to be trustworthy. trustEra has
pioneered the comprehensive definition of digital trustworthiness and its
implications for electronic systems. trustEra provides software based on a
patent-pending architecture, for customers and partners to accelerate
compliance to 21CFR Part 11. The software takes a top-down approach,
driving management objectives to the most granular system levels and
demonstrates end-to-end electronic integrity, admissibility and
compliance.
US
Data Management
US Data Management provides validation consulting services for computer
system compliance to government and regulatory requirements. We provide
corporate risk assessments, validation strategies, vendor audits, and
software and computer systems validation for pharmaceutical, medical
device, life science and healthcare organizations.
Valicom, Inc.
Valicom, Inc. is a validation and GxP consulting firm based in Southern
California. We offer a range of validation and quality services,
specializing in computer system validation.
Valicom brings to you the combination of technical expertise, hands-on
experience, and regulatory knowledge needed to complete your validation
and FDA compliance projects.
Valicor
ValiCor Associates, Inc. is a leading full service validation firm serving
the pharmaceutical, medical device and biotechnology industries. ValiCor
has extensive experience in performing compliance audits and systems
qualifications for 21 CFR Part 11. Our staff of former FDA Inspectors and
Computer Validation Specialists has the knowledge and expertise to help
the pharmaceutical industry comply with 21 CFR Part 11.
Valid
Systems
Valid Systems provides components and solutions for
electronic record keeping in compliance with the guidelines of the
regulatory community. Using a centralized policy management interface, the
ValidRepository record keeping policies are set to 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. Based on these policy
settings you can configure your system to meet the 21CFR Part 11
requirements needed in your business.
Validation
and Regulatory Services Practice
The Validation and Regulatory Services Practice (VRSP) works as an
independent organization within FCG. This practice provides clients with
the expertise to evaluate, structure, implement, and maintain effective
quality programs that ensure compliance with applicable regulations. The
VRSP client profile spans the R&D, manufacturing, laboratory,
clinical, and regulatory domains.
Validation
Associates
Validation Associates,
Inc. provides project consulting, vendor assessments, and training
services to our clients in the pharmaceutical, biotechnology, and
medical device industries.
Validation
Technologies.
Validation Technologies Inc. (VTI) is a focused business unit providing
today's global pharmaceutical and biotech companies with regulatory
compliant automation, validation and engineering solutions. The unit
incorporates resources from Validation Technologies (VT) and the
pharmaceutical automation group of Walsh Automation (both acquired by
Invensys in August 2000), plus other appropriate Invensys resources.
Headquartered in Montreal, Quebec, Canada, Invensys Pharmaceutical
Solutions' resources are distributed throughout North America and Europe.
ValiMation
ValiMation is a Total Solutions Provider to the Life Sciences Industries.
ValiMation provides GxP Validation and Compliance, Controls Systems
Integration and IT Application Development services. Our expertise in
these core areas enables us to provide effective solutions for 21CFR Part
11 compliance.
VALOIT, Inc.
VALOIT, Inc. is a validation service provider to the pharmaceutical,
biotech, and medical device. Our experienced professionals specialize in a
wide range of validation activities - validation planning, compliance
assessments and remediation plans, protocol development, test script
writing and execution, final report documentation, SOP development,
post-validation audits, supplier audits, and validation training.
We have multiple consultants with ERP, SAP validation project experience.
VeraQual Associates
We provide IT Validation services for FDA regulated pharm, biotech,and device industries including: Part 11 Assessment/Remediation, Master Plan design, Protocol Development/Execution, Final Reports, SOPs, Employee Training, & Auditing. VQA will develop a Project Plan for master and subordinate schedules, critical path, monitoring,& resource/progress review. We can also develop processes/procedures for the software development life cycle mgt throughout the Validation program.
Verdandi AG
Verdandi AG is an independent Quality and Process Management Consultancy, providing auditing, training and consulting services in the areas GCP, GLP, GMP, ISO 9000 & business process management. We develop SOPs, provide coaching for auditors and assist in establish effective quality assurance processes. Our clients include big and small pharma, biotech, CROs as well as Academic Research Organizations. International coverage, profound expertise.
VSI
Validation, Quaility, regulatory services, to the pharmaceutical,
medical device, and ISO community.
Winmoore
Consulting
Winmoore Consulting provides consulting services in the Biotechnology,
Medical and Pharmaceutical device industries. We offer FDA consulting and
independent testing, from review of current practices to working along
side your staff. We understand the regulations and standards, the target
audiences' expectation and the challenges implementing new technologies.
Most of all we know how to test.
Wipro Technologies
Wipro is helping Life Sciences companies run their businesses more
efficiently and in regulatory compliance (including 21 CFR Part 11).
Worldwide Pharma Solutions
WWPSI is a consulting firm that provides IT & Regulatory Compliance
services to the Pharmaceutical, Biotechnology, Chemical and Medical Device
industries. We have offices in New Jersey, Miami, Tampa and Puerto Rico.
Our services include: CSV & 21 CFR Part 11 Remediation - Instrument
Qualification & Validation - Consent Decree Orientation & Remediation -
Network Configuration/Qualification - GxP Training - Multi-Lingual
Translation of SOPs, Process Validation and Remediation Please feel free
to contact us for a confidential evaluation of your company’s
requirements.
