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GENERAL
CimQuest has extensive experience helping our
clients to understand and comply with FDA's
Electronic Records & Electronic Signatures
regulation, 21 CFR Part 11.
In 1998 CimQuest developed a Part 11 Assessment
Worksheet and Flowchart tool for our internal use.
Since then, we have licensed this tool to several of
our clients to assist them in developing their own
Part 11 programs.
Our consultants have applied their expertise in
Computerized Systems and knowledge of FDA
expectations an over three hundred projects since
this regulation was enacted in 1997. We have
executed dozens of 21 CFR Part 11 specific projects,
ranging in scope from Audits, Training, Assessments,
Remediation Project Planning & Management, to
validation of new installations and applications.
INDUSTRY ACTIVITIES
CimQuest's expertise is widely recognized in the
pharmaceutical, medical device and biotechnology
sectors of the Life Sciences industry. CimQuest is
actively involved in many Part 11 related activities
through our affiliation with several industry
organizations such as PDA, ISPE, GAMP, IVT, and
others. CimQuest advises and contributes regularly
on Part 11 compliance through participation in
comminees, task groups, conferences, presentations
and published papers.
PUBLISHED PAPERS
- Pharmaceotical Manufacturing and Packing
(European Publication) Sept. 1999:Electronic
Records; Electronic Signalure; Final Rule, 21 CFR
Part 11 - An Oven/iew & Guidance
- IVT Journal af GXP Compliance, April 2003,
I/Volume 7, Number 3 Designing and /mplementing an
Electronic Batch Record System, An Overview of
Compliance /Issues
 Part
11 White Papers
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