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Keeping A Finger on the Pulse
of Regulatory Compliance
CimQuest, leaders in systems regulatory
compliance, invests time and effort of their senior
level staff to actively support industry recognized
professional affiliations, such as the PDA, ISPE and
ASQ. CimQuest "Keeps their Finger on the Pulse of
Regulatory Compliance - working alongside leading
Pharmaceutical Professionals and the FDA, providing
recommendations and guidance to important industry
topics such as 21 CFR Part 11.
CimQuest invested 2 1/2 man-years in supporting
PDA's Part 11 Task Group and co-authored the "Part 1
- Good Electronics Records Management" document. In
addition to the Part 11 task group, CimQuest
invested over five man-years of their senior level
staff in supporting PDA's Supplier Auditing Task
Group and co-authored PDA's Technical Report No. 32
- "Auditing of Suppliers Providing Computer Products
and Services for Regulated Pharmaceutical
Operations." In both task groups, PDA invited
CimOuest to participate in these important industry
topics - one of few consulting companies invited.
CimQuest is also an active member of the PDA's
Industry Advisory Board (IAB) for the process of
Auditing Suppliers providing computer products and
services for Regulated Pharmaceutical Operations.
 
Over the years, CimQuest has invested many man-years
in supporting the International Society of
Pharmaceutical Engineers (ISPE) as an active Member
of the Computer Validation Committee and Member of
the GAMP Americas forum. CimQuest actively
participates in presenting at ISPE sponsored
conferences and events.
CimQuest actively participates in the American
Society for Quality (ASQ). Many of CimQuest's Senior
Level staff has completed Auditor and Software
Quality Engineering certification courses provided
by ASQ. CimQuest is dedicated to providing the
latest and best educational training to their staff.
Throughout this marketing
material, professional affiliations are mentioned by
name. In most if not all, cases, the companiesŐ
names and/or logos are trademarks. It is not our
intention to claim these names or trademarks as our
own. |
Part
11 White Paper
