CimQuests QA organization also provides compliance
auditing services to clients who are seeking an
assessment of internal and vendor regulatory
compliance integrity. CimQuest certified audit
personnel review SOPs, software development
procedures and the documented evidence of
utilization to assess the level of compliance.
Although audits normally focus on systems
validation, documentation practices in general are
evaluated relevant to the particular governing
regulations. The audit process is consistent with
the recent PDA Software Supplier Auditing and
Qualification Committee recommendations (reference
PDA Technical Report 32). The audits review
documentation and focus on:
Accuracy/Reliability
State of Control
Clarity/Comprehensiveness
Completeness/Appropriateness
An audit team will be established with
representatives from both the client and CimQuest.
The following tasks are typically accomplished
during an initial overview:
Review corporate guidelines and policies
Review validation plans
Interview individuals responsible for systems
operation
Define the system capabilities
Identify any related operations
Define interfaces with networks or other systems
Each system will be evaluated for compliance to the
governing regulations. The following categories are
typically reviewed:
System Documentation
User Documentation
Validation Documentation
Historical/Operational Data
The following are examples of audits performed by
the CimQuest auditors:
Beckman
Finn-Aqua
Fisons
HP LabSys
LabWare
Landis & Gyr
Agilent PE/Nelson
Waters
PeopleSoft
QUMAS Documentum
PPD Development
FileNet
Zymark
Learn how Cimquest's Q-Factors™
can help you create the necessary building blocks
to attain Hi-Q operational excellence.
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The
Global Compliance Alliance™ is a leading compliance
solution provider across America, Asia, and Europe.
Providing highly qualified Consultants through out the
world, the GCA gives you
the benefits of a global partner capable of dealing with
world wide multi-site projects.
Click
here to learn more about the Global
Compliance Alliance™.
Part
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