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Computer Integrated Part Eleven Resolution
CIPER is an Assessment Management & Decision modelling tool
for 21 CFR Part 11 compliance requirements. The objects of the assessment are
carried through a systematic process of evaluation & analysis. CIPER
provides database support and integrated accessories, such as multi-level
competency training, to ensure clear understanding of the tasks and convergence
of the requirements to meaningful results.
21 CFR Part 11 Regulation Facilitator
Integrated case studies
Final Evaluation Report
On-line technical support
21 CFR Part 11 Web-Digest
Web-based Part 11 Challenge studies & examinations
21 CFR Part 11 has been "around" for almost 5 years;
however, its impact only recently been "really felt." FDA Warning
Letters statistics provide good guidance of its significance and the urgency to
What are the benefits of CIPER?
CIPER offers critical expertise and turnkey solution to expedite
the process of assessment, risk analysis, and to understand how to fill the gap
in a cost effective manner between the existing (legacy) systems and the
Is CIPER sufficient to solve my compliance needs?
Very important characteristics of the regulation is the
development of a 21 CFR Part 11 culture in the company, which includes in
addition of compliant computer systems:
OPULUS Part Eleven Solution (OPES) is an integrated package for
the development of the 21 CFR Part 11 culture. OPES includes:
21 CFR Part 11 Basics - CACTUS Core Competency Training
21 CFR Part 11 for QA & IT - CACTUS Core Competency
Training program, and
CIPER - Computer Integrated Part Eleven Resolution.