CIPER
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.

Key Features

• Web-Integrated-Wizard

• SQL database

• 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 comply.

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 compliance requirements.

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:

• competency training,

• appropriate Standard Operating Procedures, and

• compliant attitudes.

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 program,

• 21 CFR Part 11 for QA & IT - CACTUS Core Competency Training program, and

• CIPER - Computer Integrated Part Eleven Resolution.