JSM Activity #2002-16C

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Activity ID:  2002-16C
Title
A Journey into Regulatory Compliance: An Introduction to 21 CFR Part II
Date / Time / Room Sponsor Type
08/12/2002
8:00 AM - 12:00 PM
Room: H-Lincoln Suite 		ASA Other
Organizer: n/a
Chair: n/a
CE Presenter - Westinghouse
- Cleveland Clinic Foundation
Description

Clinical research encompasses a vast arena that may include pharmaceutical companies, medical device companies, academic research institutions and clinical care institutions. Consequently, implementing processes for 21 CFR Part 11 compliance at a clinical research institution with multiple governing regulatory bodies requires strategy and careful planning. Validation of computer systems, as the collection of processes to ensure that the computer performs the intended functions, is widely utilized in safety industries. FDA regulation for electronic records and electronic signatures, 21 CFR Part 11, and the proposed HIPAA regulation, 45 CFR Part 142, brings this concept to broad areas of the health care industry. Validation of computer systems now includes validating the system to ensure regulatory requirements are achieved. Combining the techniques of structured analysis and risk control within the validation process can establish a harmonized validation demonstrating compliance of all computer system requirements. The computer system validation principles presented are applicable to validating other regulated processes in pharmaceutical, biotechnology, and medical device industries.
JSM 2002

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Revised March 2002