21 CFR Part 11: Where are we now?
by Cimquest Inc.
The Food and Drug Administration's 21 CFR Part 11 regulation enables use of technology for record-keeping activities while ensuring the reliability, authenticity, integrity and usability of electronic records. In 2003, the FDA issued a single Guidance for Industry for Part 11. This white paper from Cimquest Inc. discusses two major changes brought about by the issuance: the narrower interpretation of 21 CFR Part 11, and that enforcement discretion is exercised with regard to requirements for validation, audit trails, record retention and record copying, and in the application of all Part 11 provisions to legacy systems.
| Published: | 2003 |
| Format: | |
| Length: | 8 pages |
| Type: | White paper |
| Language: | English |
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