21CFR guidelines

What is 21CFR _Part 11. How does it work?

21 CFR it is the number of rules and regulations of USA totally 1-50 rules are there

CFR Means code of federal and regulations

21 CFR Part 11, is Electronic Records; Electronic Signatures- Scope & Application (August 2003
Pharmaceutical CGMPs

USFDA intends to enforce provisions related to the following controls and requirements:
· Limiting system access to authorized individuals
· Use of operational system checks
· Use of authority checks
· Use of device checks
· Determination that persons who develop, maintain, or use electronic systems have the
education, training, and experience to perform their assigned tasks
· Establishment of and adherence to written policies that hold individuals accountable for
actions initiated under their electronic signatures
· Appropriate controls over systems documentation
· Controls for open systems corresponding to controls for closed systems bulleted above (§
· requirements related to electronic signatures (e.g., §§ 11.50, 11.70, 11.100, 11.200, and

FDA expects continued compliance with these provisions, and we will continue to enforce them.
Furthermore, persons must comply with applicable predicate rules, and records that are required
to be maintained or submitted must remain secure and reliable in accordance with the predicate Rules.
Approach to Specific Part 11 Requirements includes,

  1. Validation
  2. Audit Trail
  3. Legacy Systems
  4. Copies of Records
  5. Record Retention

Please refer and read above mentioned and related USFDA guidances to industry.

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