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Why to comply with 21 cfr part 11 at different parts of the world other then United States of America >>>
Most countries have issues with electronic submissions and hence may follow the FDA 21 CFR part 11 as their guidelines. Moreover in interest of business continuity it is mandatory to have 21 CFR part 11 compliance to do business with US.
Benefits of this regulation :
1. The approval process may be shorter than before in long run
2. Access to documentation will be faster and more productive.
3. Archival space is reduced
4. The source documents may be recreated in an event of Disaster
5. Modern day laboratory equipments/analyzers generate electronic data in thus makes it anyway mandatory to follow the regulation
PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Section Contents
Subpart A—General Provisions
§ 11.1 Scope.
§ 11.2 Implementation.
§ 11.3 Definitions.
Subpart B—Electronic Records
§ 11.10 Controls for closed systems.
§ 11.30 Controls for open systems.
§ 11.50 Signature manifestations.
§ 11.70 Signature/record linking.
Subpart C—Electronic Signatures
§ 11.100 General requirements.
§ 11.200 Electronic signature components and controls.
§ 11.300 Controls for identification codes/passwords.
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