Homework SourseDiscusses how the updated Annex 11 compares with 21 CFR Part
Discusses how the updated Annex 11 compares with 21 CFR Part 11, Provide High Level Comparison of Annex 11 and Part 11.
Solution
21 CFR Part 11 and Annex 11 share a common objective: that all computerized systems used in GxP-regulated environments need compliance for ensuring integrity of records and data. Part 11 is strictly applicable to the United States in all FDA (Food & Drug Administration) program areas and to all manufacturers outside the U.S. who wish to gain FDA market support. Annex 11, in contrast, applies to the European Union with foreign manufacturers who are seeking EU market approval.
21 CFR Part 11 Scope: Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved under any records requirements set forth in agency system. It is valid to all GxP computerized systems that are used to store and handle electronic records and signatures that are required by the predicate regulation.
EU Annex 11 Scope: Annex 11 applies to Good Manufacturing Practices (GMP) for medicinal products for human utilize, investigational medicinal products for human utilize and veterinary medicinal products and concerns those computerized systems used in the GMP environment.
It is main to reminder that the EU Annex 11 is not a legal necessity, but a principle – albeit a strongly suggested guideline. 21 CFR Part 11 is, however, a rule set by the U.S.
High Level Comparison of Annex 11 and Part 11:
Electronic records and signatures should be as hope valuable and reliable as paper records and handwritten signatures
| Annex11 | Part11 | ||
| Range | Computerized systems as part of GMP regulated actions. Application should be validated. IT communications should be qualified | Electronic records and signatures as used for all FDA regulated actions | |
| Focus | Risk- based quality management of programmed systems | Using electronic records and signatures in open and closed computer systems | |
| Objective | Using a computerized system should make sure the equal product quality and quality guarantee as manual systems with no increase on the whole risk. |
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