What is EU GMP Annex 11?

EU GMP Annex 11 is a guideline within the European Union's Good Manufacturing Practice (GMP) regulations that specifically addresses computerised systems used in pharmaceutical manufacturing. It outlines requirements for the validation, security, and control of these systems to ensure data integrity, reliability, and compliance with GMP principles. It covers aspects such as audit trails, electronic signatures, data backup and recovery, and periodic evaluation to maintain the validated state of the system.

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What other technologies are related to EU GMP Annex 11?

EU GMP Annex 11 Complementary Technologies

GAMP 5

GAMP 5 provides guidance on the validation of computerized systems, which is a key aspect of complying with EU GMP Annex 11. It complements Annex 11 by providing a structured approach to ensuring system quality and compliance.

21 CFR Part 11

21 CFR Part 11 is the FDA's regulation on electronic records and electronic signatures. While it is a US regulation, its principles are similar to those in EU GMP Annex 11. Therefore, knowledge of 21 CFR Part 11 is very complementary to understanding Annex 11 requirements, although not directly applicable in the EU.

Number of organizations that mention technology

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Which job functions commonly mention EU GMP Annex 11?

Test Engineer

12 Test Engineer jobs mention EU GMP Annex 11

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Automation Engineer

3 Automation Engineer jobs mention EU GMP Annex 11

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Compliance

6 Compliance jobs mention EU GMP Annex 11

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Consultant

10 Consultant jobs mention EU GMP Annex 11

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Quality Assurance

12 Quality Assurance jobs mention EU GMP Annex 11

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**EU GMP Annex 11**