Annex 11: Computerised Systems Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive

Supplementary guidelines to the EC-GMP Guide with specific requirements for computerized systems.

2023年7月13日 · EU Annex 11 outlines requirements for using computerized systems in the Life Science industries operating within the European Union. It is a guidance document for interpreting the principles of good manufacturing practice (GMP) for medicinal products.

2023年7月19日 · EU Annex 11 addresses computerized systems used in GMP-regulated activities, providing appropriate implementation and management guidelines. While 21 CFR Part 11 specifically targets electronic records and signatures, EU Annex 11 takes a broader approach by encompassing the whole computerized system. Regulatory Authority

2023年3月20日 · Annex 11 is the European equivalent of the FDA’s 21 CFR Part 11. Part 11 includes electronic records and electronic signatures for FDA-regulated activities. Annex 11 covers computerized systems for GMP-regulated activities.

2024年7月29日 · Annex 11 consists of four sections: The first section provides general guidance on topics such as risk management, personnel, suppliers, and service providers. The second section provides guidelines for the project phase and …

2021年12月8日 · Annex 11 is ‘how to’ in tone while Part 11 is ‘thou shalt.’” The EU published Annex 11 in 1992 as one of several guidance documents that supplements the 27-member states’ GMP rules. It applies to all human and veterinary products made or sold in the EU.

2024年3月15日 · Specifically, 21 CFR Part 11 governs electronic records and signatures in the FDA-regulated landscape and is more specific, while EU GMP Annex 11 guides computerized systems in the EU's GMP-regulated activities focusing on general guidance, effective implementation, and validation.

2022年11月30日 · The current EU GMP Annex 11 "Computerised Systems" was published in 2011. Due to new technological and regulatory developments, a forthcoming revision of Annex 11 has been discussed for some time. On 16 November 2022, the EMA published a concept paper for public comment.

Annex 11 is a regulatory requirement for organizations that manage and store data using electronic systems. It lays out the principles and guidelines that organizations must adhere to in order to ensure the dependability, security, and integrity of electronic records and signatures.