EU GMP Annex 11 Updates
New EU GMP Annex 11 on Computerized Systems Released
On Jan 3, 2011, EU has released a new final version of
Annex 11. Together with the updated EU GMP Chapter 4 on
documentation it is the EU equivalent to FDA's Part 11.
Pharmaceutical industry marketing products to Europe must comply
with the annex by July 1, 2011.
Compared to the older version it has more detailed and some very
specific requirements, for example computer system printouts of
critical records should indicate if any of the data has been changed
since the original entry. It addresses the regulatory needs of
modern IT equipment and when implemented right, also has business
benefits through reduced failure rates. The document is a good
framework for validation and using computer systems and handling
electronic records in different regulated environments. On the other
hand it leaves a lot of room for interpretation that raises lots of
questions. Attend the new Labcompliance
audio seminar to learn everything about the new Annex 11 and
receive 10+ best practice for easy implementation.
Comparison of Annex 11 with other official Documents
Orlando Lopez has published a document that relates Annex 11 requirements
to other official regulations and guidance documents. It is organized in
table format. In the first of six columns it lists the contents of Annex 11
together with the paragraph numbers. Columns two to five list the related
section numbers of
- Annex 11 Version 1993,
- US FDA 21 CFR Part 211,
- US FDA Part 820 and
- US FDA 21 CFR Part 11
respectively. Column six lists related section numbers of other official
documents, for example
- EU Directions 2003/94/EC
- Eudralex Volume 4, Good Manufacturing Practices, Documentation
- PIC/S PI 011-3
- ICH Q7
- US FDA CPG 7348.810
- ICH Q9
- US FDA 21 CFR Parts 58, 110, 312, 425. 606, 812,
- NIST Risk Management Guide for Information Technology Systems
- US FDA Part 11 Guide: Electronic Records, Electronic Signatures:
Scope and Applications
- US FDA Guide: General Principles of Software Validation
- US FDA CPG 130.400
- APV Guideline: "Computerised Systems" based on Annex 11 (Version
- ICH GCP
- EU Directive 1999/93/EC
- DOD 5015.2-STD.
- GAMP/ISPE, Risk Assessment for Use of Automated Systems
To download the document,
EMA Answers Questions Related to the New EU Annex 11
Since the release of the new Version of the EU GMP Annex 11 there are
many questions related to implementing Annex 11. EMA has included 10
frequently asked questions and answers on its "Q&A: Good Manufacturing
website. Some of the questions are generic, for example, about
revalidation of computer systems and validation of spreadsheets. Others are
specific to Annex 11, for example related to the implementation of
requirement that print-outs should indicated any changes to data since the
- Appropriate controls for electronic documents such as templates
should be implemented. Are there any specific requirements for templates
- Which type of accuracy checks (Annex 11 p 6) are expected for use
of spreadsheets? (H+V February 2011)
- Are there any specific considerations for the validation of
spreadsheets? (H+V February 2011)
- Which measures are required to ensure data security of databases?
(H+V February 2011)
- At which phases of the system lifecycle risk management is
- Are user requirements needed as part of the retrospective validation
of legacy systems?
- When do I have to revalidate computerised systems?
- What are the requirements for storage time of electronic data and
- Which are the relevant validation efforts for small devices?
- What alternative controls are accepted in case a system is not
capable to generate printouts indicating if any of the data has been
changed since the original entry?
Even though the Q&As have been published by a European Agency many of the
questions also came up at our Part 11 related seminars and workshops, so in
general the answers are also applicable for FDA regulated industries.
Labcompliance Audio Seminars for Annex 11 Topics
EU agencies expect Annex 11 to be implemented by July 31, 2011.
Labcompliance offers help for understanding the principles and requirements
but also for implementing different sup paragraphs through a variety of
audio seminars. The seminars include life or recorded presentations and 10+
best practice documents for easy implementation. The documents include
master plans, SOPs, checklists and examples. The table below lists the
seminars along with the Anex 11 chapters.
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