Expert Advice

Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars




All seminars come with 10+ best practice documents, such as SOPs, checklists, master plans


Electronic Records


Periodic Review and Evaluation of Computer Systems

With strategies and tools for FDA and EU compliance

July 28, 2011


Understanding and Implementing the New Final EU Annex 11

Learn about specific requirements and get tools for implementation



Understanding and Preparing for FDA's New Part 11 Inspection Program

With 10+ Best Practice Guides for Easy Implementation



Learning from Recent Warning Letters and 483's Related to Computer Validation and Part 11

With Case Studies to Avoid and Respond to 483's and Warning Letters



Electronic Raw Data in Regulated Environments

Definition, generation and archiving for FDA Part 11, HIPAA and SOX compliance



FDA's 21 CFR Part 11

Introduction and Strategies and Tools for Implementation



Cost Effective Electronic Data Archiving for FDA Compliance

Understanding and Implementing the New GAMP Guide



Electronic Audit Trails for FDA Compliance
Requirements - Design - Implementation - Validation - Documentation



FDA Compliant Electronic Records Management



Using the SAFE Standard for Digital Signatures

For legally enforceable IP Protection, Electronic Transactions and FDA Submissions



Auditing Computer Systems for Part 11 and Annex 11 Compliance

Prepare your organization for upcoming FDA and EU inspection



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 1993)
  • EU Directive 1999/93/EC
  • DOD 5015.2-STD.
  • GAMP/ISPE, Risk Assessment for Use of Automated Systems

To download the document, click here.

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 Practice (GMP)"  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 original entry.

  1. Appropriate controls for electronic documents such as templates should be implemented. Are there any specific requirements for templates of spreadsheets?
  2.  Which type of accuracy checks (Annex 11 p 6) are expected for use of spreadsheets? (H+V February 2011)
  3.  Are there any specific considerations for the validation of spreadsheets? (H+V February 2011)
  4. Which measures are required to ensure data security of databases? (H+V February 2011)
  5. At which phases of the system lifecycle risk management is recommended?
  6. Are user requirements needed as part of the retrospective validation of legacy systems?
  7. When do I have to revalidate computerised systems?
  8. What are the requirements for storage time of electronic data and documents?
  9.  Which are the relevant validation efforts for small devices?
  10.  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.

Annex 11 Section
Labcompliance Audio
Seminar Number & Title
All Annex 11
Understanding and Implementing the New Final EU Annex 11 (261)
Overview of history, principles and requirements of Annex 11. ,
1 Risk Management Developing a Risk Management Master Plan (266)
2 Personnel Effective GxP Training Practices (148)
3 Suppliers and Service Providers Assessment of Software and Computer System Suppliers (122)

Auditing Computer Systems for Part 11 and Annex 11 Compliance (264)
Validation and Use of Excel® Spreadsheets in Regulated Environments (265)

Computer System Validation: Step-by-Step (232)
Risk Based Validation of Software and Computer Systems (220)

Master Planning for Software and Computer Validation (212)

Requirement Management for Equipment and Computer Systems (213)

Validation of Existing/Legacy Computer Systems (207)
Data: security,integrity
Electronic Raw Data in Regulated Environments (246)
Accuracy checks
Electronic Raw Data in Regulated Environments (246)
Data storage
Cost Effective Electronic Data Archiving for FDA Compliance (184)
Electronic Raw Data in Regulated Environments (246)
Audi trails
Electronic Audit Trails for FDA Compliance (182)
10 Change and configuration management Configuration Management and Change Control of Computer Systems (164)
Periodic evaluation
Periodic Review and Evaluation of Computer Systems (271)
Preventing and Handling Security Incidents (157)
Incident Management
Contingency and Disaster Recovery Planning for Computer Systems (197)
Electronic Signatures
Batch release
Qualified person
The Qualified Person in the Pharmaceutical Industry (241)
16 Business Continuity Contingency and Disaster Recovery Planning for Computer Systems (197)
Cost Effective Electronic Data Archiving for FDA Compliance (184)

Retirement of Computer Systems (170)

E-mail this page