Annex 11 version 2011 of GMP Europe and the relaunch of the 21 CFR part 11 program by the FDA put computerized systems and electronic records back at the forefront of inspections. The Japanese also have a text that regulates computerized systems.
Systems using electronic records and signatures must comply with the requirements of fda 21 cfr part 11 of the FDA and the associated scope and application guide if products are sold in the USA. The 21CFRPART11 applies to any product: drug or medical devices.
If you sell your medicines in Europe, Annex 11 of the GMP applies and the PIC / S PI011-3 guide must be taken into account. But beyond the USA and Europe, many international regulatory agencies are now part of the PIC / S making PI 011-3 the international benchmark for the management of computerized and automated systems.
The Japanese authority MHHLW published in 2010 the “Guideline on Management of Computerized Systems for Marketing Authorization, other authorities do the same: China FDA GMP Annex – Computerized systems. Chinese annex relatively close to EU GMP Annex 11-Computerized systems.
GAMP 5, a guide recognized by industry and regulatory bodies, is not left out since it incorporates all the requirements of the PIC / S. The international consensus is therefore on the move.
Goals
Master the challenges of 21 CFR part 11, its field of application and its requirements, in particular the current expectations of authorities in terms of data integrity.
Master the requirements of Annex 11 of GMP Europe.
Distinguish the latest developments in European, American and international requirements, in particular the requirements of the principles of Data Integrity.
Evaluate the compliance of existing systems.
Be able to specify and assess compliance with 21 CFR part 11 and annex 11 of a system.
Master the recommendations of PIC / S PI011-3 and its international influence.
Program
1. Issue and field of application
Objectives of the module : to know the objectives and the field of application of 21 CFR part 11 and of appendix 11.
Overview of the major texts on electronic signatures.
Definition of a recording and an electronic signature.
The objectives of 21 CFR part 11.
The objectives of annex 11 of GMP Europe.
The objectives of PI011-3 of the PIC / S.
The objectives of the PFSB / CND notification No.1021-11, 2010.
Management of SI / SA of MHLW Japan.
Systems subject to electronic records and signatures requirements Identify electronic records.
To what extent can / should electronic signatures be implemented?
Game
2. 21 CFR part 11 – Requirements on electronic records
Objectives of the module : know the requirements of 21 CFR part 11 regarding electronic records, have an up-to-date reading of the text integrating the principles of Data Integrity.
Distinction between an “open system” and a “closed system”.
21 CFR part 11 requirements for Electronic Records.
What has the “Scope and Application” guide changed?
3. 21 CFR part 11 – Requirements on electronic signatures
Objectives of the module : To know the requirements of 21 CFR part 11 concerning electronic signatures.
Panorama of signatures and their characteristics: handwritten signatures, identifiers, passwords, biometrics.
Requirements of 21 CFR part 11 depending on the types of signatures used.
The declaration to the FDA.
Game
4. Position of the FDA
Objectives of the module : to know the current position of the FDA on 21 CFR part 11.
The attitude of the FDA towards existing systems (“Legacy systems”).
Review of the most common Warning Letters published on the topics of 21 CFR part 11. Reflection on hybrid systems.
The need for the compliance plan.
The latest developments in the interpretation of the text. The FDA white paper of July 2010.
5. GMP Europe Annex 11 – Requirements on computerized and automated systems
Objectives of the module : to know the requirements of appendix 11 version 2011 concerning computerized and automated systems.
Know the differences between 21 CFR part 11 and appendix 11.
Set
Requirements of appendix 11 concerning electronic records: control of modifications, access management, audit trail…
Requirements of appendix 11 concerning computerized and automated systems: validation , system documentation, control of modifications …
6. Differences between GMP Europe Annex 11 and FDA 21 CFR part 11
Objectives of the module : know the differences between 21 CFR part 11 and annex 11.
Game
The differences between 21 CFR Part 11 and Annex 11.
The notion of analysis of risks.
7. PIC / S PI011-3 – Recommendations on computerized and automated systems
Objectives of the module : to know the content of PI 011-3 and the expectations of PIC / S inspectors on the management of computerized and automated systems.
Recommendations of the PIC / S PI011-3 guide.
The implications of PIC / S PI011-3.
8. Guideline on Management of Computerized Systems for Marketing Authorization. (PFSB / CND notification
No. 1021-11, 2010). IS / SA management of MHLW Japan
Objective of the module : Know the content of the Japanese text and MHLW’s expectations on IS / SA management.