Electronic Records and Computerized Systems Management, there is a consensus!

Systems manipulating or using electronic records and electronic signatures must be compliant to 21 CFR Part 11 regarding predefined requirements and this from the design phase or in a retrospective manner by taking into account FDA position changes since the publication of this text in 1997. However, 21 CFR Part 11 is not the only text existing and there is GMP Annex 11 at the European level and PIC/S PI011-3 document to take also into account. On the other hand, all this is in the process of changing and it is important to try to figure out what will be the future in this area to avoid designing systems that could not be compliant before they are in use. The new GMP Annex 11, which is in a review phase and the new 21 CFR Part 11 should be available in 2010. What will they change? PIC/S is not any more only European but FDA and others regulatory Agencies participate to the Guidance writing and it has become the reference for the recent new GAMP 5 version; We are then going more and more towards a true consensus!

 Understand 21 CFR part 11 stakes, its scope, application and requirements.

 Understand European GMP Annex 11 requirements.

 Know the last evolutions of European and American requirements.

 Know how evaluate existing systems compliance.

 Know how to plan and implement the remediation approach. Be capable to specify and evaluate 21 CFR part 11 compliance when buying a new system.


 Know in which way regulations linked to electronic records have evolved and will continue to evolve with ISO 17799 (Data Safety Management) and PI011-3 (Good Practices for Computerised Systems in Regulated “GXP” Environments) taken into account.

1. Stakes and Scope
Overview of main texts on electronic records and signatures. Definitions: Electronic Record, Electronic Signature. FDA objectives that are behind 21 CFR part 11. European GMP Annex 11 objectives. PIC/S PI011-3 objectives Determine among your own systems which ones are subject to electronic records and electronic signatures requirements. Identify electronic records. In which extent electronic signatures can / must be implemented?

2. 21 CFR part 11 – Electronic record requirements
Closed System versus Open System, what are the differences? Organizational, legal and technical consequences of the differences. 21 CFR part 11 requirements regarding electronic records: validation, system documentation, change management, access right management, audit trail, …. What is the impact of the guide « Scope and Application »? Risk analysis concept is integrated everywhere!

3. 21 CFR part 11 – Electronic signature requirements
Overview of signatures and of their characteristics: Handwritten signatures, identification codes in combination with passwords, biometrics, devices…. 21 CFR part 11 requirements according to the type of signature used: signature manifestations, signature/record linking, passwords, certification to send to FDA…

4. European GMP Annex 11 - Electronic record requirements
Annex 11 requirements regarding electronic records: validation, system documentation, change management, access right management, audit trail… Know the differences between 21 CFR Part 11 and GMP Annex 11.

5. PIC/S PI011-1 - Electronic record recomm-endations
PIC/S PI011-3 guidance recommendations regarding electronic records and computerized systems. Know the implications of PIC/S PI011-3.

6. FDA Position
The debate launched by the industry. FDA position regarding “Legacy systems”. Review of 483’s and Warning Letters published on the 21 CFR part 11 themes since 1997. Discussion on hybrid systems. Necessity to have a remediation plan. Last evolutions in 21 CFR part 11 interpretation.

7. Remediation approach
Put in place a project structure for ERES compliance.Create a questionnaire. System Inventory and compliance level verification.Immediate actions to implement when a system is not compliant and risks exist. Implement procedures. Implementation cost and timelines.

8. URS and New System Validation
Definition (in the URS) and evaluation (in the context of a request for quotation) of compliance requirements regarding electronic records and electronic signatures. Adaptation of the communication according to the maturity level. The main technological pitfalls (safety, audit trail, time-stamp, archiving...). Validation principles for systems subject to ERES requirements.

9. Future Evolutions
What will be the next 21 CFR part 11? GMP Annex 11 is in review process, but will it be an evolution or a revolution? Will PI011-3 from PIC/S become worldwide reference?

PRACTICAL CASE STUDY
Several practical case studies are proposed all along the training session.
A Multiple Choices Questionnaire is proposed at the end of the training session in order to evaluate the acquired knowledge.