Audit Trail Specification & Audit Trail Review

In 2016 a lot of questions were asked about the good old Audit Trail and about the new topic of the so called “Audit Trail Review”. CCS has published a concept paper for an Audit Trail Specification and some considerations for the Audit Trail Review approach.

  • What is an Audit Trail – in the GMP context of the PQS?
  • What is the difference of a log and a GMP Data Audit Trail?
  • What is an Audit Trail Review good for? How often? Why?
  • What should be reviewed – function or data? What are the results – knowledge management?
  • Detection of data manipulation? Data Audit Trail or Activity Trail required?
  • Which data should be audit trailed and which one should be reviewed?
  • What are CPPs, CQAs, system parameters and/or master data / meta data?
  • How should a specification look like for a real GMP Data Audit Trail?
  • Why is the reason for change so important for a real GMP Data Audit Trail?
  • User roles and concept: Different types for the role Administrator?
  • GMP documentation with instructions and records vs. electronic data?
  • What is GMP critical data and knowledge management – on product and process level?
  • Which roles should be audit trailed and when and if so, how?
  • Is the Audit Trail Review executed manually or automatically?

You may find some answers or at least ideas for that in the free download provided by CCS below:

Download (revision 1): CCS_ Audit Trail Specification and Review_ 2017_rev1

Find more free Downloads at our: Download Page

Link – New Article: Who will review the Audit Trail Review?

Contact us for more information:

Aide Mémoire 07121202 der ZLG (Annex 11): Überwachung computergestützter Systeme

Die ZLG hat nun das angekündigte Aide Memoire bzgl. EU GMP Leitfaden – Anhang 11 veröffentlicht.

The German ZLG has published the Inspection Aide Memoire based on EU GMP Annex 11. The current version is available in German language only.


Download AIDE MEMOIRE – Annex 11 (German): ZLG_AM_QS_07121202

Basis: EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines

UPDATE: Please find here the English translation of the Aide Memoire.


NEW ANNEX 11 – Computerised Systems – revision January 2011 – CCS solution package

EMA published today the new GMP Annex 11 – Computerised Systems – revision January 2011 – download your copy here: PDF 

The deadline for coming into operation of the new Annex 11 is 30th June 2011. 

  • Find here also the new EudraLex Chapter 4 – Documentation: PDF
  • Report “New Annex 11” in German from the GMP Verlag:  Info

Basic Principle of the new Annex 11 (Ref.: annex11_01-2011_en):

 This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.

The application should be validated; IT infrastructure should be qualified. 

Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process  control or quality assurance. There should be no increase in the overall risk of the process.

Contact now CCS for the new Annex 11 implementation package for efficient and compliant integration: