The role of PIC/S is not clear to everybody. As the successor of PIC, PIC/S (Pharmaceutical Inspection Cooperation Scheme) is an association of inspectorates mostly - but not exclusively - from European countries (meanwhile also the US-American FDA has expressed its interest in a co-operation).

The document is primarily directed at the inspectors of the PIC/S member countries, to whom it is meant to provide guidance on how to conduct inspections of "computerised systems." It could thus be compared with FDA's "Guides for Inspection," which supply the inspectors with interpretations of the regulations concerning specific fields or questions. Although these documents have, of course, been written mainly for the inspectors, these interpretation aids are also very important for the pharmaceutical industry.

In January 2002, PIC/S published a draft document for commenting by the involved parties. These comments have been taken into consideration in the final version. 

Just as the draft, the final version comprises 3 chapters: Preamble, Implementation of System, System Operation / Inspections / References. The subtopics, too, have more or less remained the same.

2. Purpose
3. Scope
4. Introduction

Part Two – Implementation of System (draft titles in italics)

5. Implementation of computerised Systems
6. The structure and functions of the computer system(s)
7. Planning and life-cycle management
8. Management and responsibilities (Information Technology Management and Administration)
9. User Requirement Specifications (URS)
10. Functional Specifications
11. Suppliers, software developers and quality management (Software and Hardware Selection)
12. Important QMS and software standards attributes
13. Testing
14. Validation strategies and priorities
15. GAMP validation approach based on different categories of software products
16. Retrospective validation

17. Change Management
18. Change control and error report systems
19. System security, including back-up
20. Data changes – audit trail / critical data entry
21. Electronic records and electronic signatures
22. Personnel
23. Inspection considerations
24. Checklists and aide memoires
25. References for relevant standards and GMP guides/codes
26. Suggested further reading
27. Glossary of terms
28. Abbreviations used in the document

On the whole one can see that the document is strongly orientated towards the requirements of GAMP 4 (there have been controversial discussions on this - nonetheless positive - approach) and that many of the changes in comparison to the draft are due to the implementation of GAMP 4 requirements.

Generally, one can say that this PIC/S document defines the state of affairs in the field of computer validation from the viewpoint of the supervisory authorities. Both the current developments concerning the industrial associations (GAMP 4 and Best Practice Guides) and the developments within the US-American supervisory authority FDA are taken into consideration.

Especially on this topic, we recommend you the following events:

• User Requirement Specifications in Computer Validation,
  26 November 2003, Hamburg, Germany
• Risk Assessment and Change Control in Computer Validation,
  27-28 November 2003, Hamburg, Germany