New PIC/S Guidance on Computer Validation

GMP News No. 353

GMP News
13 October 2003

New PIC/S Guidance on Computer Validation

On 1 September 2003, the PIC/S document "PIC/S Guidance – Good Practices for computerised systems in regulated 'GxP' environments" ( came into force.

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.

Part One – Preamble

  • Purpose
  • Scope
  • Introduction
  • Part Two – Implementation of System (draft titles in italics)

  • Implementation of computerised Systems
  • The structure and functions of the computer system(s)
  • Planning and life-cycle management
  • Management and responsibilities (Information Technology Management and Administration)
  • User Requirement Specifications (URS)
  • Functional Specifications
  • Suppliers, software developers and quality management (Software and Hardware Selection)
  • Important QMS and software standards attributes
  • Testing
  • Validation strategies and priorities
  • GAMP validation approach based on different categories of software products
  • Retrospective validation
  • Part Three – System Operation / Inspections / References

  • Change Management
  • Change control and error report systems
  • System security, including back-up
  • Data changes – audit trail / critical data entry
  • Electronic records and electronic signatures
  • Personnel
  • Inspection considerations
  • Checklists and aide memoires
  • References for relevant standards and GMP guides/codes
  • Suggested further reading
  • Glossary of terms
  • 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.

    Here some of the changes compared with the draft document:

    2.3. Reference to GDP (Good Distribution Practice)
    4.6. The validation documentation must cover all steps of the life cycle. The user has to be able to explain the documentation.
    9.4. User requirements must be the basis for risk analysis.
    14.3. Mention of a new document of the GAMP Forum Special Interest Group (SIG) "Functional Risk Assessment." In this document, special emphasis is placed on risk analysis.
    15. The GAMP 4 software categories are taken over.
    16. Retrospective validation: no alternative any more for new systems. As for old systems, reference is made to an expected GAMP Guidance "Legacy Systems." A system description, a test against the specifications, and a risk analysis are required.
    21. There have been many changes in the field of "Electronic Records/ Electronic Signatures;" probably this was partly in view of the FDA's changes in the 21 CFR Part 11 environment.
    Furthermore, this document includes comprehensive check lists and aide memoires, which can certainly be very useful for every company in the preparation for an inspection.

    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:

    Dr Andreas Mangel

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