New PIC/S Guidance on Computer Validation

GMP News No. 353

GMP News
13 October 2003

NewPIC/S Guidance on Computer Validation

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

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

The document is primarily directed at the inspectors of the PIC/S membercountries, to whom it is meant to provide guidance on how to conductinspections of "computerised systems." It could thus be comparedwith FDA's "Guides for Inspection," which supply the inspectorswith interpretations of the regulations concerning specific fields orquestions. Although these documents have, of course, been written mainly for theinspectors, these interpretation aids are also very important for thepharmaceutical industry.

In January 2002, PIC/S published a draft document for commenting by theinvolved parties. These comments have been taken into consideration in thefinal 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 Managementand Administration)
  • User Requirement Specifications (URS)
  • Functional Specifications
  • Suppliers, software developers and quality management (Software andHardware Selection)
  • Important QMS and software standards attributes
  • Testing
  • Validation strategies and priorities
  • GAMP validation approach based on different categories of softwareproducts
  • 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 towardsthe requirements of GAMP 4 (there have been controversial discussions onthis - nonetheless positive - approach) and that many of the changes incomparison to the draft are due to the implementation of GAMP 4requirements.

Here some of the changes compared with the draft document:

2.3.Reference to GDP (Good DistributionPractice)
4.6.The validation documentation must cover allsteps of the life cycle. The user has to be able to explain thedocumentation.
9.4.User requirements must be the basis for riskanalysis.
14.3.Mention of a new document of the GAMP ForumSpecial Interest Group (SIG) "Functional Risk Assessment." In thisdocument, special emphasis is placed on risk analysis.
15.The GAMP 4 software categories are taken over.
16.Retrospective validation: no alternative anymore for new systems. As for old systems, reference is made to an expectedGAMP Guidance "Legacy Systems." A system description, a testagainst the specifications, and a risk analysis are required.
21.There have been many changes in the field of"Electronic Records/ Electronic Signatures;" probably this waspartly in view of the FDA's changes in the 21 CFR Part 11 environment.
Furthermore, this document includescomprehensive check lists and aide memoires, which can certainly be veryuseful for every company in the preparation for an inspection.

Generally,one can say that this PIC/S document defines the state of affairs in thefield of computer validation from the viewpoint of the supervisoryauthorities. Both the current developments concerning the industrialassociations (GAMP 4 and BestPractice Guides) and the developments within the US-American supervisoryauthority FDA are taken into consideration.

Dr Andreas Mangel


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