New PIC/S Draft Guideline on Computer Validation

The PIC/S (Pharmaceutical Inspection Cooperation Scheme) is - as successor of the PIC - an association of the inspection authorities of a number of countries (unfortunately not including the USA).

The document is based on the PIC GMP Guideline / Annex 11 and the EC GMP Guideline / Annex 11 respectively and is meant to provide the inspectors of the member countries with recommendations and background information on the inspection of computerised systems. Even though the document is primarily directed at the inspectors of the PIC/S member countries and intended to assist them in their inspections, it is also of great interest to the pharmaceutical industry. The PIC/S offers all those concerned (authorities, industry) the opportunity to hand in comments until 30 June 2002.

The document itself consists of 3 chapters - preamble / implementation of system / system operation, inspection, references. As for the state of the art, it also refers to the GAMP Guide, FDA's Part 11, ISO, IEEE and other standards.

One of the main demands of the document with regard to "critical GxP applications" is the call for user requirement specifications and a well-documented risk analysis for the various system options.

The chapter "Implementation of System", which clearly follows the well-known "Life Cycle Scheme", goes into details for the following items:

• Implementation of Computerised Systems
• The Structure and Functions of Computer Systems
• Planning and Life-cycle Management
• Information Technology Management and Administration
• User Requirement Specifications (URS)
• Functional Specifications
• 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

In the chapter "System Operation / Inspection / References" you will find the following topics:

• 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 Memoirs
• References for Relevant Standards and GMP Guides/Codes
• Suggested Further Reading
• Glossary of Terms
• Abbreviations used in the Document
• Acknowledgements
• Table of Amendments

Above all the checklists and the aide memoirs merit special attention and can certainly also be used within the companies as a helpful tool for pre-inspection preparation.

Those concerned should read the Draft attentively and seize the opportunity to submit comments, too. The final version will in the future be of assistance to inspectors during inspections of the PIC/S member countries.