On 14 January 2002, PIC/S published the draft document "PIC/S Guidance – Good Practices for Computerised Systems in Regulated 'GxP'
Environments."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.
