International Regulations and Guidance for Computer Systems and
Software and computer systems used in regulated
environments should be well controlled and validated. While there is not
much detail in regulations there are some useful guidelines available. We
find the PIC/S Guide: Good Practices for Computerized Systems in Regulated
"GxP" Environments most useful.
Annex 11 for European GMPs
This Annex describes the requirements for using computerized systems in
the GMP sector. In addition, this Annex is also applicable to the data entry
part of the GCP area as described in the EU-GCP Guideline. Requirements
include validation, personnel and system requirements such as electronic
audit trail and built-in checks of the correct entry and processing of data.
Based on Annex 11 of the EU-GMP guideline. Developed by the APV
Specialist Section Information Technology. 27 pages.
The brevity of the sections in Annex 11 leaves much room for interpretation,
creating considerable uncertainty among the manufacturers and users of
computerized systems. That is why the members of the APV Specialist Section
Information Technology have interpreted Annex 11 on the basis of previous
guidelines, publications and their own experience.
PIC/S Good Practices Guidance for Inspectors
Good Practices for Computerised Systems in Regulated "GXP" Environments
Developed by the Pharmaceutical Inspection Convention Scheme (PIC/S). The
purpose of this document is to provide recommendations and background
information concerning computerised systems that will be of assistance to
inspectors for training purposes and during the inspection of computerised
systems. The document will be of assistance to all Good Practice Inspectors
responsible for inspecting applications in the regulated pharmaceutical
sector1; hence the use of the acronym GxP in the title. It is recognised
that not all companies subjected to GLP inspections are linked to the
regulated pharmaceutical sector. However, it is considered that the guidance
contained within this PIC/S document may also be beneficial to companies
subjected to other regulatory frameworks and GLP inspection
The guidance document is intended to provide a logical explanation of the
basic requirements for the implementation, validation and operation of
With 54 pages the guidance is very detailed. Specifically useful in
preparation for inspections is a six page checklist.
Considered to be the primary GxP regulatory reference document for using
OECD Consensus Document
The Application of the Principles of GLP to Computerised Systems
(must rename the file to PDF extension after
The OECD is developing consensus documents that are aimed to reach a
common understanding of specific aspects of, for example, compliance with
GLP and explicitly for the application and interpretation of GLP principles.
Typically the documents are developed through OECD consensus workshops,
published through the OECD and implemented in OECD member countries as local
This document gives guidance on using computers in GLP regulated
PDA Technical Report
Qualification of Computerized Laboratory Data Acquisition Systems
(Hit 'publications store', search e-store for 'technical reports' and
select technical paper number 31)
Was prepared by the PhRMA CSVWG (now the PDA Computer Validation Issues
Task Group) and the PDA Computer Related Systems-Laboratory Systems Task
Group. The purpose of the Report is to provide guidance to laboratory
scientists, technicians and managers responsible for the implementation,
testing, control and usage of Laboratory Data Acquisition Systems (LDAS)
used within a GMP-, GLP- or GCP-regulated environment. TR 31 specifically
addresses computerized LDAS within a regulated environment, but is also
applicable to systems considered critical to the operation of a company,
department or function, regardless of the system's regulatory impact.
1999; 12 pp; $75 members/$270 nonmembers
GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control
Systems - GAMP 5
The guide aims to assist companies in the healthcare industries to
achieve validated and compliant automated systems. It provides guidance to
the suppliers of those automated systems on their development and
maintenance by following good practice, and assists the suppliers in
producing the necessary documentation required to support validation.
Regulatory Guide - Japan
Guidelines for Using Computers in GMP Environment
Japan GMPs have specific requirements for computers. The appointment of a
'responsible person' is just one example.
Regulatory Guide - Japan - PFSB Notification, No. 0401022
Electronic Records/Electronic Signature
Part 11 equivalent for Japan.
Computer Validation Guide for API Manufacturing
Final Draft, Version 2, December 2002