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International Regulations and Guidance for Computer Systems and Electronic Records

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

Computerized Systems

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.


APV Guideline

Computerized Systems

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 computerised systems.
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 computer computers.


OECD Consensus Document

The Application of the Principles of GLP to Computerised Systems

(must rename the file to PDF extension after download!!!)

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 regulations.

This document gives guidance on using computers in GLP regulated environments


PDA Technical Report

Validation and 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 Guide

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