Direct Links to important GMP Computer Validation Guidelines

FDA Guidance for Industry: Computerized Systems used in clinical trials-Draft

This FDA guideline for computer systems is strictly speaking only intended for clinical trials, but it also contains many relevant topics for GMP.


FDA Guide to Inspections of Computerised Systems in Drug Processing, February 1983

This guideline of the National Center for Drugs and Biologics does not primarily address the industry but is intended as a training aid for FDA inspectors. Although no longer completely up to date, it is of interest to all who are responsible for hard- and software.


FDA Glossary of Computerized System and Software Development Terminology

This 60 pages document serves as a glossary of terminology applicable to software development and computerized systems in FDA regulated industries.


Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs

Japanse requirements on computerized systems


Questions and Answers regarding "Guideline on Management of Computerized Systems for Marketing Authorisation Holders and Manufacturers of Drugs and Quasi-drugs

Questions and answers regarding computerized systems



This document addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the Food and Drug Administration (FDA).


PIC/S Good Practices for Computerised Systems in Regulated "GXP" Environments (PI 011-3) Sept 2007

It is acknowledged that the field of computer technology continues to develop at a considerable speed and the regulated user has to ensure that the software has been developed to best software engineering practices in a quality assured manner. This document sheds some light on the techniques and controls required for this.


FDA Guidance for Industry: Part 11, Electronic Records, Electronic Signatures: Scope and Application

This guidance is intended to describe the FDA's current thinking regarding the scope and application of PArt 11


FDA Guidance for Industry; Blood Establishment Computer Systems Validation in the User's Facility

FDA, is issuing this guidance to assist you, blood establishments, in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices.


APIC - Computer validation Guide, December 2002

This document provides guidance for the GMP-compliant use of computerised systems for the manufacture of an API or intermediate.


GMP Conferences by Topics

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