Direct Links to important GMP Computer Validation Guidelines

APIC - Technical Change Control Guideline 2004 (October 2004)

This document provides guidance on change control procedures for equipment, utilities and computerised systems in API facilities.

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FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations

This document provides to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and institutional review boards (IRBs), recommendations regarding the use of computerized systems in clinical investigations

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“Computer Crossmatch” (Computerized Analysis of the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type)

This guidance describes certain of the practices that FDA, believes satisfy the requirements in 21 CFR 606.151 to help ensure detection of an incompatible crossmatch when using an electronic based system for matching a donor's cell type with a recipient's serum or plasma type

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FDA Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility DRAFT GUIDANCE

This guidance addresses a blood establishment's validation of its Blood Establishment Computer System which incorporates Blood Establishment Computer Software (BECS). The BECS that is incorporated into a Blood Establishment Computer System may be manufactured either in-house or by a software manufacturer/vendor.

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Eudralex Volume 10 Annex III TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Computer Systems

GUIDANCE DOCUMENTS CONTAINING THE COMMON PROVISIONS ON THE CONDUCT OF GCP INSPECTIONS BY COMPETENT AUTHORITIES OF THE DIFFERENT MEMBER STATES

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Eudralex Volume 10 Annex V GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Phase I Units

The purpose of this document is to provide guidance for the preparation of GCP inspections conducted in Phase I Units. The points to consider in this document are specific to these types of units and other guidance documents should be referred to for consideration of those areas common to other types of inspections, e.g. computer systems, archiving and quality systems.

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EU GMP Annex 11: Computerised Systems

Supplementary guidelines to the EC-GMP Guide with specific requirements for computerized systems.

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FDA COMPLIANCE POLICY GUIDE Sec. 425.100 Computerized Drug Processing; CGMP Applicability to Hardware and Software (CPG 7132a.17)

Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.

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FDA COMPLIANCE POLICY GUIDE Sec. 425.200 Computerized Drug Processing; Vendor Responsibility (CPG 7132a.12)

Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.

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FDA COMPLIANCE POLICY GUIDE Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs (CPG 7132a.15)

Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.

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GMP Conferences by Topics

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