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FDA Guidance for Computer Systems

Software and computer systems used in FDA regulated environments should be well controlled and validated. While there is not much detail in FDA regulations the agency has developed many guidance documents.


FDA Industry Guidance:

Computers in Clinical Trials - 2007

Final version published in May 2007, this document shows the agency's most current thinking on computer validation and part 11 compliance for all FDA regulated industries, not only for clinical studies.



FDA Glossary on Computer and Software (check Google)

This glossary is recommended when you define terms and develop glossary for your own organization.


FDA Guidance - Medical Device

FDA Principles of Software Validation

The guidance has been developed mainly for development of software for medical devices. However, it is a quite useful reference for other software development activities.


FDA Guidance - 21 CFR Part 11

Part 11 FDA Industry Draft Guidance on Validation

This draft guidance has been withdrawn form the FDA Website as part of the drug CGMP initiative for the 21st century. However, most of the statements in the guidance are still very much appropriate and subject to FDA inspections. The guide is especially useful for users of computer systems.


FDA Training Manual for Inspectors

FDA Investigational Training Manual

This chapter 22C of the FDA investigational training manual has been developed for FDA inspectors as a guidance on how to inspect computer systems. The manual has been developed in the 90's and looks rather old but the basics are very much up-to-date and strongly recommended to be followed in preparation for FDA audits.


FDA Guidance for Industry and Reviewers

Off-The-Shelf Software Use in Medical Devices

This guidance document was developed to address the many questions asked by medical device manufacturers regarding what they need to provide in a pre-market submission to the FDA when they use off-the-shelf software (OTS). This document lays out in broad terms how the medical device manufacturer can consider what is necessary to document for submission to the agency

September 1999


FDA Inspection Guide

Guide to inspections of computerized systems in the food processing industry (search Google)

This document is intended to serve as a resource for FDA investigators who conduct inspections of regulated food firms that use computers and computer software to control operations and record data that may affect the safety of the finished food product.


FDA Reviewer Guidance for Premarket Notification

Submission for Blood Establishment Computer Software

This guidance applies to software products intended for use in the manufacture of blood and blood components or for the maintenance of data that blood establishment personnel use in making decisions regarding the suitability of donors and the release of blood or blood components for transfusion or further manufacture.



FDA Office of Regulatory Affairs Compliance References: Bioresearch Monitoring (BIMO) Compliance Program 7348.808

Attachment A: Computerized Systems

The intent of this attachment is to collect, in one place, references to computer systems of the program.


FDA Inspection Guide

Guide to inspection of computerized systems in drug processing (search Google)

The purpose of this guide is to provide the field investigator with a framework upon which to build an inspection of drug establishments which utilize computer systems. This document is not intended to spell out how to conduct a CGMP drug inspection or set forth reporting requirements, but rather what aspects of computerized systems to address during such inspections and suggestions on how to address the systems.

February, 1983 (Blue Book)

FDA Compliance Policy Guide

Computerized Drug Processing; Input/Output Checking (CPG 7132a.07)

Reissued 1987 (search Google)


FDA Compliance Policy Guide

Computerized Drug Processing; Identification of Persons on Batch Production and Control Records, (CPG 7132a.08) (search Google)

Reissued 1987


FDA Compliance Policy Guide

Computerized Drug Processing; Applicability To Hardware and Software (CPG 7132a.11)  (search Google)

Revised 1987


FDA Compliance Policy Guide

Computerized Drug Processing; Vendor Responsibility (CPG 7132a.12)
(search Google)

Revised 1987


FDA Compliance Policy Guide

Computerized Drug Processing; Source Code for Process Control Application
Programs (CPG 7132a.15) (search gogle)

Revised 1987


FDA Compliance Policy Guide

Sec. 460.400 Computerized Prescription Recordkeeping by Pharmacies
(CPG 7132b.09) /search Google)