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.
Glossary
FDA Glossary on Computer and Software
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Part 11 FDA Industry Draft Guidance on Validation
This draft guidance has been withdrawn form the FDA Website as part of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
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.
1997
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
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
FDA Compliance Policy Guide
Computerized Drug Processing; Identification of Persons on Batch
Production and Control Records, (CPG 7132a.08)
Reissued 1987
FDA Compliance Policy Guide
Computerized Drug Processing; Applicability To Hardware and Software
(CPG 7132a.11)
Revised 1987
FDA Compliance Policy Guide
Computerized Drug Processing; Vendor Responsibility (CPG 7132a.12)
Revised 1987
FDA Compliance Policy Guide
Computerized Drug Processing; Source Code for Process Control
Application
Programs (CPG 7132a.15)
Revised 1987
FDA Compliance Policy Guide
Sec. 460.400 Computerized Prescription Recordkeeping by Pharmacies
(CPG 7132b.09)
1980