Date Published:
Wed, 03/01/2006March, 2006 guidance on using e-mail, fax, and text messages to report product recalls.
Regulations and Guidance
FDA Guidance: Part 11, Electronic Records; Electronic Signatures — Scope and Application
Date Published:
Thu, 08/28/2003August, 2003 guidance on 21 CFR Part 11 scope of application, enforcement focus areas, and a risk based compliance approach.
FDA Glossary of Computerized System and Software Development Terminology
Date Published:
Wed, 04/30/2003Reference list of computer and software terms with definitions from IEEE, ANSI, ISO, NIST, NBS, and various other sources
FDA 21 CFR 11: Electronic Records; Electronic Signatures and Preamble
Date Published:
Thu, 03/20/1997FDA Preamble and regulation on electronic records and electronic signatures.
FDA Guidance: Contents of Premarket Submissions for Software Contained in Medical Devices
Date Published:
Wed, 05/11/2005May, 2005 CDRH guidance to industry regarding software used in medical devices and software at blood establishments. This guidance contains sections on software documentation, risk assessment & management, software change management, software of unknown pedigree (SOUP), virus protection software, and interfaces, networking, and network infrastructure.
FDA Guide to Inspection of Computerized Systems in Drug Processing
Date Published:
Tue, 02/01/1983February, 1983 guidance to inspectors regarding how to audit system hardware, software, networks, and procedures
FDA ORA Laboratory Manual: Basic Statistics and Data Presentation
Date Published:
Wed, 10/01/2003October, 2003 ORA reference for lab analysts. Note section 4.5 on spreadsheet validation.
FDA Guidance: General Principles of Software Validation
Date Published:
Fri, 01/11/2002January, 2002 CDRH guidance on how to validate software used to design, develop, and manufacture medical devices. Also note section 6 on validation of process equipment and quality system software.
FDA Pharmaceutical CGMPs for the 21st Century - A Risk Based Approach
Date Published:
Wed, 09/01/2004September, 2004 report on the FDA's modernization programs. Contains an update on 21 CFR Part 11 approach.
FDA Guidance: Off-The-Shelf Software Use in Medical Devices
Date Published:
Thu, 09/09/1999September, 1999 CDRH guidance regarding OTS software in device documentation needs, hazard analyses, hazard mitigation, and 510(k), IDE, and PMA issues.
