In 1992 the FDA published this guidance document to provide details on how to comply with the cGMP requirements associated with 21 CFR 820 for the manufacture of computerized medical devices and the control of computerized manufacturing processes and quality systems. This document was intended for use by FDA investigators.
PIC/S Guidance for validation, testing, life cycle management, change control, electronic signatures, security, back-ups, and inspection of computerized systems used in GxP environments.
The Inspections Operation Manual is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors.
Regulations affecting computer systems in the life sciences are spread over many different organizations and websites. Here you can access all the software compliance regulations and guidance information you need from the U.S. and Europe in one spot.
June, 2006 presentation by Joseph Formulare with content on FDA's application of a risk based models, quality by design, ICH Q10, and ICH Q7A.
FDA regulation from the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Contains references to 21 CFR Part 11.
FDA regulation on electronic records and electronic signatures.
June, 2006 CDER and CBER issuance of the ICH Q9 quality risk management document. Note Annex II section II.4 on how a risk based approach can be applied to computer validation.
ORA guidance to inspectors regarding how to audit system hardware, software, networks, validation, maintenance, and procedures.
