1. http://www.fda.gov/ora/inspect_ref/igs/csd.html

    Guide to Inspection of Computerized Systems in Drug Processing. This is from 1983 but is still worth reading as an historical document.

  2. http://www.fda.gov/ora/inspect_ref/igs/gloss.html

    Glossary of Computerized System and Software Development Terminology.

  3. http://www.fda.gov/cder/esig/part11.htm

    Information on Electronic Signature regulations which came out last year.

  4. http://www.fda.gov/cdrh/comp/swareval.html

    General Principals of Software Validation - Draft Guidance. Medical Device Software Validation. Specifically addresses medical devices, but written based upon good software development practices and therefore applicable to other computer software.

  5. http://www.fda.gov/ora/compliance_ref/rpm_new2/contens.html

    FDA/ORA Regulatory Procedures Manual, August 1997. Chapter 4 explains the process for issuing warning letters.

  6. http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=21

    Title 21 Code of Federal Regulations (21 CFR xx).