The Drug center’s memo on medical gas manufacturing and distribution has a short section stating a requirement for computer system validation and providing some references. The excerpt is below and the full memo is at the link provided:
COMPUTER SYSTEMS VALIDATION
All computer systems are required to be validated. Before a firm converts any of its manual operations to an automated operation that will be controlled by a computer system and associated software, it is required to validate the computer system and associated software.
According to the Guideline on General Principles of Process Validation, May 1987, validation is defined as establishing documented evidence which provides a high degree of assurance a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
Computer Validation references:
Micron Video International, Inc. – Videocassette ‘The GMP of Validation Understanding Validation’ (Module No. GMP/M-083), telephone number 1-800-5-Micron or 336-294-7116. Some of the areas addressed are: What is validation? Why & when to validate; Definitions; The principles of validation; Positive benefits; Validation Methods; Validation plans and protocols; Qualification explained; Validation of computer controlled systems; and 3 case studies.
Good Computer Validation Practices – Common Sense Implementation by Teri Stokes, Ronald C. Branning, Kenneth G. Chapman, Heinrich Hambloch, and Anthony J. Trill, Interpharm Press, Inc. (303)754-3953 or (303)662-9101.
PDA Journal of Pharmaceutical Science and Technology, Technical Report #18, 1995, Volume 49, Number S1, Validation of Computer-Related Systems.
Pharmaceutical Engineering, July/August 1995, Computer Systems Validation: A Historical Perspective by Dr. Guy Wingate.
Pharmaceutical Technology, March, April & May 1992, GMP Documentation Requirements for Automated Systems: Part I, II, & III, respectively.
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SoftwareCPR keywords: Drug, OTSS, process validation