This chapter will provide an overview of how computer controlled or automated units are to be qualified and then validated as part of and included with process systems. Note that while each is discussed as operational units standing alone, they can and should be qualified and/or validated as part of the process equipment they are associated with when those units are qualified. This chapter is not intended to be a full tutorial on computer validation. The use of the terms “qualified” and “validated” are used and applied, as they normally would be (ie, equipment—hardware is qualified; and the process—software working with the hardware is validated). Remember, when qualifying a computer controlled system you are also “validating” both the computer system and the process equipment. Both the structure and function of the computer and the process equipment are all to be done at the same time. The US Food and Drug Administration (FDA) considers computer systems as equipment 21 CFR 211.681 and thus needs to be formally qualified. The use of computerized control for manufacturing and quality control has grown substantially over the last few decades. The FDA has published guidelines on computer software validation (including Part 11).2 In addition, the GAMP3 (Good Automated Manufacturing Practice) guideline has been adopted as the standard for most computer systems validation (CSV) programs. There are five (really now only 4) levels of systems according to the GAMP 54 guide, these are:
Introduction
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
Introduction
• Category 1—Infrastructure Software—Operating systems, database managers, statistical programing tools, and programming languages.
