Computerised System Validation

Information about the various stages of the system development life cycle (SDLC).

Below are various stages of the system development life cycle (SDLC). There are also other articles in the chromatography data system and validation of spectroscopy software sections that compliment those on this page. 21 CFR 11 is covered in a separate section of the Library.

Writing user requirements is the pivotal stage of the life cycle as mistakes made here are magnified during later stages of system development and implementation. Find out here how to write user requirements.
A two-part paper on how to conduct vendor audits.
A discussion of spreadsheet validation co-authored with Chris Burgess and Bill Hardcastle.

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