Articles that discuss the selection and validation of chromatography data systems (CDS) in the regulated analytical laboratory.
Information about the various stages of the system development life cycle (SDLC).
Bob's thoughts on the Electronic Records And Electronic Signatures 21 CFR 11 regulation and its interpretation.
Some of Bob's articles on the subject of Laboratory Information Management Systems (LIMS). Bob is the 1997 LIMS Awardee from the LIMS Institute based in Pittsburgh, PA, USA. Bob also edited the first book on the subject in 1987.
Laboratories have to work electronically if they are to survive. Therefore the paperless laboratory is an imperative.
Qualification of analytical equipment is a key regulatory compliance issue within regulated laboratories.
Articles and book chapters written by Bob over a number of years.
Risk management in computer validation is a hot topic since 2003 and the publication of the FDA's Part 11 Scope and Application guidance for industry stated "we recommend that you base your approach on a justified and documented risk assessment".