Bioanalysis Zone

Chapter 6: Computerized system validation

Doi: 10.4155/FSEB2013.14.147


RD McDowall
Director, R D McDowall Limited
73 Murray Avenue
Bromley, Kent BR1 3DJ, UK
Phone: 020-8313-0934

About the Author

Bob McDowall has a PhD in forensic toxicology, 15 years’ bioanalytical expertise in two major pharmaceutical companies and for the past 20 years has been a consultant running his own company. He was one of the eight co-chairs of the first Bioanalytical Methods Conference in 1990 and the only European co-author of the subsequent published paper. Bob has over 30 years’ experience with laboratory informatics, automation and computer validation; he was the editor of the first book on laboratory information management systems (LIMS) in 1987. He has written many papers on the topic of laboratory informatics and taught at many scientific conferences. He was presented with the 1997 LIMS Award from the LIMS Institute for his contribution to advances in the subject as well as his teaching on the topic.

Computerized system validation


Computerized system validation (CSV) demonstrates that a software application together with any interfaced instrumentation is capable of performing its pre-defined functions and is fit for its intended use. In addition, CSV is also a means of protecting the investment of a laboratory in ensuring that the right system is purchased for the right job. Validation is not a difficult job, it is merely good software engineering practice with a compliance wrapper for the regulated GXP bioanalytical laboratory. Risk assessment is used throughout the system life cycle to help focus scarce resources where they are best used.

Regulatory and industry guidance for computerized system validation

The main regulatory guidance for computerized system validation (CSV) has come from the GMP area of the pharmaceutical industry followed by GLP and then GCP. The best CSV guidance comes from the good automated manufacturing practice (GAMP) guide [1], which has a risk-based approach to computer validation. There is a companion Good Practice Guide (GPG) on Risk-Based Validation of Laboratory Computerized Systems (second edition) that has more information specifically for laboratory systems [2]. Practical GLP guidance is lacking either because it is out of date, as in the OECD GLP consensus guidance [3], or the Drug Information Association (DIA) guidance, which lacks a risk-based approach and is too onerous to consider implementing [4]. The Swiss (Arbeits Gruppe fur Information Technologie / Working Group for IT) AGIT guidance on validation (second edition) [5] tries to blend the DIA document with United States Pharmacopoeia <1058> on Analytical Instrument Qualification [6] but is too simplistic and leads to compliance gaps for the laboratory. For more detail on the GLP and GCP regulations as well as regulatory guidance from regulatory agencies and industry bodies see the author’s review paper on computerized system validation in Bioanalysis [7].

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