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GxP Considerations for Compliance in the Cloud
Software as a Service (SaaS) is a cloud computing delivery model that promises various benefits, but also comes with unique risks. The life science sector has very slow cloud adoption rate. One of the potential reasons for this phenomenon, as highlighted by GAMP Cloud Special Interest Group (SIG ) is the lack of regulatory and industry guidance specific to the subject. Having reviewed the available guidance, this paper proposes the main GxP considerations associated with implementation of a SaaS system, to support GxP process including manage, store, and archive GxP data, and resolves them into a conceptual risk-based model.
M.SC in Pharmaceutical Validation Technology, TU Dublin
Shanmugapriya Shanmugam is an ASQ Certified Software Quality Engineer based in the UK and is currently studying the master’s degree programme, MSc in Pharmaceutical Validation Technology at TU Dublin. Shanmugapriya also holds a bachelor’s degree in Biomedical Engineering. Shanmugapriya has five years’ experience in the medical device industry covering computerised system validation. She has successfully delivered various cost improvement projects and process improvement activities. She also has over four years’ experience in the software industry where she had experience working with cloud based electronic data capture application.
Principle Consultant, GMP Services Ltd
Valerie has a deep interest in the future role of the Pharmaceutical Quality System and, in particular, the role of Quality Risk Management (QRM). She is currently researching a Ph.D. with the PRST (Pharmaceutical Regulatory Science Team) in TU Dublin. Her research interest is in developing a model for demonstrating the effectiveness of QRM in manufacturing operations. The Bow Tie article was written in the context of her research on moving the emphasis from reactive to proactive pharmaceutical quality management. www.gmp.ie