GxP Considerations for Compliance in the Cloud

ABSTRACT

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.

Shanmugapriya Shanmugam

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.

Valerie Mulholland

Senior Director / Principle Consultant, GMP Services Ltd

Valerie is currently researching a PhD in ‘Demonstrating the Effectiveness of Quality Risk Management in the Pharmaceutical Quality System’ and the focus of the research is risk-based decision making (RBDM).

She is an active member of the global QRM community and has spoken on the topic of RBDM at international industry conferences.

She is a principal consultant with GMP Services, providing compliance & regulatory intelligence – training, auditing, and consultancy – on risk, compliance, and quality systems.

She is Hon Sec of the PDA Irish Chapter and co-hosts a podcast called ‘The Risk Revolution’.

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