GxP Considerations for Compliance in the Cloud

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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.

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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

Principal Consultant, GMP Services Researcher PRST TU Dublin

Valerie Mulholland is the Senior Consultant with GMP Services based in Ireland.
For over 20 years she has provided Regulatory and Compliance Intelligence, including training & auditing services to the biopharmaceutical, pharmaceutical, medical device and blood transfusion industries.
She is a researcher with the Pharmaceutical Regulatory Science Team (PRST) in TU Dublin.
Valerie’s own area of interest is decision making within QRM and the PQS, and she provides training and consultancy on risk-based decision-making.
She is the current secretary of the Irish Chapter of the PDA, engaging with regulators and industry experts on topical areas of interest across the biomanufacturing industry.
She is a co-host of the Risk Revolution Podcast.
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