Barry McManus

Barry is a Principal Consultant for Empowerment Quality Engineering ltd, a boutique Computerised System Validation consultancy with vast experience working within both IT and Quality; given them the unique advantage of being able to “talk” both side’s language and bridge the gap between IT and Quality.

Barry focuses on building quality and security into Computerised Systems (CS) by using quality techniques from the wider software engineering practices whilst ensuring regulatory compliance. He leads GxP Computerised System (CS) Validation compliance and IT Supplier/Service Provider audits across the globe; performs IT supplier’s software lifecycle process improvement; risk assessments to drive Validation strategies and tailored training.

Barry has over 23 years’ experience in Software Engineering and IT Administration, possessing extensive technical knowledge of every role and every activity within the Computerised System Lifecycle, including development methodologies (traditional and agile), databases and programming languages across multiple technologies. He moved into the regulated industry in 2003 to commence management roles in QA, QC and CS validation. His approach resulted in delivering risk based, on time, right first-time CS validation projects. His experiences ensure that technical and regulatory risks do not compromise CS validation projects, delivers “value add” CS validation documentation and GxP compliance.

He is a member of the RQA’s I.T. committee (providing CSV training, articles and presentations) and a member of the ISPE Data Integrity Project team, authoring appendix 6, requirements Planning, of the GAMP Data Integrity GPG.

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