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Barry McManus, Principal Consultant 

Empowerment Quality Engineering Ltd

Barry is a Principal Consultant for Empowerment Quality Engineering ltd, a Computerised System Validation consultancy that bridges the gap between IT and Quality. 

Barry focuses on building quality into Computerised Systems (CS) by using quality techniques from the wider software industry while ensuring regulatory compliance. He leads GxP Computerised System (CS) Validation compliance and IT Supplier audits across the globe; performs IT supplier’s software lifecycle process improvement and risk-based CS Validation with the aim of optimising activities and reducing risk. 

Barry has over 22 years’ experience in software engineering with vast technical knowledge of every role and every activity within the Computerised System lifecycle; including multiple technologies, development methodologies, databases and programming languages. He moved into the regulated industry in 2003 to take up 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 beneficial CS validation documentation and GxP compliance. 

He is a member of the RQA’s DIGIT committee, a member of the DIA IQCT community core team and a member of the ISPE Data Integrity Project team.


Abstract

IT Supplier and CSV compliance audits across the globe reveal that Risk Management can be an inadequate and sometimes a liability in CSV projects. Taking security as a theme, this presentation will examine some simple techniques accrued from 22 years of experience across multiple industries to improve Risk effectiveness. This presentation will look at:

  • The issue of security facing IT systems
  • The current cost of poor Risk Management
  • The cost of poor security
  • Some simple risk techniques to build security in from the start.

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