Nichola Stevens

Nichola is the owner of and Principal Consultant at Nuncius Compliance Solutions Ltd. In this role Nichola helps companies improve overall IT Quality and achieve effective regulatory compliance by performing gap assessments, data integrity evaluations, supplier audits, etc., and proposing and overseeing prioritized remediation activities.

Previously Nichola was the Global Director of Computer System Validation at Alere (now part of Abbott). In this role Nichola was responsible for ensuring that Alere had, and applied, the necessary standards, processes and procedures to deliver high quality, validated computerized systems and to maintain those systems in a compliant manner. This included identifying and managing risks (e.g. cloud computing, outsourcing, data integrity, data center migrations, etc.) that might impact the GxP compliance of Alere’s computerised systems.

Nichola started her career in R&D as a chromatographer with SmithKline Beckman before moving to Oxford Asymmetry International, gaining a first experience of validation. Further experience was gained at Covance before Nichola joined Mi Services as a validation consultant. . Prior to joining Alere, Nichola worked for AstraZeneca as the Global GxP Subject Matter Expert within IT.

Nichola is the Chair of the GAMP UK Steering Committee, a member of the GMP Europe Steering Committee, and a member of the RQA IT Committee.

Barry McManus

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 and security 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/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 with vast technical knowledge of every role and every activity within the Computerised System lifecycle; 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, the DIA IQCT community core team and a member of the ISPE Data Integrity Project team.

Joe’s career in the regulatory industry started as an Apprentice Laboratory Technician in an Environmental Risk Assessment laboratory in 2011. His time as an Apprentice led to him being awarded the first “Chemical Sciences” Apprentice of the Year by the Royal Society of Chemistry and “Advanced Apprentice of the Year” for the Yorkshire and Humber region.

Joe has worked in the regulatory industry for the last 15 years on a wide range of projects, from carrying out and managing regulatory environmental risk assessment studies to designing, building, and managing bespoke regulatory projects and facilities.

Joe has worked on Computerised Systems Validation (CSV) for the last 13 years; during this time, he has developed and implemented new ways of working within the regulatory environment, including implementing the risk-based life-cycle approach to CSV. He has carried out numerous CSVs on a variety of instruments, from simple systems such as spectrophotometers to more complex systems such as radio-labelled chromatography systems (HPLC, GCMS, LCMS) and LIMS and application development, including AGILE.

Joe now runs his own Validation and Data Integrity Consultancy which focuses on establishing risk based approaches for small to medium sized companies who want practical and logical solutions to their challenges.