Jackie has specialised in computer systems validation for the past 13 years, supporting a wide customer base in the Pharmaceutical and Medical Device sectors to comply with EU and FDA regulations, specifically EU Annex 11 & 15, 21 CFR Part 11. 

She has worked extensively on the implementation and validation of ERP systems (SAP, Oracle), Laboratory systems (LIMS, Chromatography, Lab equipment), and other GxP critical system such as Document Managment, CAPA/NCs, BMS, and Labelling applications.  She has an in-depth knowledge of IT infrastructure qualification using the GAMP guidance on IT Infrastructure Control and Compliance.  The risk based approach to validating applications and infrastructure aligns with the GAMP 5 Risk based approach to Compliant GxP Computerised systems.

Principal Consultant