Validation of computer systems in compliance with FDA (21 CFR Part 11) and EU (Annex 11 & 15), managing all aspects of the computer systems lifecycle.


Validation of Medical Device Software in compliance with EN IEC 62304:2006 Medical Device Software.


Qualification of IT Infrastructure as per GAMP 5 guide 'IT Infrastructure Control and Compliance'.


Spreadsheet Design and Validation to comply with security and audit trail requirements of 21 CFR Part 11 and EU Annex 11.


Project Management to manage all aspects of systems life-cycle from system selection through to systems implementation.