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I have started this blog to discuss the latest in computer systems validation and regulatory requirements within the pharmaceutical and biotechnology industries.

I have extensive experience in the design, implementation and validation of computerised systems within the pharmaceutical (primary and secondary manufacture) and biotechnology sectors.

Control Systems
  • Finesse TruBio System (based on DeltaV Platform) for single use bioreactors (SUB)
  • PLC / SCADA based control systems including Siemens (S5 / S7), Allen Bradley (SLC500 / Micrologix) and InTouch SCADA Systems.
Validation Lifecycle Experience
Implementing a Risk Based approach to validation (in accordance with GAMP 4 / GAMP 5)
  • Validation Plans
  • User Requirements Specifications
  • Design Documentation and Design Reviews
  • Risk Assessments (Component / Functional)
  • Testing (FAT / SAT / Commissioning / Installation Qualification / Operational Qualification)
  • Validation Reporting
As the validation area lead for computerised systems within the biotechnology area I have extensive knowledge of regulatory requirements and industry guidance including:
  • cGMPs – 21 CFR 210 / 211 - ICH Q7
  • EU GMP including Annex 11 / 15
  • Electronic Records and Signature (21 CFR Part 11) including implementation of a risk based approach following FDA Final Guidance and ISPE industry guidance
  • GAMP 5 - Including developing risk based strategies to validation of process control systems
  • ASTM 2500 Guidance
For more information about me see my LinkedIn Profile