Computer System Validation

Our Computer System Validation experts have vast experience in this highly-regulatory sector with a particular expertise in the Pharmaceutical, Medical Devices and Biotech industries. We specialise in short term projects and will work with your staff to provide a bespoke compliant solution at an affordable cost.

We have demonstrated expertise and completed projects in;

  • Validation Change Controls
  • Spreadsheet validation
  • Manufacturing Control System (MCS) validation
  • Building Management System (BMS) validation
  • ERP Systems
  • Laboratory Equipment validation
  • Autoclave Validation
  • HVAC Heating Ventilation and air-conditioning
  • Logistics Systems validation
  • Environmental Room Qualification
  • Thermal Mapping Studies
  • Batch Report validation
  • eDHR (electronic Device History Record) validation

We have completed projects previously using the following SDLCs

  • V-Model
  • Waterfall Model
  • Agile methodology

We can assess your computer system's compliance or current validation status against regulatory and industry standards. Our services include generating the full set of validation documents to ensure compliance with:

  • GAMP 5 : Good Automated Manufacturing Practices
  • FDA 21 CFR Part 11 on Electronic Records & Electronic Signatures
  • FDA 21 CFR 210 and 21 CFR 211
  • EU GMP Annex 11 for Computerised Systems
  • EU GMP Annex 15 Qualification and Validation

We also take a Risk Based approach:

  • Utilise a risk-based approach to ensure compliant computerised systems
  • Generate and conduct risk assessments
  • Generate and conduct Failure Mode and Effects Analysis (FMEA)