Our Services

Computer System

Computer System Validation

Our Computer System Validation highly-regulated experts have vast experience in this highly-regulatory sector with particular expertise in the Pharmaceutical, Medical Devices and Biotech industries

We’ve completed projects in:

  • Electronic Document Management System Validation
  • OSI PI Data Historian validation
  • Environmental Monitoring System validation
  • 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

We’ve completed projects using the following SDLCs:

  • V- Model
  • Waterfall Model
  • Agile Methodology

Validation Documentation

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 Computerized Systems
  • EU GMP Annex 15 Qualification and Validation
  • Utilise a risk-based approach to ensure compliant
    computerised systems
  • Generate and conduct risk assessments
  • Generate and conduct Failure Mode and Effects Analysis (FMEA)

Partner With us

We partner with companies that wish to offer products to the Life Sciences sector and guide them through the validation requirements to generate fully compliant solutions.

We work with you to create a proportional risk based roadmap
for your validation journey.