Our Services
Computer System Validation
Computer System Validation
Our Computer System Validation highly-regulated experts have vast experience in this highly-regulatored 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
- Manufacturing Control System (DeltaV) Validation
- Environmental Monitoring System Validation
- Pure Steam Generation System Validation
- Spreadsheet Validation
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 Computerised 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)
Other Services
-
Qaulity Auditing
Safeguard your facility against statutory regulations
Read More -
48 Hour Review
Rapidly assess your validation deliverables within 48 hours
Read More -
21 CFR Part 11
Protecting the electronic data within your systems by ensuring it is compliant with 21 CFR Part 11 regulations
Read More