Service
Computer system validation and data integrity
We validate manufacturing, laboratory and quality systems and design data integrity controls into them from the start.
We validate manufacturing, laboratory and quality systems to ISPE GAMP 5 and 21 CFR Part 11, with data integrity controls designed in rather than added at the end.
Our engineers work across control systems, manufacturing execution systems and laboratory systems, so validation is planned with the people who configure and run them.
What we deliver
- Validation master plans
- User requirement and functional specifications
- Risk assessment to ISPE GAMP 5
- Installation, operational and performance qualification for computerised systems
- Data integrity assessment against ALCOA+
- Audit trail and access control review
- Periodic review and change control
- Validation summary reports
At handover
What you receive
- Validation master plan
- User requirement and functional specifications
- Data integrity assessment against ALCOA+
- Traceability matrix from requirements to testing
- Validation summary report
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View serviceDiscuss your project with an engineer
Tell us the scope, the site and the timing. A director will reply within one business day.