Laboratory Equipment Computer Systems Validation (CSV)
Do you need computer system validation? Does your laboratory have a paper based analysis reporting & archive system? Do you use spreadsheets to calculate and/or report results? Has your laboratory purchased a new piece of equipment?
If any of the answers above are yes, then yes you need CSV!
In a world becoming increasingly reliant on computer systems for generating, reporting and storing analytical results and information the need for CSV has never been more important. Cheshire Scientific Services only validate systems to the current 21 CFR Part 820, 21CFR Part 11/ EU Annex 11 & GAMP5 standards , providing any of the below requirements for your laboratory:
- Software Validation Protocol
- System/Software Requirements Specification
- Network Diagram
- Risk Analysis and 21CFR Part 11/EU annex 11 compliance analysis
- Design & Functional Specification
- Full validation protocol generation, execution or review
- Requirements Traceability Matrix
Cheshire Scientific Services can provide a tailored validation approach for your chosen electronic solution no matter the GAMP category
If you need an electronic upgrade for your laboratory process or analysis, allow one of our specialists to guide you through from start to finish on how to make a seamless transfer from your current way of working to an easier, reliable, electronically compliant solution.
