Process Control Computerised System
Do you need process control system validation on a new single piece of equipment? Perhaps you need a distributed control system? Does your company have a process on another site and you want to bring a new scale to yours? Do you use manual processes that you think, I want this automated? Has your site already purchased a new piece of equipment that needs validation quickly?
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 manufacturing process 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 manufacturing area:
- 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 experienced Automation-based CSV resource, 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.
