Computer System Validation Templates / Protocols
What’s included in this pack of GAMP 5 validation templates?
Pack includes the computer system validation templates for developing Plans, Specifications, Protocols and Reports in accordance with FDA, EMEA and PIC/S requirements for Computer system validation and most importantly, adopts the latest thinking on a risk based approach to computer systems validation, as prescribed in Part 11, or Annex 11 and as recommended in GAMP 5 and other validation methods. However these templates are specific to, and are considered to be GAMP 5 validation templates.
The following templates are included:
- Validation Master Plan (VMP)
- User Requirements Specification (URS)
- Risk assessment tool
- Functional Specification (FS)
- Design Specification (DS)
- Design review or design qualification
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
- Validation summary report (VSR)
Take a preview – here’s an extract from the template pack
Get a head start with our unique “built in” requirements traceability document structure
This ideal resource whether you use the short or extended pack, our documents have a “built in” requirements traceability matrix saving you hours.
What is better is our “built in” risk assessment document structure
We have built in the risk assessment into the documents, so you can assess the risk at many levels, system, module, functional and elemental level. This structure ensures easy compliance with the regulatory requirement for a risk based approach and focuses scarce resources on critical areas.
Get help from our regulatory compliance experts
Included in the price is two hours of support via telephone or email. Feel
confident in the knowledge that if you have questions or get stuck then you can
speak to a GMP compliance specialist to set you on the right path.
Our consultants have many years of experience working in the pharma and medical device industries. You can benefit from their knowledge of what works and what doesn’t when creating and maintaining a pharmaceutical quality management system.