Computer System Validation Templates / Protocols

$900.00 US

Built in Microsoft® Word for easy editing, these templates are the quick and easy way to build a your computer system validation protocols.

The templates are used by our consultants in the field and are full of practical guidance and how-to instructions. They are easy to use and will save you weeks, if not months, of time.

Ideal for startup pharmaceutical or life science companies who must comply with PIC/S (TGA) or FDA GMP guidelines.

We offer a simple series of templates that can be scaled to suit your validation needs.

Description

Computer System Validation Templates / Protocols

What’s included in the CSV template pack?

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 recommended in GAMP 5.

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 wether you use the short or extended pack, our documents have a “built in” requirements tracability 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 requrirement for a risk based approach and focusses 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.

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