Please contact Ennov PV support for the latest validation documentation

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Validation white paper

Validation

Pre-validated software and environment to accelerate implementation

In the regulated environment of the pharmaceutical industry, there is a clear expectation that all software used is ‘validated’. In simple terms:

  • It has to be demonstrably proven that any software used meets and will continue to meet its predetermined specification
  • The software will be used within a managed, documented environment by qualified, competent staff

In Assured’s SaaS model, we act as your IT Function and take responsibility for the functionality and quality of the software and its operational environment, leaving you to concentrate on pharmacovigilance.

The PV247 solution (including its PV-Works software) and the technical environment are provided for you ‘pre-validated’. Establish your own working procedures and you are good to go.

In support of your use of PV247, we provide certification that it has been formally tested and installed according to predefined Standard Operating Procedures and that its ongoing use is secure.

We ensure our software always remains fit for purpose

ISO 9001:2015 Quality Management SystemPV-Works is developed, installed and managed under an accredited ISO 9001:2015 Quality Management System and is designed to be operated in compliance with 21 CFR Part 11.

For further details please download our Validation white paper or contact us.