Thursday   28-Nov-2024

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+44 (0)161 928 8239
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Our work in highly-regulated industries has given us in-depth experience of various validation standards and systems. In many cases we have worked closely with the client's own validation specialists to ensure that their expectations are met, if not exceeded.

We do not look on validation as a bolt-on extra to a project: rather, our company culture treats validation from the start as running through all project activities including system specification and design, coding and configuration, testing and commissioning.

Nor do we look on validation as a series of discrete events during the lifecycle of the project: we treat it as a process, and work hard at integrating it into all the above project activities.

Our approach to validation aims to bring the following benefits to our projects and consultancy work:

• In the case of pharma projects, timely FDA approval
• High quality solution that meets the client's requirements
• Reduction in project rework and product waste
• Avoiding a potentially endless "merry-go-round" of document commenting and revision

On larger projects we will appoint an in-house validation co-ordinator who will oversee all the validation activities associated with the project. Typically this will include:

• Agreement of Validation objectives at the outset
• Internal validation training where necessary
• Production of documents to a format and quality that satisfies both Intuitive's and the client's validation requirements
• Verifying that Internal and Witness (client) testing of the system satisfies key validation criteria
• Close liaison with the client's validation co-ordinator to ensure expectations are met
• Ongoing control of the format and issue of project documents, essential on a large project

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