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Life Sciences

The Trifecta Of Validation


Admit it – you cringed a little. It’s almost like a dirty word in our industry. That thing that slows down system implementations. That thing that adds a bunch of time and cost to IT projects. That annoying, but necessary, evil.

Well, okay, it’s not really “evil,” per say. It is, after all, designed to protect the health and safety of the patients we serve, and it is required by the FDA. But, I agree that it can be a real pain.

Since we in the life sciences space are in the business of reducing pain, I thought I’d share a few methods that Perficient employs to make validation less of a burden:

  • Risk-Based: We don’t require the same validation effort for every single system. Instead, the first step we take in any implementation project is to assess the risk that the system poses. Then, based on that result, we follow the process laid out for a system with that risk level.
  • Procedure-Based: Our SDLC procedure is ENORMOUS, but that’s because it explains the process for each system risk level: low, medium, and high. Once you have your risk level, all you have to do is go to the corresponding section in the SDLC and follow the process. It even lists out who needs to author, review, and approve each deliverable.
  • Template-Based: We maintain an extensive library of templates for all of the document deliverables described in our SDLC procedure. Each template contains instructions for use, as well as a great deal of boilerplate and sample text. Our templates also make use of Microsoft Word’s “document property” functionality, which allows us to update text that is used throughout the document (e.g., company name, application abbreviation, application version) in a single place and have it automatically update throughout.

What makes these methods the “trifecta of validation” is the consistency they create. Not only do they make it clear and easy for us to know what to do and how to do it during a project, they help us stand up straight in an audit. They enable us to demonstrate a consistent approach across the board for systems of each risk level, which goes a long, long way with auditors.

If you’re interested in identifying ways to streamline validation or improve the audit experience at your organization, contact us.

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Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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