I agree with @julienneniuya and @asimbana that Verification is to confirm that design outputs equals the inputs. That the design numbers/specs set out are accomplished whereas with validation is the confirmation on the end user that the device meets the user needs. When researching industry validation processes, I came across a New York Times article from a couple weeks ago, where a company called Box, Inc. (NYSE:BOX) announced Box GxP Validation, which is an innovative new approach for maintaining GxP compliance in the cloud. Box GxP Validation enables Pharmaceuticals, Biotechnology and Medical Device businesses to develop, validate and operate their GxP compliance standards within Box. As Riju Khetarpal, Managing Director, Box for Life Sciences says “With GxP Validation, companies in regulated industries can eliminate inefficient silos between regulated and unregulated information, and speed up collaboration and innovation”. Some capabilities include:

-Exchange clinical content between sponsors, Clinical Research Organizations (CROs), contract manufacturing organizations, and investigator sites;
-Collaborate and exchange regulated content during joint development or M&A activities;
Secure archival of Standard Operating Procedures (SOP) and clinical study documentation;
-Remain compliant with 21 CFR Part 11 requirements by integrating Box with an eSignature provider of choice, like Adobe Sign and DocuSign;
-Leverage Box as a compliant content layer with life sciences ISV and SI partners.

Box customers include: Eli Lily, AstraZeneca, Jazz Pharmaceuticals and Boston Scientific. Overall, I thought it was interesting to think about validation processes and thinking about how these larger life science companies are purchasing products like this. It’ll be interesting to see if the larger medical device companies follow suit.

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