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What are the areas of greatest risk for data integrity issues?

The following answer to the question “What are the areas of greatest risk for data integrity issues?” is taken from The Windshire Group’s webcast GMP Data Integrity Expert Panel Discussion”:

Dr. James Blackwell: My perspective on this is that you really need to look at your controls and your critical points around your product release decisions. So, when FDA talks about your critical controls, they are not referring to critical control parameters. They are talking about data that goes into the decision that you used to release a product.

So, you can do data mapping to look at where the risk points are. And some examples are those legacy lab instruments that are fully Part 11 complaint. You now have what is known as a hybrid system between paper systems and the lab system that creates some real risk points systems where people may change metadata or parameters and it’s not been caught, so I recommend having detailed procedures requiring people to document everything within a log, book, or form; controlled form in those cases.

Another example is filtered integrity testers. A lot of those legacy systems don’t meet today’s standards and need to be replaced. With that I’d like to take a different tact. I think one of biggest risks is if there is serious data integrity issues, some organizations may want to take this skeleton and try to bury in the backyard. But you really need to be proactive about these things and involve the Agency at the appropriate time and inform them. Some of that is required by law.

But I think being proactive is the best advice, and so if you look at FDA Guidance on this, let’s say you have a Warning Letter or observations, they recommend to review some of their guidance from the “Points To Consider For Internal Reviews And Corrective Action Operating Plan” June 1991 document, so that entails bringing in a third-party or a consultant to assist with those situations. But what they don’t speak to is business practices that mature organizations do- they recognize serious issues. They are proactive and address the issue by bringing in third parties to assist with remediation before it becomes a bigger problem.

Dr. James Blackwell, Ph.D. M.B.A. is the Founder and Principal Consultant of The Windshire Group. The Windshire Group offers “Comprehensive CMC and Management Consulting”sm to the regulated life science industry. For further information, please contact; (+1) 844.686.5750


  • For a free download of the entire webcast recording click here
  • To read the complete free transcript click here

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