FSMA Fridays: The Top 5 FSMA Challenges And What You Should Be Doing To Prepare (Part Three Of Four)

Check out Part 1 and Part 2 of this series

In the second portion of FSMA Fridays: The Top 5 FSMA Challenges And What You Should Be Doing To Prepare, Levin and the Acheson Group panel discussed supply chain control concerns regarding FSMA. He also explored what testing protocols food makers will need to follow upon FSMA’s implementation. Here, in part three of the series, Levin and the Acheson Group panel will discuss the requirements of recordkeeping within FSMA and what companies should be doing now to prepare. The panel also begins answering questions from the webcast’s live audience.

Barbara: Melanie, for the fifth of the challenges of the top 5 that we were discussing today, what should companies be doing now to determine their record keeping requirements for the FDA?

Melanie: Well Barbara, that is one of the greatest questions, I think, because that is the area that companies are likely to get the most tripped up on. David mentioned, just in the last question, that testing is going to require a lot of documentation. So, there’s going to be just mounds and mounds of documents that are going to be generated as a result of FSMA, these FSMA rules, and the requirement to be FSMA compliant. So, how are companies going to manage all of this data and all of this documentation?

Certainly, the days of the filing cabinet are over. If companies think that they’re going to be able to stay on top of all of the documentation in a paper-based way, I think that, if I can be so bold, are dreaming. It’s going to be really hard to do that in the manual environment and I think companies would be really-well served to look for an electronic or technical means to manage their data because of all the requirements under FSMA, not to mention the rest of the FDA requirements.

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