TRYON BLOG
The FDA is NOT FUNNY, But this is…
There is not a lot of funny business when it comes to compliance in the warehouse, but to stay on top of the FDA 21 CFR Part 11 mandate, we’ve added a bit of flavor.
1. Know the Rules Like a Super Fan
Imagine the regulation is your favorite TV show. Binge-watch, memorize every plot twist (or paragraph), and make sure your team knows the difference between a valid signature and your 2-year-old’s scribbles.
2. Keep the Gates Locked
Think of your warehouse systems like a VIP club. Only authorized folks get in, and they better have the right password (no, “password123” doesn’t count). And yes, the bouncer (your system) needs to keep a list of who’s been in and out.
3. Make Sure Your Tech is Not a Drama Queen
Your systems should be as reliable as a drama-free friend—validated, tested, and trustworthy. Regularly check that they’re not throwing any tantrums (aka glitches) that could jeopardize your compliance status.
4. Signatures: Not Just for Autographs
Electronic signatures should be more secure than a celebrity’s autograph. Make sure your signatures are legit, and no one’s pretending to be someone else—unless you’re hosting a very exclusive masquerade ball.
5. SOPs: The Script for Success
Write SOPs like a screenwriter crafting a blockbuster. Every process should have a clear plot, no plot holes, and definitely no surprise endings (unless they’re FDA-approved).
6. Audit Like You’re Sherlock Holmes
Channel your inner detective. Regularly audit your systems with the thoroughness of Sherlock Holmes inspecting a crime scene. No stone—or record—should be left unturned.
7. Documentation: The Best-Seller You Didn’t Know You Were Writing
Treat your documentation like it’s the next big thing on the New York Times bestseller list. Make it detailed, compelling (to auditors, at least), and impossible to put down.
8. Stay Updated Like a Tech Savvy Grandma
Keep up with FDA updates like a tech-savvy grandma who’s always ahead on the latest trends. If the FDA drops a new rule, you’re on it faster than she is on the newest iPhone.
Is not fun to go through a food recall…and let’s hope it does not happen through your facility. If it does, checking and double checking processes before it happens can make it easier on you and your supply chain. For more direct information on the FDA’s Part 11, please click here!
Written By Jeff Constable
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