In another article, we explained what 21 CFR Part 11 is, covered a few examples, and the penalties for being out of compliance during a FDA audit.
And at the end, we touched on the four preventative measures that any manufacturing operation can take to stay in compliance.
Those preventative measures being:
Access Controls: Ensuring only authorized individuals can access critical data.
Audit Trails: Maintaining secure, time-stamped records of data creation, modification, and deletion.
Validation and Verification: Regularly validating electronic systems to confirm reliability and accuracy.
Data Integrity and Security: Securing data storage, transmission, and archival to prevent loss or corruption.
Which probably sounds like it's going to be a huge undertaking.
Especially with challenges that legacy instruments, strict regulatory requirements and data integration present.
Well...
It USED to be...
But it’s not anymore.
Now it’s actually quite simple…
Because we’ve created a solution that allows you to install all of these preventative measures into your operation to become 100% 21 CFR Part 11 Compliant…
Without making ANY changes to your SOPs.
Our solution, Digital Air, checks all of the compliance boxes by:
Restricting access to critical data and available actions based on the role of each user
Maintaining continuous audit logs of all activity on the air particles counter or other instruments, and all of the user activity on our platform… (Even maintaining detailed logs for incomplete and aborted samples.)
And the ability to remotely start samples and review their results with an electronic signature in accordance with 21 CFR Part 11.
Being compliant has never been this easy.
But before you ask…
Yes, it works regardless of what air particle counters you have…
Whether you have Met One air particle counters…
Or a mix of the Climet and Lighthouse air particle counters.
And can help you avoid costly penalties and hits to your manufacturing process.
If you want to see how much you can potentially save from mitigating risk associated with FDA audits…
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