Any FDA regulator worth their pay breathes a sigh of relief when they monitor pharmaceutical manufacturers that use widely recognized and standardized integrated business systems known to be adapted for FDA 21 CFR Part 11 compliance.
 

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Home > Resources > White Papers > Risky Business: Taking a Look at Manual v Automated

Risky Business: Taking Another Look at Manual v Automated Compliance

Time to take another look at automating FDA compliance? “Gosh”, you say, “need we or any pharmaceutical manufacturer look any further than the mountains of forms we fill out hourly in order to get an order out the door?”

YES, it’s time to take another look at compliance because the FDA’s swelling ranks give you new reason to do so. This means even more FDA inspectors fully schooled in the 21 Code of Federal Regulations (CFR) that pharmaceutical firms must live or die by.

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The Key Competency for Growth
Optimizing information and collaboration will be the new key to winning or losing in Pharma.
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The following pages provide a table mapping of 21 CFR Part 11 sections to the Microsoft relevant technologies that can assist with compliance.
Pharmaceutical Processing: Lots More Than Tracking!
Think that because you have strong controls for lot tracking and traceability you are fully compliant with FDA CFR 21 Part 11? Think again!
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