FAQ Friday: E-signatures and 21 CFR Part 11 Compliance

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FAQ Friday: E-signatures and 21 CFR Part 11 Compliance

In 2007, the FDA set forth rules governing e-signature documentation known as 21 CFR Part 11. This is an important function in Good Manufacturing Practices. Here are a few frequently asked questions about how InstantGMP MES helps you comply with 21 CFR Part 11:

Why do packagers, labelers, and holding companies have to have Master Batch Records and Batch Production Records from the manufacturer?
The FDA requires that packaging, labeling, and holding companies be able to prove that the products they are labeling, packaging, or holding were manufactured in accordance with the FDA regulations. The regulations do
Not specifically what records are needed, but being the last to touch the product before the customer, it is their responsibility to gather and have readily available all data such as COAs, specs and testing results, MPR recipe, and batch manufacturing signatures in case of a recall or audit.

Why is the material with quality signatures for specifications not showing up in the selected list for project definition or Master Production Record bill of materials list?
Check that the material is in the list on View material specifications. If a Quality signature was received and the PM signature was not, that spec is locked in limbo. The system will not provide a link for you to create version 2 because it thinks version 1 is still being worked on. It will not allow the material to be used because it sees the PM signature is missing.

Why can’t I make a Batch Record from the Master Record?
Make sure all the required approval signatures for that Master Record have been confirmed, and try again. The Master record should now be a drop-down choice to make Batch records from.

How do I delete a record?
Once information is entered into InstantGMP MES, it cannot be deleted. It was designed this way to be in compliance with FDA requirements for electronic documentation (21 CFR part 11) and with the best practices of cGMPs.

If you have any other questions about InstantGMP software, please contact us or visit our recently expanded FAQ.

 

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