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

In 2007, the FDA set forth rules governing e-signatures 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 your 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 products they are labeling, packaging or holding were
manufactured in accordance with the FDA regulations. The regulations do
not say 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, 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 for visit our recently expanded FAQ.

 

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