Monday Oct 20, 2008

FDA 21 CFR Part 11 Compliance: Dual Identification for Signoffs

Here's an extract from the Federal Register that lays out the final ruling of 21 CFR Part 11: "Section 11.200 provides that electronic signatures not based on biometrics must employ at least two distinct identification components such as an identification code and password". With Agile 9.2.2.2, we've provided an ability for Administrators to configure specific workflow statuses that require signoff to require an additional form of user authentication along with the usual approval password. The Administrator also has the flexibility of determining what the second form of user authentication should be. [Read More]

Monday Sep 22, 2008

Storing outbound compliance information in PGC

You obviously know that you can use a Declaration to gather compliance information from your suppliers. Those are inbound Declarations where the data is submitted by Suppliers or content providers. But, did you know you can also use a Declaration for storing "outbound" compliance to be shared with your Customers? In PLM's 9.2.2.4 release, you can make use of the attribute Exclude from Compliance Check in Declaration-Items or Declaration-Mfr Parts or Declaration-Part Groups tabs. This is a list field with values of "Yes" and "No" and the purpose of this field is to use for "outbound" Declarations. Note that this is different from the Exclude from Rollup flag in the cover page of an Item. The Exclude from Rollup field flags the entire Item to be excluded from compliance rollup, while the Exclude from Compliance Check flags just that particular Declaration/Composition to be excluded from compliance rollup. Here are the steps you can follow to create an "outbound" Declaration:[Read More]
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