Razorleaf Corporation » EPDM and FDA Compliance | Razorleaf Corporation

EPDM and FDA Compliance

Daniel Rohats — Tue, 09 Nov 2010 00:11:14 +0000

One of the common misconceptions about 21 CFR Part 11 (the body of law that governs medical device makers in the United States) is that there are software packages available that can make companies compliant with the law. Being compliant with these regulations requires that your process be compliant, and even the best software can’t really make you 21 CFR Part 11 compliant. However, software can certainly provide enablers and automation to allow for faster, more efficient, better integrated, and easy-to-use processes. SolidWorks EPDM has some functions and tools built-in to help companies conform to the FDA requirements.

One of the key requirements of 21 CFR Part 11 relates to electronic signatures. Electronic signatures require a double challenge, meaning that the user’s login to an electronic system is not sufficient evidence that they are providing their signature on a record – they need to be challenged a second time, at the moment when they are providing their signature. EPDM provides double challenge signatures through its Workflow tool. When creating a workflow transition, one of the options on the properties window is the check box for Authentication.

When the check box for Authentication is checked, users who attempt to pass documents through this transition will be required to enter their password in order to do so. The password box appears right on the transition dialog box in the lower right corner. If the challenge fails, the transition is not permitted. If successful, the transition continues as expected.

So, by requiring Authentication on specific EPDM workflow transitions, and by assigning specific meanings to those transitions, a 21 CFR Part 11 electronic signature can be obtained. You can see how this is a marriage of process and software capabilities. Some additional features of Enterprise PDM that can aid in regulatory compliance:

Showing specific user groups only the latest released revision of a document: This is done with the combination of Folder and Workflow permissions.
Full History tracking per document: Users can see the full history of a document through the right mouse click History menu command.
Users with the appropriate permissions can retrieve previous released revisions: This feature is also accomplished through workflow and folder permissions. Users can access the other revisions through the right mouse click Get Version menu command.

Other compliancy capabilities can be configured in Enterprise PDM, especially using workflow. For example, CAPA (Corrective And Preventative Action) processes, document approval, and other cGMPs (current Good Manufacturing Practices) can all be modeled using the configurability of Enterprise PDM. To learn more about how EPDM can help enable industrial or governmental regulatory compliance, please contact us.

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