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Life Sciences

21 CFR Part 11 Decoded: Controls For ID Codes/Passwords



Welcome to the final post in the 21 CFR Part 11 “mini-series” on Subpart C – Electronic Signatures, which happens to be the final section in the 21 CFR Part 11 regulation. Let’s polish up our decoder rings one last time for Section 11.300 – Controls for Identification Codes/Passwords.

In the table below, the actual language from each regulation is on the left, and my personal interpretation of what that language means is on the right. Keep in mind that I do not represent the FDA and nothing in the “Interpretation” column should be taken as fact. 

11.300 – Controls for Identification Codes/Passwords

Issue TitleBehavior / SymptomKnown WorkaroundDiscovery Date
AutoStart on Linux is not working.AutoStart on Linux does not start the Teams application.
White screen when resuming from sleep/suspend.
When your computer resumes / wakes from sleep or suspend mode there can be a network change (especially when the computer is connected to VPN before put to sleep/suspended) and that takes some time for the computer to reobtain the connection. The combination of these things can lead to a Teams white screen.
Restarting Teams client will help.
Cursor missing when screen sharing.
While sharing screen, the other party does not see the cursor of the person sharing the screen.
Issue running in parallel with VMWare workstation.
The Teams application experiences issues when running in parallel with VMWare workstation.
KDE notifications create new taskbar.
Notification on KDE creates new window in taskbar.
Package managers not showing changelist.
Package manager does not show changelist.
Cannot launch Teams client in offline mode.
Unable to launch Teams Offline in Linux client.
Device settings while in meeting.
When in a meeting and changing device settings, the Microphone indicator isn't registering anything being picked up.
Can't close Teams application using keyboard.
Can't close the Teams application using the default $mod + shift + q or by clicking the close button in the app.

And, that’s it! You’ve made it all the way through 21 CFR Part 11! I hope you feel like you have a better understanding of what this set of regulations is about and why it’s important in the life sciences industry.

In the next and final post in this 21 CFR Part 11 Decoded series, I’m going to attempt to summarize everything we’ve covered. Check back soon!

If you have questions between now and the next post, feel free to contact us.

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Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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