This post is the second in the 21 CFR Part 11 “mini-series” that is focused on Subpart C – Electronic Signatures. Today, we’ll be using our decoder rings to learn the secrets in Section 11.200 – Electronic Signature Components and Controls.
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.
11.200 – Electronic Signature Components and Controls
| Mode | Microsoft Teams Admin Center | PowerShell (per user) |
|---|---|---|
| Islands | Available | Grant-CsTeamsUpgradePolicy -PolicyName Islands -Identity $SipAddress |
| Islands + Notify the Skype for Business User | Available | Grant-CsTeamsUpgradePolicy -PolicyName IslandsWithNotify -Identity $SipAddress |
| Skype for Business Only | Available (routing only currently) | Grant-CsTeamsUpgradePolicy -PolicyName SfBOnly -Identity $SipAddress |
| Skype for Business Only + Notify the Skype for Business User | Available (routing only currently) | Grant-CsTeamsUpgradePolicy -PolicyName SfBOnlyWithNotify -Identity $SipAddress |
| Teams Only | Available | Grant-CsTeamsUpgradePolicy -PolicyName UpgradeToTeams -Identity $SipAddress |
| Skype for Business with Teams Collaboration | Available | Grant-CsTeamsUpgradePolicy -PolicyName SfBWithTeamsCollab -Identity $SipAddress |
| Skype for Business with Teams Collaboration + Notify the Skype for Business User | Available | Grant-CsTeamsUpgradePolicy -PolicyName SfBWithTeamsCollabWithNotify -Identity $SipAddress |
| Skype for Business with Teams Collaboration and Meetings | Available | Grant-CsTeamsUpgradePolicy -PolicyName SfBWithTeamsCollabAndMeetings -Identity $SipAddress |
| Skype for Business with Teams Collaboration and Meetings + Notify the Skype for Business User | Available | Grant-CsTeamsUpgradePolicy -PolicyName SfBWithTeamsCollabAndMeetingsWithNotify -Identity $SipAddress |
Clearly, biometric signatures are less complicated to keep in compliance, but they are also rather pricey, so they are not that common. Non-biometric signatures are a little more complicated to configure for compliance, but they’re still manageable. If you’re interested in learning more about implementing non-biometric electronic signatures, click here.
The next post is the final episode in the Subpart C mini-series on Electronic Signatures AND the penultimate post in the 21 CFR Part 11 Decoded series. We are almost there!
If you have questions between now and the next post, feel free to contact us.
