This is the third post in the 21 CFR Part 11 “mini-series” focused on Subpart B – Electronic Records. This time, we’re decoding Section 11.50 – Signature Manifestations. Do you have your rings ready?
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.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
11.50 – Signature Manifestations
|Deployed on-premises||Integration/Hybrid with||Preparation Required||Guidance
|Skype for Business Server or Lync Server on-premises||Skype for Business Online||Yes||This article|
|Skype for Business Server or Lync Server on-premises||Federation with other customers or partners in Office 365 (current or future)||Yes||This article|
|Skype for Business Server or Lync Server on-premises||No||N/A|
|Skype for Business Server or Lync Server on-premises||Exchange Server||Yes||This article|
|Exchange Server on-premises||Skype for Business Online||Yes||Follow the guidance in the Exchange blog series.
|Cloud Connector Edition (CCE)||Skype for Business Online||No||No. (ensure you do not federate with customers in Office 365 or integrate with PIC as describe in the first scenario)
|Skype for Business Server or Lync Server on-premises||Skype for Business Online||No. (ensure you do not federate with customers in Office 365 or integrate with PIC as describe in the first scenario)||N/A|
11.50 is pretty straightforward – not much work for those decoder rings, this time. But, there is an entire Subpart on Electronic Signatures, so 11.50 is just the beginning.
Up next is the final episode in the Subpart B mini-series: Section 11.70 – Signature/Record Linking.
And by the way, up there? That is someone’s real signature – a man by the name of Kurt Vonnegut, Jr. 🙂