Life Sciences

21 CFR Part 11 Decoded: Signature Manifestations

fda-electronic-signatures

 

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. 

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11.50 – Signature Manifestations

Deployed on-premisesIntegration/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

NoN/A
Skype for Business Server or Lync Server on-premises

Exchange Server

YesThis article
Exchange Server on-premises

Skype for Business Online

YesFollow the guidance in the Exchange blog series.


Cloud Connector Edition (CCE)

Skype for Business Online

NoNo. (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.

If you have questions between now and the next post, feel free to contact us. To read past posts in the 21 CFR Part 11 Decoded series, click here.

And by the way, up there? That is someone’s real signature – a man by the name of Kurt Vonnegut, Jr. 🙂

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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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