Electronic Signature and part 11 complaince

admin June 3rd, 2018 Posted by Orcanos Team( )

Dynamic start routing – when the user starts routing, the user can change the flow on the fly! both for DMS items and other electronic records

For more information – click here

Electronic Signature and part 11 complaince

Add Quality role (Approver/Reviewer) to the cover letter

 

Include more detail on email notification when reject/cancel routing process (such as who rejected, item key, and date)

 

Ability to manage signers info in the work item form, both for electronic records and DMS items (available when item is in routing:

  • Next Assignee List – show list of users that need to sign next
  • Signers list – shows the list of all users that participate in current esign
  • Singers details – for each next signer – indicate whether its a user, group, or alternate signer

Signer Details

 

Multi e-sign – Ability to e-sign multiple work items at once from Work Items

Multi e-sign

 

Add the “Reject reason” to the audit log


About the author, Orcanos Team

Orcanos software was founded on 2005 by Zohar Peretz and Rami Azulay. Orcanos is the only company that provides an integrated software for ALM (Design Control) and Quality management (QMS), combined with regulations compliance, specializes in the medical device industry. 

Orcanos

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info@orcanos.com

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