0 Replies Latest reply on Oct 20, 2010 5:55 PM by Vijay Pisipaty

    Part 11 Compliant SolMan Documents eSignature with Workflow..

    Vijay Pisipaty

      It is typical for  Pharmaceutical/Life Sciences Companies that use SAP Solution Manager as a  document repository tool, to seek Part 11 Complaint Digital Signatures  for Documents and also have the approval routing be managed with  workflow.

       

      However, following is the Synopsis of Documents related Digital Signature functionality in SAP Solution Manager:

      • Digital Signatures are used in conjunction with Status Schema
      • After 1st signature execution Document gets locked for any further changes
      • There is no standard ability to execute subsequent signatures for the Document
      • There is no standard integrated workflow features to route the Document for review and approval
      • After 1st signature  execution, all subsequent approval/rejection related Digital Signatures  execution only possible by manually unlocking document and changing  status
      • The Digital Signature is NOT Part 11 compliant due to following:
        • User ID of Signatory is defaulted into the Signature
        • User ID defaulted into the Signature is not changeable
      • Document author does not get notified if Document has been rejected at any stage of approval


       

      Through Creative Configurations, the above mentioned deficiencies have been alleviated and there  now exists a creative solution (without any source code modification)  with the following features to overcome the gaps in standard delivered  Document Digital Signature functionality in Solution Manager, and the  solution has the following features:

       

      • Part 11 (2-part) Compliant Signatures
      • Integrated Workflow based Notifications
      • Configurable Rules for Approvers/Signatories Determination
      • Supplements Solution Manager Document Repository functionality with Document approval workflows
      • Scalable to Documents stored outside of Solution Manager too
      • Enhanced Logs for Audit Trail

       

       

      To know more, please see attached Solution Brief and should you wish to know more, kindly contact:

      Vijay Pisipaty

      IT Sapiens, Inc.

      vijay.pisipaty@itsapiens.com