0 Replies Latest reply on Oct 20, 2010 5:51 PM by Vijay Pisipaty

    Part 11 Compliant Digital Signatures for SAP SolMan-ChaRM

    Vijay Pisipaty

      It is typical for Pharmaceutical  Companies to have Part 11 Compliance extended to Change Control Systems  too, especially if the Scope Change impacts a GxP relevant process.

       

      SAP  Solution Manager's Change Request Management (ChaRM) functionality is  ITIL Compliant and has robust functionalities to support a comprehensive  Change Control Process together with decent workflow features and  abilities to integrate tranpsort logistics of SAP Systems.

       

      However, while Digital Signatures feature does exist for documents approval in SAP Solution Manager (SolMan), the Part 11 Compliant Digital Signatures feature is not delivered out of the box for ChaRM related Approvals and Status Changes for the following Transaction Types:

      • Change Request
      • Urgent Correction
      • Normal Correction
      • Administration Correction

       

      Pharmaceutical  Companies sometimes end up not using/implementing SolMan ChaRM because  of the lack of Part 11 Compliant Digital Signatures functionalities for  ChaRM.

       

      Through  Creative Configurations, the above mentioned pain point can very easily  be alleviated by introducing the functionality for "Part 11 Compliant  Digital Signatures feature for ChaRM related Approvals and Status  Changes" .

       

      To  know more about "Part 11 Compliant Digital Signatures feature for ChaRM  related Approvals and Status Changes" please see attached Solution  Brief and should you wish to know more, kindly send us an e-mail and we  can chat.