It is typical for Life Sciences, Pharmaceutical, Food and Beverage Companies (i.e. FDA and GxP Standards regulated industry segments) to have Part 11 Compliance extended to Change Control Systems too, especially if the Scope Change impacts a GxP relevant process.
SAP Solution Manager' 7.1 Change Request Management (ChaRM) functionality is ITIL Compliant and has robust functionality to support a comprehensive Change Control Process together with decent workflow features and abilities to integrate transport logistics of SAP Systems.
However, as you all maybe aware, while ABAP GUI based Digital Signatures feature does exist for documents approval in SAP Solution Manager (SolMan), the "Digital Signatures functionality in SolMan 7.1 & CRM 7.0 Web UI for ChaRM Approvals" is NOT delivered out of the box for the following CRM Service Process Transaction Types:
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 in SolMan 7.1 & CRM 7.0 Web UI for ChaRM Approvals" please see attached Solution Brief and should you wish to know more, kindly send us an e-mail and we can chat.
Enjoy SAP Solution Manager 7.1 !!!!
IT Sapiens, Inc.