Challenges in practice
Consistent conformity is particularly important in the sensitive processes in the medical technology / pharmaceutical and chemistry / food industries. Various standards and guidelines require continuous controls, complete and tamper-proof documentation and comprehensive risk management. Standard authentication mechanisms are often no longer sufficient for the processes of your QA/QM system. Electronic signatures are also required for the release of critical process sequences or product releases by the qualified person for medical devices.
Solution QS1
In addition to the LDAP connection to your Active Directory for authentication in QS1, our solution offers you the option of processing and releasing risky processes and data with an electronic signature. Based on the QS1 authorisation role concept, you can identify those areas for your company where an electronic signature is necessary and useful. Whether in workflow-controlled document management, the final assessment of a CAPA process or the release of your end product batches by the Qualified Person, you can use the electronic signature in many areas of QS1 up to the ‘4/6 eyes’ principle.
