As regulatory bodies require more ability to trace process changes and ensure compliance with current regulations (i.e. 21CFR11), manufacturers are seeking ways to be assured the process has not been altered without approval.
Electronic Signature & Workflow Approval
- No other Automation Change Management system claims to be compliant with 21CFR11. MDT AutoSave is.
AutoSave tracks changes in PLCs, human-machine interface systems and workstations to ensure a proper audit trail and notification of changes. This can be invaluable in understanding what changes were made, why, and by whom.
In addition to providing rollback and recovery data in the event of device failures, AutoSave periodically queries your automation devices and compares the code running in the processor with the latest version stored on the AutoSave Server. If a mismatch is detected (indicating someone went around our system to make a change), a notification is sent to key personnel highlighting the mismatch along with information pinpointing the changes.
To further increase the level of change control, AutoSave provides workflow approval routing and electronic signature functionality in support of 21CFR11 guidelines. For areas requiring even greater electronic approval and audit trail support, AutoSave’s Add-On Modules provide this functionality.
- Electronic Approval & Audit Trails for Device Programs
- Electronic Approval & Audit Trails for Documents
MDT’s AutoSave Device Program Approval and Audit Trail Module provides the following support:
• Electronic Signature Approvals (21CFR11 compliant)
• Multiple Review Statuses
• Verification and Confirmation Processes
• Additional Security Features: specialized user group permissions, electronic log messages, configurable approval messages and more.
In order to provide comprehensive change control for plant-related documents, MDT offers the AutoSave Documents Module for the management of your plant procedures, drawings, and documents. The AutoSave Document Approval & Audit Trail Module augments the Documents Module with additional electronic approval and audit trail support.