Regulatory compliance tool: Electronic approval and audit trails for automation devices
MDT Software, a provider of change control solutions for automated manufacturing assets, has introduced the AutoSave Approval and Audit Trail Modules to support electronic approval with detailed audit trails for automated device programs and documents. MDT’s AutoSave is an enterprise source management solution to secure, protect, save, restore, discover, and track changes in PLCs, HMIs, SCADA systems, robots and other industrial programmable devices and documents.
MDT AutoSave is designed to be used as part of the change control and audit infrastructure that ensures manufacturers that processes have not been altered without approval or documentation. AutoSave’s change control features, including internal security capabilities, have been used in regulated industry sites to meet the requirements of the FDA, including compliance with 21 CFR 11. The AutoSave Approval and Audit Modules were developed to augment AutoSave’s existing device program and document modules with the following advanced workflow and approval functionality:
- Electronic approvals: Approval groups can be configured via drag-and-drop interface allowing users to be assigned to one or many devices or documents; automatic capture of audit trail information including the approver’s user ID and comments, activity date and time stamp; complete revision history and in-process status of active development projects available on-demand.
- Multiple review statuses: View program versions that are in different statuses (request for approval, test, validate, implemented); complete history of review and approvals.
- Verification & confirmation processes: Access to key processes requires users to re-enter their password, thereby verifying active user status; automatic email to approvers prompts the need for review and approval of a device program or document change; user privileges are verified automatically prior to confirmation.
- Additional security features: Control of expiring password and prior password re-use; email addresses for AutoSave users captured for approval and other notifications; existing automatic logs augments with additional, electronic log messages; configurable required approval processes.
MDT’s AutoSave Reports Module, which is included with the AutoSave Approval & Audit Trail Modules, allows users to generate more than 70 unique reports from the historical data stored in AutoSave. Users can filter data to specific information such as client, agent or user, create specialized audit reports and view program statistics.
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