Insuring Quality and Compliance

As regulatory bodies require more ability to trace process changes and ensure compliance with current Good Manufacturing Practices (GMP), manufacturers are seeking ways to be assured the process has not been altered without approval.

Our software is part of the change management and audit infrastructure that ensures this compliance. We track 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, our software periodically queries your automation devices and compares the code running in the processor with what we have on file. If a mismatch is detected (indicating someone went around our system to make a change), we send notification to key personnel highlighting the mismatch along with information pinpointing the changes.

To further increase the level of change control, our latest version of AutoSave provides workflow approval routing and electronic signature functionality in support of 21 CFR 11 guidelines.

Support for Pharmaceutical Change Management

MDT Software has enhanced AutoSave to support the move to electronic approval processes in highly regulated environments. Now, workflows and approvals can be managed electronically, greatly streamlining the review process. Features include:

• Approval Processing of Changes
• Verification of User Passwords before Critical Operations
• Logging of all administration changes
• Reporting

This Regulated Industries feature set can be enabled on devices requiring a formal change process, allowing user-defined groups for review and approval. As a change progresses through the review process its status is updated to indicate who has reviewed the change. Only approved changes can be downloaded for testing, and only after validation can it be “implemented.” All activities are logged, and reports can be generated on-demand to show activity and status of changes.

We serve the pharmaceutical market through our distribution and integration network.