Electronic Signature & Workflow Approval

As regulatory bodies require more ability to trace process changes and ensure compliance with current regulations, manufacturers need assurance that the process has not been altered without approval.

MDT AutoSave is the only Automation Change Management system that has been 3rd party validated for compliance with FDA 21CFR11.

pharmaceutical industry. Line machine conveyer for packaging glass bottles ampoules in boxes at  factory
MDT AutoSave supports electronic signature and workflow approval for customers requiring an extra level of review/approval/audit of change.   The ability to manage these tasks electronically greatly streamlines the review process.  Features include:
  • Electronic Signature approvals (21CFR11 compliant)
  • Multiple review statuses
  • Verification and confirmation processes
  • Additional Security Features: password control, electronic log messages, configurable approval messages and more
  • Electronic Signature and audit trail support for documents
Flexible Approval Groups
Approval groups are set up based on the customer’s unique requirements.
Reviewers Can See Approval Details
Throughout the approval of a change, reviewers can see the status and comments by other reviewers.
Step-by-Step User Approval

Each user in the approval chain is notified and logs into AutoSave to review/approve the proposed changes. Approval status is managed throughout the process.