Long-Term Tracking of Your Corrective Action Plan

Part 11 Advisor facilitates the long-term tracking of Corrective Action Plans. Part 11 Advisor:

• Tracks the completion of your short and long-term corrective actions.
• Builds corporate policies for how electronic records and signatures will be controlled.
• Creates short-term gains of 10–25% simply by educating your workforce about Part 11 requirements.

Summary Report

Part 11 Advisor creates summary reports for each system, which include system descriptions and the current state of Part 11 compliance.

System Evaluation Results Report

The Part 11 Advisor produces detailed System Evaluation Results reports, demonstrating how your system does or does not comply with each aspect of 21 CFR Part 11.

Corrective Actions Report

The Part 11 Advisor creates a Corrective Action Report which lists all the corrective actions (both approved and unapproved) for each system, and provides a summary of the time and cost estimates. This report can also be run for all systems so that you can get a good idea of the total time and cost for the entire remediation program.

Additional Information

Part 11 Advisor – Assess your compliance with 21 CFR 11.

• Part 11 Advisor Main Screen
• Evaluation and Review
  • Gap Analysis screen
  • Corrective Action Wizard
• Long Term Tracking of Part 11 Assessment Corrective Actions
  • Corrective Action Reports
  • Summary Reports