Automated 21 CFR Part 11 Regulatory Compliance Reporting

Read the “Hows-and-Whys” of
21 CFR Part 11
Compliance Reporting

“Changes constantly happen and we need to provide audit-ready reports that prove we're in compliance. Ecora Auditor Professional's reporting capabilities allow us to automatically manage congigurations and changes throughout our infrastructure.”

— Director of Technical Operations
SISU Medical Systems

21 CFR Part 11 Reports in a Box with Auditor Pro!

Auditor Professional gives you the answers to the most critical 21 CFR related questions such as:

  • Who has access to systems holding financial records?
  • Who has access to Share information?
  • Where are internal security vulnerabilities?
  • What patch levels are we at?
  • Are configuration changes being tracked and documented?
  • What policies are changing within Active Directory?
  • Can we show an audit trail?
  • And much more…

Let's face it. You need to provide an audit trail showing you have control over your infrastructure. You also need to have documented evidence that provides assurance a specific system is configured to operate in accordance with predetermined requirements and specifications as set forth in 21 CFR Part 11.

Over 500 companies use Ecora Auditor Professional to generate reports for the IT Audit portion of the 21 CFR Part 11 compliance process. The most popular reports found within Auditor Pro that are required as part of the 21 CFR Part 11 IT Audit process include:

  • Password Aging
  • Consolidated Change Logs
  • User Privileges
  • NTFS Permissions
  • System Privileges
  • Role Permissions & Membership
  • Remote Access
  • User Access
  • Auditing Enabled


Ecora's solutions provide hundreds of audit-ready report templates and a policy-based dashboard for effective 21 CFR Part 11 Compliance.

More Information

To find out how Ecora can help with your regulatory compliance and IT best practice initiatives by automating detailed configuration and change reporting within your IT infrastructure – call 877.92.ECORA, or 603.436.1616, or e-mail sales@ecora.com.

Reports for 21 CFR Part 11 compliance: