Understanding CFR21 Part 11 Compliance in Chromperfect

What is CFR21 Part 11?

CFR21 Part 11 is a section of the U.S. Food and Drug Administration (FDA) regulations that sets out the criteria for electronic records and electronic signatures to be considered trustworthy, reliable, and equivalent to paper records. It applies to any FDA-regulated organization that uses electronic systems to create, modify, store, or transmit regulated data.

Why is it important?

For laboratories, compliance with CFR21 Part 11 is critical for meeting regulatory requirements, passing audits, and ensuring data integrity. Without compliance, organizations risk failed inspections, product delays, and even legal penalties. It’s not just about following rules — it’s about protecting the accuracy, security, and authenticity of scientific data.

Key requirements include:

• Secure user authentication — ensuring only authorized personnel can access the system.

• Audit trails — tracking all changes to records with date, time, and user details.

• Data integrity — preventing tampering or unauthorized modification.

• Electronic signatures — ensuring signatures are unique, secure, and linked to the corresponding record.

  
  

How Chromperfect ensures compliance

Chromperfect Version 10 includes full built-in CFR21 Part 11 compliance capabilities. This eliminates the need for unsecured file storage or manual workarounds. Key features include:

• Secure database storage for all chromatographic data.

• Automatic audit trails for every action, recorded with user, date, and time.

• Role-based access control to ensure only authorized users can perform specific functions.

• Integrated electronic signature system that complies with FDA standards.

• One-way communication control to ensure data cannot be altered at the instrument level after acquisition.

  
  

The result?

Labs using Chromperfect can be confident their electronic records and signatures meet regulatory standards, reducing audit stress and ensuring data integrity from acquisition to long-term storage.

If your lab needs CFR21 Part 11 compliance,

Chromperfect provides a proven, secure, and fully compliant CDS platform — helping you stay audit-ready at all times.