Everything You Need to Know About 21 CFR Part 11

Data integrity is crucial to establishing and maintaining the trust of regulators. For companies under scrutiny, if you want to maintain market access, you must be 21 CFR Part 11 compliant.

How well do you understand your regulatory requirements? In this short fact sheet, you’ll get everything you need to know about the regulation synonymous with data integrity.

You Will Learn:

  • Key facts about the regulation
  • How to comply with your requirements
  • How Kneat Gx enhances data integrity and keeps you compliant

Why Kneat

Proven

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Industry-Leading Validation

Kneat is trusted by 8/10 world’s largest life sciences companies to provide digital validation and GDP solutions across the entire manufacturing lifecycle.

Data Integrity

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Uncompromised Data Protection

We protect data integrity across the entire validation lifecycle with password protected signatures, automatic timestamps, and a comprehensive audit trail.

Efficiency

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Maximized Process Efficiency

Kneat is Proven to reduce validation cycle times by 50% across multiple validation disciplines through online test execution, remote approval, and more.

Trusted

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Seamless Audit Preparation

We set you up for audit success from the start with automatic audit trails and easy paperless handovers  to make it easier for audits and remote inspectors.

Contact

Talk to us

Find out how Kneat can make your validation easier, faster, and smarter.
Start your paperless validation revolution by speaking to our experts.

Europe: +353-61-203826
U.S: +1 888 88 KNEAT
Canada: +1 902 706 9074