Overview
21 CFR Part 11 facts
In this overview you will learn
- Key facts about the regulation
- How to meet your requirements
- How Kneat Gx keeps you complaint
Data Integrity
21 CFR Part 11 facts
Data integrity is crucial to maintaining the trust of regulators and keeping your products on the market. To stay in business, you must be FDA 21 CFR Part 11 compliant. This overview gives you a rundown of what you need to know and what you need to do to stay compliant.
Industry-leading validation
Kneat is trusted by 8/10 world’s largest life sciences companies to provide digital validation and GDP solutions across their entire manufacturing lifecycle.
Uncompromised data protection
We protect data integrity across the entire validation lifecycle with password protected signatures, automatic timestamps, and a comprehensive audit trail.
Maximize efficiency
Kneat is proven to reduce validation cycle times by 50% across multiple validation disciplines through online test execution, remote approval, and more.
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.