New framework: 21 CFR Part 11 now available in Scrut

What's new?

Scrut now supports 21 CFR Part 11 compliance within the Frameworks module, giving you a structured, centralized way to manage electronic records and signature validation requirements set by the FDA. Compliance is critical for organizations operating in life sciences, including pharmaceuticals, medical devices, and biotechnology.

Why was this needed?

Meeting 21 CFR Part 11 requirements is essential for FDA-regulated industries to ensure product quality and safety. Non-compliance can result in warning letters, regulatory observations, and delays in product approvals. Scrut's framework provides you with the tools to standardize your validation strategy, streamline audit readiness, and demonstrate compliance to regulators and stakeholders.

How it works

• Access the 21 CFR Part 11 framework from the Frameworks module.

• Assign control owners, track implementation status, and monitor compliance progress using automated workflows.

• Connect requirements to your policies, risk management processes, and technical documentation in one centralized location.

• Create detailed readiness reports to demonstrate compliance to stakeholders.

Need help?

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