Regulatory

FDA 21 CFR Part 11 Compliance and Checklist

Compliance with U.S. Food and Drug Administration (FDA) 21 CFR Part 11 is essential for regulated companies using electronic records and signatures.

With 21 CFR Part 11, the FDA ushered in the use of modernised technology for records and submissions. The regulation made electronic records and signatures as valid as paper records and handwritten signatures. Part 11 does not mandate the use of electronic systems. Rather, it specifies the requirements for companies that choose to use digitised systems in their compliance efforts.

Free Resources

21 CFR Part 11: 7 Ways to Avoid Noncompliance

21 CFR Part 11 Videos

See how companies in many industries are able to easily comply with 21 CFR Part 11 using MasterControl.

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Free Resources on 21 CFR Part 11 Compliance.

Compliance with 21 CFR Part 11 is easier and more effective with connected quality systems.

Free Templates: 21 cfr part 11 compliance checklist template
White Paper: Validating Software Systems to Comply with CGMP and 21 CFR Part 11 Regulations
Industry Brief: 21 CFR Part 11: 7 Ways to Avoid Noncompliance

What Is 21 CFR Part 11?

21 CFR Part 11 states that electronic records and electronic signatures are treated the same as paper records and handwritten signatures. Regulated companies with any documents or records in electronic format must comply with the regulation.

FDA 21 CFR Part 11 Compliance Requirements

Gain a competitive edge with the MasterControl Quality Excellence solution. Automate and integrate all quality processes. Comply with 21 CFR Part 11 requirements faster and get to market sooner.

MasterControl Documents:

Complies with subparts A, B and C, section 11.3 by providing time-stamped audit trail, reporting, and electronic signature capabilities. Security features include dual passwords for document approval. It also has password expiration, encryption, and certification. An account lockout prevents unauthorised users from gaining system access.
MasterControl Validation Excellence Tool (VxT):

Complies with subpart B, section 11.10 by providing a risk-based approach to testing and software adoption. It drastically cuts down on the testing time and eases the overall validation burden, allowing companies to perform a complete validation in a matter of days, or even hours.
MasterControl Change Control:

Complies with subpart B, section 11.10 by automating every step of change control processes, enabing you to achieve faster turnaround times. Customisable reports show real-time status of change control tasks and the entire quality system.
MasterControl Training:

Complies with subpart B, section 11.10 by automating the management of all training processes. Easily route, follow up on and escalate training. Provide online exams, allow group sign off, and automate sequencing of training tasks.

How Can MasterControl Help With FDA 21 CFR Part 11 Compliance?

Many of the MasterControl solutions have been designed specifically to meet the requirements of 21 CFR Part 11. They help you ensure data integrity as well as maintain complete and accurate records that are accessible in real time.

Confidently comply with 21 CFR Part 11.

Master the regulatory pathways by automating record and signature processes.

MasterControl Product

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FDA 21 CFR Part 11 Compliance and Checklist

21 CFR Part 11 Videos

Free Resources on 21 CFR Part 11 Compliance.

What Is 21 CFR Part 11?

FDA 21 CFR Part 11 Compliance Requirements

MasterControl Documents:

MasterControl Validation Excellence Tool (VxT):

MasterControl Change Control:

MasterControl Training:

How Can MasterControl Help With FDA 21 CFR Part 11 Compliance?

Confidently comply with 21 CFR Part 11.

Quality Management Systems (QMS)

Training Management Software

FDA 21 CFR Part 11

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FDA 21 CFR Part 11 Compliance and Checklist

21 CFR Part 11 Videos

Free Resources on 21 CFR Part 11 Compliance.

What Is 21 CFR Part 11?

FDA 21 CFR Part 11 Compliance Requirements

MasterControl Documents:

MasterControl Validation Excellence Tool (VxT):

MasterControl Change Control:

MasterControl Training:

How Can MasterControl Help With FDA 21 CFR Part 11 Compliance?

Simplify All Regulatory Processes

Achieving Compliance With FDA Predicate Rules

Confidently comply with 21 CFR Part 11.

Quality Management Systems (QMS)

Training Management Software

FDA 21 CFR Part 11

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