Compliance 21 CFR Regulations 21 CFR Part 11


FDA 21 CFR Part 11 Compliance

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 modernized 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 digitized systems in their compliance efforts.

21 CFR Part 11 Industry Overview: Ready for an FDA Inspection?

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 unauthorized 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. Customizable 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 and escalate training. Provide online exams, allow group sign off and automate sequencing of training tasks.


Simplify All Regulatory Processes

21 CFR Part 11 simplifies records management and signature processes by permitting the use of digital technology for these quality tasks. FDA-regulated companies will naturally benefit from more speed and better efficiency, which can be achieved with the right quality management system (QMS).


Achieving Compliance With FDA Predicate Rules

21 CFR Part 11 applies to predicate rules such as the current good manufacturing practice (CGMP), good laboratory practice (GLP) and good clinical practice (GCP) regulations. Another rule is that companies must retain certain records for a specific amount of time. Access to documents must be available upon request. A paperless record management system makes it easier to comply with this rule.

Free Resources on 21 CFR Part 11 Compliance.

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

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.

Download Your Free 21 CFR Part 11 White Paper
[ { "key": "fid#1", "value": ["Everything else"] } ]