Quick Guide to 21 CFR Part 11

All you need to know about 21 CFR Part 11

It’s easy to be overwhelmed by long, complicated U.S. Food and Drug Administration (FDA) regulatory requirements. This quick guide provides an overview of the fundamentals you need to know to meet 21 CFR Part 11 guidelines and explains how modern digital tools can help you do it more efficiently and effectively. This guide outlines: 

  • The key elements and criteria of 21 CFR Part 11 compliance.
  • How proven digital quality and manufacturing tools facilitate compliance with 21 CFR Part 11 guidelines.
  • The purpose of 21 CFR Part 11 and the benefits of streamlined compliance.

Simplify 21 CFR Part 11 Compliance With MasterControl

Simplify 21 CFR Part 11 Compliance With MasterControlWith MasterControl quality management system (QMS) and manufacturing execution system (MES) software, you never have to sacrifice compliance to achieve efficiency. Our solutions are designed to ensure compliance with regulatory requirements, while also increasing operational efficiency. By natively connecting quality and manufacturing data in one powerful digital tool, MasterControl enhances data connectivity and provides real-time visibility into processes across the entire life cycle of your regulated products. Read on to learn how to add efficiencies, embed quality into manufacturing operations, and bring your life-changing products to market faster.

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21 CFR Part 11 Compliance FAQ

Why is FDA 21 CFR Part 11 important for life science manufacturers?

21 CFR Part 11 guidelines were established to help manufacturers in the life sciences ensure the authenticity, integrity, and reliability of electronic records and signatures. They enable quality and manufacturing professionals to work more efficiently in regulated environments by using digital solutions.

How can we ensure compliance with FDA 21 CFR Part 11 when using electronic systems and records in manufacturing processes?

The surest way to meet 21 CFR Part 11 guidelines is to use reliable, purpose-built software. A proven digital solution will maintain audit-ready, e-signed records in a central repository and authenticate users. 

What are the validation requirements for electronic systems under FDA 21 CFR Part 11?

Any electronic system used for regulated activities must be validated to show that it performs as intended and meets 21 CFR Part 11 compliance requirements. Trusted providers offer innovative tools that accelerate validation time.

How can digital quality management systems assist us in achieving and maintaining compliance with FDA 21 CFR Part 11?

Software designed to facilitate 21 CFR Part 11 compliance unifies the goals and collaborative efforts of quality and manufacturing teams. With modern tools optimizing regulatory activities, compliance can be transformed from an obligation into an accelerator. 

Key 21 CFR Part 11 Requirements

Staying ahead of the compliance curve requires an understanding of 21 CFR Part 11 guidelines. The following are some of the basic elements of 21 CFR Part 11 for which criteria have been established.

  • Electronic Records

    FDA 21 CFR Part 11 defines what electronic records are and establishes requirements for how to create, maintain, and archive them. It emphasises the need to ensure that electronic records are accurate, legible, and retrievable throughout their retention period.

  • Electronic Signatures

    “E-signatures” authenticate electronic records, and 21 CFR Part 11 compliance requires them to be unique to the individual, securely managed, and linked to corresponding records. Their criteria are outlined in FDA 21 CFR Part 11.

  • Electronic Audit Trails

    Audit trails track changes made to electronic records, allowing for a thorough view of a record's history, including when and by whom changes were made. 21 CFR Part 11 compliance calls for companies to implement secure, computer-generated audit trails. 

  • User Authentication and Authorisation

    21 CFR Part 11 requires companies to establish procedures to ensure that only authorised individuals can access electronic records and create, modify, or approve them. 

Unlock the secrets to 21 CFR Part 11 compliance

Everything you need to know about 21 CFR Part 11 in one handy quick guide.

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Optimise 21 CFR Part 11 Compliance With Digital Tools

Since 21 CFR Part 11 makes electronic records equivalent to paper records, it’s critical to have document and process management software that’s specifically designed for compliance. Below are just a few examples of ways advanced tools are making 21 CFR Part 11 compliance easier for today’s quality and manufacturing professionals.

  • Inspection-Ready Electronic Records

    A purpose-built digital solution empowers quality and manufacturing departments with complete, compliant, and readily accessible documentation. A proven solution built for 21 CFR Part 11 compliance protects all records in a secure document repository only accessible by authorised users. 

  • Reliable Electronic Signatures

    A robust software solution provides fields for all information required for FDA 21 CFR Part 11-compliant signatures, including name, date/time of signing, and meaning of the signature. 

  • Automated Audit Trail Capture

    21 CFR Part 11 requires users of electronic records to have a system in place to capture secure, computer-generated, and time-stamped audit trails that record the date and time of entries and actions involved in creating, modifying, or deleting records. Modern digital solutions automatically capture and maintain this data and export it in human-readable format.

  • Comprehensive User Authentication and Authorisation Enforcement

    A proven 21 CFR Part 11 compliance software solution like MasterControl offers multiple levels of security to ensure the authenticity of each user, document, and electronic signature in the system. 

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