21 CFR Part 11 Compliance: 7 Must-Have System Features for Medical Device Manufacturers

It’s easy for medical device manufacturers to get confused about what the U.S. Food and Drug Administration (FDA) expects of them in terms of creating and maintaining electronic records and their associated electronic signatures. In fact, the requirements for electronic records and signatures outlined in FDA 21 CFR Part 11 can so overwhelm some companies that they stick to familiar paper-based systems and shun digital quality management tools that could dramatically enhance efficiency and simplify their compliance activities.

If your organization is considering implementing or upgrading an electronic record/signature management solution, know that there are seven facets the system must effectively manage to uphold 21 CFR Part 11 compliance. Although the following is not a comprehensive list of specific 21 CFR Part 11 compliance requirements, you’ve taken the biggest step toward meeting the FDA’s expectations if your new system addresses each aspect.

21 CFR Part 11 – Medical Device Manufacturers’ Systems Checklist

#1. Authentic Electronic Records

21 CFR Part 11 compliance is contingent on the assurance of electronic records’ authenticity. The onus of authenticity falls on the electronic quality management system a company chooses to use, and its administrators. Administrators must designate user permissions for every document vault the system contains. The system must also be capable of generating an audit trail for every record captured. Audit trails help ensure the ongoing accuracy, completeness, integrity, and security of the electronic records.

#2. Unique Electronic Signatures

Each individual user must be assigned a personalized digital signature. To meet 21 CFR Part 11 compliance requirements, all signed electronic records must include the following:

• Name of the signer.
• Date and time the document was signed.
• Meaning/type of the signature (i.e., approval, author, review, etc.).

The system should provide fields for all such information. A robust digital quality management system also typically offers configurability for including additional fields for supplementary data that may be needed for specific business purposes.

#3. Record and Signature Interconnectivity.

To ensure that signed electronic records are ready for auditor review during an FDA 21 CFR Part 11-related inspection, there must be traceability from each record back to its signers. This also applies to handwritten signatures on paper documents that are scanned into the system.

#4. Identification and Password Authentication

It’s mandatory to minimize the potential for a signer to repudiate an approval. To meet 21 CFR Part 11 compliance requirements in this regard, the system must employ at least two distinct identification components: a unique identification code and a password. If a series of signings are required, the first signing must include all ID components. Subsequent signings must include at least one of the user’s unique electronic signature components. Security-focused software solutions tend to require separate passwords for system login and signoff.   

#5. Training Integration.

FDA 21 CFR Part 11 states that anyone who develops, maintains, or uses electronic systems for records/signatures must be trained to perform their assigned tasks. Modern quality management systems with integrated employee training capabilities automatically trigger new training courses whenever documents are revised, thereby maintaining continual organizational compliance. A robust solution should also be able to create audit trails for all training-related information, maintain employee training records, and automate follow-up and escalation of past-due training tasks.

#6. Effective Change Control Management.

To stay compliant, you must maintain an audit trail that traces the time-sequenced development and modification of system documentation. This requires appropriate revision and change control procedures. While a proven solution can do much of the heavy lifting required for effective change control, this aspect of 21 CFR Part 11 compliance requires a thorough evaluation of your business processes and protocols to see how they match up with the requirements.

#7. System Validation.

FDA predicate rules mandate that any electronic system used to manage compliance-related documents and processes must be validated. Historically, validating a system in accordance with FDA 21 CFR Part 11 requirements has been a costly and time-consuming effort. But an advanced solution with a track record of rapid validation performance can drastically reduce the overall burden. MasterControl’s patented (U.S. Patent 10,324,830 and 10,664,380) VxT validation accelerator provides a fast, cloud-based validation experience that is not offered by anyone else in the industry. On average, customers using VxT have reduced 104 hours of labor-intensive validation work to just 20 hours. Plus, they’ve cut an average of 336 hours of overall project preparation time.

Ensure 21 CFR Part 11 Compliance With Purpose-Built Tools

The surest way for medical device manufacturers to maintain compliance with FDA 21 CFR Part 11 is to implement a proven solution that’s designed to meet the regulation’s requirements. A purpose-built digital system can take the pain and inefficiency out of managing documents and signatures. MasterControl quality management solutions are specifically engineered to help device manufacturers and similarly regulated companies align their compliance processes with regulatory expectations. When paired with our specialized medical device manufacturing software, MasterControl’s advanced quality tools help companies extend quality directly to the shop floor. Together, our quality and manufacturing solutions enable true inline quality, allowing organizations to predict and prevent quality issues in real time. Learn more about the combined power of modern, digitally integrated quality and manufacturing execution systems here.