GxP Lifeline
Checklist for Maintaining 21 CFR Part 11 Compliance
If your company operates under the oversight of the U.S. Food and Drug Administration (FDA), you know that 21 CFR Part 11 compliance is a big deal. It’s a critical regulatory requirement for pharmaceutical, biotech, and medtech organizations. Failure to comply with the regulation can result in serious consequences for life sciences companies, such as product recalls and legal actions. To avoid such consequences and ensure 21 CFR Part 11 compliance, you must first know the specific requirements the FDA has defined in the regulation.
Your 21 CFR Part 11 Compliance Checklist
The handy 21 CFR Part 11 compliance checklist below outlines the key aspects of the regulation that quality and manufacturing professionals in the life sciences should be aware of and continually working toward.
- Electronic Records:
- Electronic Signatures:
- Audit Trails:
- User Authentication and Authorization:
- Training:
- Validation:
- Data Integrity:
- Security:
- Record Retention and Retrieval:
The records maintained in computer systems must meet the criteria of being accurate, legible, and retrievable throughout their intended retention period. 21 CFR Part 11 compliance is contingent on establishing procedures for creating, maintaining, and archiving electronic records in a manner that ensures their integrity.
Serving as the digital equivalent of handwritten signatures, electronic signatures are used to authenticate electronic records. 21 CFR Part 11 compliance requires these signatures to be unique to the individual, securely managed, and linked to corresponding records.
Computer-generated audit trails track any changes made to electronic records, providing a comprehensive view of the record's history. Audit trails enable companies to identify when and by whom changes were made, contributing to the overall integrity of the record.
It’s essential to have processes in place to ensure that only authorized individuals have access to electronic records and can perform specific actions. Companies must establish procedures to confirm user identity and assign appropriate access levels based on job responsibilities.
Employee training and the effective management of training activities are also critical aspects of 21 CFR Part 11 compliance. Companies must provide comprehensive training to personnel who use electronic systems and maintain thorough electronic records of training activities. Training should cover regulatory requirements and proper procedures for ensuring compliance.
To demonstrate 21 CFR Part 11 compliance, companies must validate any computer system used for activities that are subject to regulatory oversight. Validation involves testing and documenting system functionality, security measures, and data integrity controls.
Since data is king in the life sciences, data integrity is a fundamental principle of 21 CFR Part 11 compliance. Companies must have controls in place to prevent unauthorized changes or deletions of electronic records. Adequate and appropriate controls are necessary to ensure that the accuracy, reliability, and unaltered state of electronic records and signatures is consistently maintained.
21 CFR Part 11 compliance depends on adequately protecting electronic records from unauthorized access, alteration, or destruction. Companies must implement both procedural safeguards, such as access controls, and technical safeguards, such as encryption, to ensure the security of electronic records.
Requirements specified in 21 CFR Part 11 mandate that electronic records must be available for inspection, review, and copying throughout their retention period. Systems must be in place that enable the retrieval and preservation of records as required.
Consequences of Noncompliance
Failure to meet 21 CFR Part 11 compliance requirements can result in harsh outcomes ranging from reputation damage to patient harm. To ensure 21 CFR Part 11 compliance and avoid catastrophes, companies need a robust system in place for managing both documents and processes. Today’s FDA compliance software solutions are designed to help life sciences companies avoid negative outcomes while easing the burdens typically associated with 21 CFR Part 11 compliance.
The Key to Simplifying 21 CFR Part 11 Compliance
A modern, purpose-built digital solution can offer a wide range of 21 CFR Part 11 compliance benefits. A proven solution from a reputable provider will empower companies with controlled, audit-ready records by ensuring complete, compliant, and readily available documentation. A good software solution will allow companies to automatically tick each box on the 21 CFR Part 11 compliance checklist. Specifically, a robust solution can ensure that:
- Electronic records are protected within a secure document repository accessible only to authorized users.
- Fields for all required signature information are provided and signatures are automatically linked to specified records.
- Secure and time-stamped audit trails are automatically recorded and exportable in a human-readable format.
- Multiple levels of security are established to ensure the authenticity of users, documents, and electronic signatures.
- Training and training records are comprehensively maintained, and the management of training tasks and records is automated. A purpose-built solution should also simplify the creation and deployment of training courses and create the requisite audit trails.
- Validation burdens can be alleviated via the use of advanced tools (such as MasterControl’s patented Validation Excellence Tool) that dramatically reduce the time and resources required for validation. A proven solution should also ensure that all audit trails are revalidated with each software update.
- Risk of data loss, tampering, or unauthorized modification is reduced, which promotes the reliability and accuracy of data throughout records' life cycles.
- Data integrity is continually upheld.
Conclusion
21 CFR Part 11 compliance is a critical requirement for companies doing business in FDA-regulated industries. The fact that compliance failures can have severe ramifications emphasizes the importance of implementing robust digital solutions for compliance.
Purpose-built software makes it easier to adhere to 21 CFR Part 11 compliance requirements, enabling companies to create, manage, and maintain compliance records and processes efficiently. By implementing modern digital tools to conduct compliance-related processes, life sciences companies can streamline their operations, mitigate risks, and focus on their ultimate objective: delivering high-quality products faster without risking noncompliance with FDA regulations.
To learn more about streamlining your organization’s compliance efforts with a modern FDA compliance software solution, download MasterControl’s 21 CFR Part 11 summary.
James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.
