Navigating 21 CFR Part 11

Data integrity is crucial to getting the most out of the information available within your organization, however its importance goes beyond simply being good practice. For life sciences companies, and others in highly regulated spaces, data integrity is a regulatory requirement. In the U.S., it’s governed under the Food and Drug Administration (FDA) 21 CFR Part 11 regulation. Let’s delve into what this regulation entails and how it impacts your validation processes.

What Is FDA 21 CFR Part 11?

The FDA 21 CFR Part 11, often abbreviated as Part 11, sets forth the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and equivalent to paper records. Enacted in 1997, this regulation was a response to the increasing use of electronic records and signatures in FDA-regulated industries.

Key Components of FDA 21 CFR Part 11:

Validation of Systems: Part 11 requires that electronic systems used to generate, modify, maintain, archive, retrieve, or transmit electronic records must be validated. This includes software and hardware validation to ensure that systems consistently produce accurate and reliable results.

Audit Trails: Systems subject to Part 11 must have robust audit trail functionality. These audit trails should record any changes to electronic records, including who made the change, when it was made, and the reason for the change. Audit trails serve as a critical tool for ensuring data integrity and traceability. There are key differences between audits and inspections, but both require this audit trail.

Electronic Signatures: Part 11 defines the criteria for electronic signatures to be considered equivalent to handwritten signatures. Electronic signatures must be unique to the individual, securely managed, and linked to their respective electronic records. This requirement ensures accountability and prevents unauthorized access or alterations.

Access Controls: Systems must implement adequate access controls to prevent unauthorized individuals from accessing electronic records or electronic signature capabilities. This includes user authentication measures such as passwords, biometrics, or smart cards, as well as role-based access controls to restrict privileges based on job responsibilities.

Data Integrity and Security: Part 11 mandates measures to ensure the integrity and security of electronic records throughout their lifecycle. This includes protections against unauthorized access, data corruption, or loss, and data backup and recovery procedures.

Learn everything you need to know about Data Integrity compliance in our latest eBook: The Data Integrity Handbook. Download yours now!

The Data Integrity Handbook

DOWNLOAD NOW

ALCOA+

For life sciences and other regulated companies, data integrity is often synonymous with ALCOA+ principles.

• Attributable
  • Activity can be traced back to a specific individual
•  Legible
  • Data is readable and understandable
• Contemporaneous
  • Data is recorded in a timely manner 
• Original
  •  Documents must be originals or “true copies”
• Accurate
  • The data must accurately reflect what was recorded

 In recent years, ALCOA has expanded to ALCOA+, the new gold standard for data integrity with the addition of four new criteria:

• Complete
• Consistent
• Enduring
• Available

At a high level, these four additional principles reflect the need to maintain documentation in its entirety (Complete), ensure it is orderly and chronological (Consistent), stored for a significant period of time (Enduring), and accessible when needed (Available).

With the FDA’s increasing scrutiny of data integrity, life sciences companies are increasingly looking to digital validation as a means to provide the highest standard of controls — a trend reflected in the 2024 State of Validation report , which found nearly 90 percent of companies planned to adopt a digital solution or were currently using one.

Implications for Validation Professionals

Thorough Documentation: Validation professionals must meticulously document all aspects of system validation, including testing protocols, results, and deviations. Detailed documentation provides evidence of compliance and facilitates regulatory inspections. This is a key component of any FDA inspection.

Continuous Monitoring and Maintenance: Compliance with Part 11 is an ongoing process. Validation professionals should implement regular monitoring and maintenance activities to ensure that systems remain in a validated state and continue to meet regulatory requirements.

Collaboration Across Functions: Achieving and maintaining compliance with Part 11 requires collaboration across various functions within an organization, including IT, quality assurance, and regulatory affairs. Validation professionals play a crucial role in facilitating communication and alignment between these stakeholders.

Stay Informed: Regulatory requirements and industry best practices evolve over time. Validation professionals must stay informed about changes to Part 11 and other relevant regulations, as well as emerging technologies and trends that may impact validation processes.

Data Integrity Through Digital Validation

To ensure compliance, data integrity should be baked into every step of validation and manufacturing. A digital validation solution, such as Kneat Gx, is a great way to make this happen.

The following table represents what you should expect and how that expectation is met by Kneat’s digital validation platform Kneat Gx.