In the life sciences industry, data is central to regulatory compliance, product quality, and patient safety. As organizations continue shifting from paper-based to digital systems, FDA 21 CFR Part 11 remains one of the most important regulations governing how electronic records and signatures are used, stored, and managed.
In 2025, the need for secure, validated, and audit-ready systems is greater than ever.
Whether you’re evaluating a new quality management system or reassessing your existing processes, understanding how Part 11 applies to your operations is essential.
What Is 21 CFR Part 11?
21 CFR Part 11 is a regulation established by the U.S. Food and Drug Administration (FDA) that defines the criteria under which electronic records and electronic signatures are considered equivalent to paper records and handwritten signatures.
The rule applies to all FDA-regulated industries—including pharmaceutical, biotechnology, and medical device companies—that use electronic systems to manage records required by FDA regulations.
Key areas covered by Part 11 include:
- System validation
- Audit trails
- Access controls
- Electronic signatures
- Record retention and retrieval
Why It Still Matters in 2025
Digital transformation is no longer optional. Cloud-based systems, remote audits, and global collaboration are now standard across life sciences. Yet despite advances in technology, the core regulatory expectations under Part 11 have not changed.
The FDA continues to enforce Part 11 compliance during inspections. Companies that fail to demonstrate proper controls around electronic records and signatures may face warning letters, Form 483 observations, or more serious enforcement actions.
What’s new is the regulatory scrutiny of hybrid systems—those that combine manual processes with electronic records. If your system lacks validation, security, or traceability, it’s a liability.
Core Requirements of Part 11
Here’s what the FDA expects from systems managing electronic records and signatures:
1. Validation of Systems
Systems used to create, modify, maintain, or transmit electronic records must be validated to ensure accuracy, reliability, and consistent performance.
What this means:
- You must document how the system functions.
- You must demonstrate that it performs as intended under real-world conditions.
- Validation must be maintained over time, especially during system updates.
2. Audit Trails
Part 11 requires systems to generate secure, computer-generated, time-stamped audit trails that independently record who did what and when.
Audit trails must:
- Be tamper-evident
- Record actions like creation, modification, or deletion of records
- Be retained as long as the associated records
3. Access Control and Security
Only authorized individuals should have access to the system. The system must be capable of enforcing unique user IDs, password policies, and access restrictions based on role or function.
4. Electronic Signatures
Electronic signatures must be linked to their respective records and must:
- Clearly identify the signer
- Include the date/time of signing
- Indicate the meaning (e.g., approval, review, authorship)
Electronic signatures are legally binding and must be protected from falsification or unauthorized use.
5. Operational Controls and Documentation
Organizations must implement standard operating procedures (SOPs) governing:
- System usage
- Signature controls
- Security administration
- Record retention and backup
Users must be trained and qualified to operate the system under these SOPs.
Common Compliance Gaps
Despite its longevity, Part 11 remains a challenge for many organizations. Common compliance gaps include:
- Lack of complete system validation
- Missing or incomplete audit trails
- Use of shared logins or weak access controls
- Poor documentation of SOPs and user training
- Inconsistent electronic signature practices
Hybrid environments—where manual processes and electronic records coexist—pose additional risks, particularly when data is transferred across systems that are not integrated or validated.
What to Look for in a Part 11-Compliant eQMS
To maintain compliance, your electronic quality management system (eQMS) must be built to support all aspects of Part 11. That includes:
- A validated platform with documented testing protocols
- Secure audit trails that are automatic and tamper-evident
- Configurable access controls and user authentication
- Electronic signature workflows with traceable meaning and timestamps
- Built-in SOPs and templates to standardize compliance practices
Dot Compliance provides a pre-validated, Salesforce-native eQMS that eliminates the guesswork and accelerates compliance readiness.
Compliance Is a Shared Responsibility
Technology alone isn’t enough. The FDA expects organizations to combine compliant systems with clear policies, procedures, and training.
You’re responsible for:
- Documenting your system use and controls
- Ensuring users are properly trained and qualified
- Maintaining validation and audit readiness
Final Thoughts
21 CFR Part 11 compliance is not just a regulatory requirement—it’s a foundation for trust in your electronic records, signatures, and processes. In 2025, as digital systems become more deeply embedded in life sciences operations, the need for validated, secure, and transparent systems will only increase.
By choosing a quality management system designed for Part 11—and maintaining internal procedures that support it—you can help ensure your organization remains compliant, efficient, and inspection-ready.
Download our free 21 CF Part 11 checklist to help you streamline the process.
