How to Maintain Compliance with 21 CFR Part 11 in Imaging Research
If your organization conducts drug trials, medical device validation or other regulated studies, you’re subject to FDA requirements for auditability and electronic record integrity. To meet the regulation known as 21 CFR Part-11, your electronic records and electronic signatures need to be as trustworthy as paper records.
When it comes to research that involves medical imaging, meeting that requirement can be challenging due to the complexity involved with large imaging files, multisite inputs, complex processing pipelines and distributed collaboration. Below, we detail everything organizations need to do to get their imaging data audit-ready for the FDA and other regulatory bodies.
1. Data Integrity and Workflow Transparency
When managing and analyzing imaging data under 21-CFR- Part-11, you'll need to ensure your data is accurate, traceable and tamper-proof. This aligns with FDA expectations under the ALCOA data integrity principles: attributable, legible, contemporaneous, original and accurate. And it applies to metadata as well, like timestamps, user IDs and instrument IDs.
Compliance doesn’t just apply to the data itself but also to your data management and analysis workflows. This means:
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Clearly defining and documenting each step of your imaging workflows, from ingest to quality check, processing, analysis, review and ETL/export.
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Tracking each change made to the data or metadata, with time-stamped logs and user attribution.
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Locking data versions when analysis is complete or when preparing for regulatory submission to preserve fidelity.
Reviewing data isn’t unlike reading a book; reviewers are looking to see the full story, from start to finish. This means your system must automatically capture and preserve data lineage, so reviewers can trace how every dataset moved from raw upload to final endpoint. Ensuring data provenance is what helps you ensure compliance with 21 CFR Part 11.
2. Access Controls and Security
With clearly defined access controls, only authorized users may view, upload or edit images. This should include instituting:
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Strong authentication
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Role-based privileges
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Password policies
While multi-factor authentication (MFA) isn’t mandated by the FDA, it’s a solid practice to ensure you’re reaching other elements of security and compliance.
3. Audit Trails
While defining data access and workflows is crucial, it doesn’t do you any good if you can’t readily retrieve those records and create a report in the event of an audit. That’s where audit trails come in.
Having an audit trail means there’s a record of any action taken with the data you’re submitting, such as creating, modifying, or deleting imaging data or metadata. These changes must be logged by the system you’re using in a secure, computer-generated, time-stamped trail that captures who performed the change, when it occurred, what changed and why the change was made.
It's not enough to capture new data with updated changes. Your audit trail must also preserve prior values and keep easily viewable records of them.
4. Electronic Signatures
Meeting 21 CFR Part 11 compliance also means any electronic signatures used in imaging studies need to be as trustworthy as their handwritten counterparts. Essentially, electronic signatures must be:
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Unique to each individual and not reused or reassigned
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From an individual who’s been verified by the system you’re using
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As legally binding as handwritten signatures, with FDA certification requiring a handwritten signature and submission
5. Record Retention and Retrieval
Your records need to stay intact and be retrievable in a human-readable format for the required retention period. For clinical trials, data should be kept for at least two years after the last disposition of the research drug. And with manufacturing records, they need to be retained for up to seven years beyond the product’s expiration.
For this reason, you need a system that can readily store records along with their associated metadata in a validated format for as long as needed. That means being able to scale as new data comes in while maintaining validated records.
Best Practices to Implement Compliance
Here are some of the best ways to ensure you’re meeting compliance with 21 CFR Part 11.
Document SOPs and Workflows
Define standard procedures for how images are ingested, processed, reviewed and stored. SOPs should cover change control, access protocols, signature usage, backup/retention and system validation.
Automate Provenance and Pipelines
Use systems that automatically log each transformation step in your imaging pipeline, associating records with user identity and timestamps.
Ensure Legible Traceability
Make sure your audit trails can be easily read by regulators or auditors without needing specialized tools.
Vendor Validation
If you're using a third-party imaging or data platform, verify that the vendor supports 21 CFR Part 11 compliance and has strong security controls and history in the imaging space.
Regular Compliance Audits
Schedule recurring internal reviews of audit logs, user activity, access controls, signature use and change control practices. Proactively flag irregularities or unauthorized changes.
How Flywheel Supports These Needs
Here’s how Flywheel Validated Core addresses each of the key Part-11 requirements and helps you build compliant, auditable imaging workflows:
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End-to-end solution: Flywheel makes documenting every step of your studies easy with built-in tracking features, from ingest to submittal.
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Access control and security: Role-based permissions and authentication supports secure workflows.
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Audit trails: Exportable, time-stamped audit logs showing user, action, timestamp, old/new values and rationale as part of our Audit Trail module, which is included in Validated Core or can be acquired separately in conjunction with Flywheel Core
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Data provenance: SOP-defined workflows and data provenance help you ensure reproducibility.
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Electronic signatures: Data changes and approvals are logged with digital signatures attached to records.
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Record locking: Ability to lock dataset versions destined for regulatory submission.
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Secure collaboration: Cross-site access with consistent security and compliance safeguards.
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Scalability: Integration with major cloud providers helps you keep accurate records while scaling as new data emerges.
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Imaging expertise: We're helping several top 20 pharmaceutical organizations achieve their imaging data management goals, with better data access and control for faster, more secure submissions.
Flywheel Validated Core brings all these capabilities together in a unified, fully documented, 21 CFR Part-11-compliant environment, helping you minimize errors, save time and confidently leverage auditable imaging data for regulatory review. Interested in how Flywheel Validated Core can simplify compliance for you? Ask about a demo or compliance package tailored to your workflow needs.