FDA 21 CFR Part 11 is the US Food and Drug Administration regulation that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records.
FDA 21 CFR Part 11 is the United States Food and Drug Administration regulation that sets the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper. For any organisation generating monitoring records that fall under FDA oversight, Part 11 governs how those records must be secured, controlled and retrieved.
Part 11 is about the integrity and control of electronic data — secure, validated records; a complete audit trail of user actions; tamper-evident storage; and, where required, electronic signatures. Seemoto supports compliant electronic-records workflows through encrypted storage, role-based access control and a tamper-evident audit trail. Importantly, supporting Part 11 workflows is a different claim from being 'FDA validated': formal system validation is a separate professional service, scoped to your requirements.
What FDA 21 CFR Part 11 requires
Secure, validated electronic records
Electronic records must be accurate, reliable and protected throughout their retention period.
Audit trail of user actions
A secure, computer-generated, time-stamped audit trail must record operator actions that create, modify or delete records.
Tamper-evident storage
Records must be protected to enable accurate, ready retrieval and to detect alteration.
Access control
System access must be limited to authorised individuals, with attributable user accounts.
Electronic signatures
Where electronic signatures are used, they must be unique, verifiable and linked to their records.
How Seemoto supports FDA 21 CFR Part 11
Secure electronic records
Encrypted data transmission and storage on a secure, EU-hosted cloud platform, retrievable and exportable for inspection.
Tamper-evident audit trail
A time-stamped audit trail records system events and user actions, supporting the integrity Part 11 expects.
Role-based access control
Access is limited to authorised, individually attributable users with permission levels per role.
Electronic signature support
Electronic signature workflows are supported for report release where your procedures require them.
Readiness assessment
Seemoto provides a Part 11 readiness assessment and gap analysis covering audit trail, data integrity and electronic-signature requirements.
What's included vs. what's a service
Transparency matters in regulated buying. Here is exactly what comes with a standard Seemoto monitoring subscription, and what is delivered as a separately scoped professional service.
Included by default
- Encrypted data storage and transmission
- Role-based user access control and audit log
- Exportable electronic records
- Tamper-evident, time-stamped data
Professional services (scoped separately)
- Formal system validation documentation (IQ/OQ/PQ)
- FDA 21 CFR Part 11 readiness assessment & gap analysis
- Electronic signature implementation where required
- Validated compliance report packages
Where FDA 21 CFR Part 11 applies
Primary sectors: US-facing pharma · Biotech & cell/gene therapy · Clinical research · Regulated laboratories
Related solutions
Related industries
Frequently asked questions
No — and those phrasings should be avoided. Seemoto supports compliant electronic-records workflows under 21 CFR Part 11 through encrypted storage, access control and a tamper-evident audit trail. Formal system validation, which is what demonstrates Part 11 compliance for a specific installation, is a separate professional service scoped to your requirements.
The platform maintains a secure, time-stamped audit trail of system events and user actions, with each action attributable to an authenticated user. Records are tamper-evident and exportable, supporting the ready retrieval and integrity that Part 11 inspections require.
Electronic signature workflows are supported for report release where your SOPs require them. Implementation specifics are confirmed as part of a validation or readiness engagement.
The Seemoto cloud platform is EU-hosted with encrypted transmission and storage, role-based access control and GDPR-aligned data handling, with 5-year retention as standard.
FDA 21 CFR Part 11 guides & resources
Practical, vendor-neutral guides related to FDA 21 CFR Part 11 compliance and temperature monitoring.
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Read guide →Dedicated Compliance Monitoring vs Generic IoT Platforms
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Read guide →References & further reading
- FDA — 21 CFR Part 11, Electronic Records; Electronic Signatures
- FDA Guidance — Part 11, Electronic Records; Electronic Signatures — Scope and Application
This page is general guidance, not regulatory or legal advice. Seemoto supports the requirements these frameworks enforce; achieving compliance depends on your full quality system. Confirm specific obligations with your competent authority or quality team.
Talk to us about FDA 21 CFR Part 11 monitoring
Tell us about your environment and compliance goals. We'll map your requirements to the right monitoring setup and confirm any validation or documentation scope up front.