FDA 21 CFR Part 11 compliance
Electronic records and signatures for life sciences and healthtech
Satisfy FDA Title 21 CFR Part 11 with tamper-evident audit trails, dual-component electronic signatures, and computerized system validation (CSV).
What FDA 21 CFR Part 11 is
Title 21 CFR Part 11 of the Code of Federal Regulations establishes FDA criteria for trustworthy, reliable electronic records and electronic signatures.
It applies to biotechnology, pharmaceutical, and medical device companies using digital systems to manage GxP data submitted to or inspected by the FDA.
Mandatory requirements include closed-system authority checks, operator-independent computer-generated audit trails, and cryptographically verified signatures.
Who needs FDA 21 CFR Part 11
You develop software, medical devices, laboratory instruments, or clinical trial platforms used in FDA-regulated pharmaceutical and medical device environments.
How TrustLynce helps with FDA 21 CFR Part 11
Immutable audit trails
Automatic, secure recording of date/time of operator entries and actions that create, modify, or delete records.
Dual-component e-signatures
Enforce two distinct authentication factors (such as credentials and MFA token) for document execution.
Authority & sequence checks
Enforce operational workflows and role-based permissions preventing unauthorized state transitions.
FDA 21 CFR Part 11 questions
It can hold the evidence. Control records and documentation can be organized to support a GAMP 5 risk-based validation, but the validation itself, and the judgment calls in it, stay with your quality team. Ask us for specifics before you rely on it.
The signer printed name, the date and time of execution, and the formal meaning (such as review, approval, responsibility, or authorship).
Other frameworks
Evidence collected for one framework carries into the next.
SOC 2
The one your buyers ask for
ISO 27001
Recognised worldwide
HIPAA
Protect health information
GDPR
Handle EU personal data
PCI DSS
Take card payments safely
ISO 42001
Govern how you use AI
NIST CSF
A common security language
CMMC
Work with the DoD
Custom
Your own control set
ISO 27701
Privacy extension to ISO 27001
DORA
EU financial operational resilience
NIS 2
EU critical infrastructure cybersecurity
CCPA / CPRA
California comprehensive privacy
FERPA
Student education privacy standard
HDS Certification
French health data hosting certification
SOX ITGC
IT controls for public companies
HITRUST CSF
Assurance healthcare buyers ask for
FedRAMP
Sell cloud services to US agencies
NIST SP 800-53
The federal security control catalog
NIST SP 800-171
Protect CUI on federal contracts
Find out what your compliance program actually looks like
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