ELIMINATE PAPER SIGNATURES WHILE STAYING FDA COMPLIANT
Password-authenticated electronic signatures with complete audit trails. Meet 21 CFR Part 11 requirements without the paper chase.
- Two-factor authentication: User ID + password for every signature
- Immutable audit trails: Know who signed what, when, and why
- Instant compliance reports: Generate signature logs in seconds
The Challenge
Paper signatures are killing your compliance efficiency
FDA inspectors arrive. You need to prove who approved every batch, when they signed off, and verify their authority to sign. But your records are scattered across filing cabinets, email attachments, and handwritten logs that take days to compile.
- Chasing paper signatures delays production and shipping
- Handwritten logs are illegible, incomplete, or missing entirely
- No way to prove signature authenticity during audits
- Training verification records buried in spreadsheets
- Hours spent compiling documentation for every inspection
The Solution
How CFR Part 11 Digital Signatures solves it
GrowerIQ replaces paper with password-authenticated electronic signatures that automatically generate compliant audit trails. Every signature is verified, timestamped, and linked to the exact activity.
Authenticate
Users enter their unique credentials to sign. Two-factor verification (User ID + password) ensures only authorized personnel can sign.
Sign & Timestamp
System records the signature with timezone-aware timestamp, user role, and links it to the specific activity or document.
Audit & Report
Generate comprehensive signature logs instantly. Complete traceability from signature to activity to batch record.
Process
How it works
Initiate Signature
Click to sign on any activity requiring authorization – SOPs, batch records, deviations, or processor activities.
Authenticate
Enter your unique User ID and password. Auth0 verifies your identity before the signature is accepted.
Record Signature
System captures user ID, timestamp, role, and links the signature to the specific activity in an immutable record.
Generate Audit Trail
Every signature automatically becomes part of the Master Batch Record with full traceability for inspections.
Features
Core capabilities
Password-authenticated signatures via Auth0 OAuth – no signature without verification
Two-tier approval workflows: Employee sign-off plus department head approval
Timezone-aware timestamps on every signature – no ambiguity for international operations
Signature logs with user ID, role, activity type, and document references
Master Batch Record integration – signatures automatically aggregated with related documents
Multi-tenant isolation – organization-level signature controls and audit trails
Use Cases
Who benefits from CFR Part 11 Digital Signatures
Quality & Compliance Teams
Generate audit-ready signature logs in seconds. Prove compliance with complete traceability from signature to activity to batch.
Operations & Production
Speed up approval workflows. No more chasing paper signatures – sign off on SOPs, batch records, and deviations from any device.
Regulatory Affairs
Meet FDA 21 CFR Part 11 requirements confidently. Demonstrate compliant electronic signatures during any inspection.
21 CFR Part 11 Alignment
Compliance and reporting impact
GrowerIQ’s digital signature system is designed to align with FDA 21 CFR Part 11 requirements for electronic records and signatures. Every signature creates an immutable, auditable record that regulators expect.
- Unique user identification for each signature (11.10)
- Two distinct identification components: User ID + password (11.200)
- Audit trails linking signatures to activities (11.10(e))
- Authority controls through role-based access (11.10(g))
Ecosystem
Part of the GrowerIQ ecosystem
Master Batch Records
Signatures automatically aggregated into complete batch documentation with full traceability.
Learn more →SOP Training
Two-tier signature workflow for employee acknowledgment and department head approval.
Learn more →Quality Management
Sign off on deviations, CAPAs, and QA activities with compliant electronic signatures.
Learn more →Results
Business impact
Faster Signatures
Signature collection compared to paper-based workflows
Traceable
Every signature linked to user, timestamp, role, and activity
Audit Prep Time
Audit-ready signature reports generated instantly
FAQ
Frequently asked questions
Does GrowerIQ meet FDA 21 CFR Part 11 requirements?
GrowerIQ’s digital signature system is designed to align with CFR Part 11 requirements including unique user identification, two-factor authentication (User ID + password), immutable audit trails, and authority controls through role-based access.
How are signatures authenticated?
Every signature requires the user to enter their unique credentials (username and password). Authentication is handled through Auth0 OAuth, ensuring secure verification before any signature is recorded.
What information is captured with each signature?
Each signature records: User ID (who signed), timestamp with timezone (when), user role (authority level), and links to the specific activity or document being signed. This creates a complete audit trail.
Can multiple people approve the same document?
Yes. GrowerIQ supports two-tier signature workflows – for example, an employee signs to acknowledge an SOP, then a department head signs to approve. Each signature is recorded separately with full attribution.
How do I generate signature reports for audits?
Navigate to the Signature Log from any module to see all signatures with filtering by date, user, document type, or activity. Export to CSV for audit documentation in one click.
Customer Reviews
Trusted by cannabis operators worldwide
Platform
Explore GrowerIQ Modules
CFR Part 11 Digital Signatures integrate seamlessly with the full GrowerIQ platform. Signatures connect directly to batch records, SOP training, and quality workflows.
Cultivation
Software that conforms to your operations
Manufacturing
Produce the best quality products
QMS
Connect your QA team to the rest of your operations
CRM
Track Accounts, Orders, and Shipments in one place
GACP/EU GMP
Capture new markets through high-quality standards
Reporting & Data
Multi-facility and team reporting in one place
See CFR Part 11 Digital Signatures in action
Ready to eliminate paper signatures while staying FDA compliant? Let us show you how GrowerIQ can transform your compliance workflows.
