FDA & cGMP Compliance Built Into Every Workflow
Meet FDA and cGMP requirements with confidence. Fiddle provides 21 CFR Part 11 compliant electronic records, complete lot traceability, electronic batch records, and audit-ready documentation for food, supplement, and cosmetics manufacturers.
Complete FDA & cGMP Compliance Capabilities
Everything you need to meet FDA regulations and cGMP requirements for manufacturing
21 CFR Part 11 Electronic Records
Meet FDA electronic record requirements with secure authentication, electronic signatures, and tamper-evident audit trails. Every record change is documented with user attribution and timestamps.
- Secure user authentication and access controls
- Electronic signatures with signer identification
- Complete audit trail for all record changes
- Tamper-evident record storage
cGMP Batch Records
Create, review, and approve production batch records that meet cGMP documentation requirements. Master batch record templates ensure consistency across all production runs.
- Master batch record templates
- Step-by-step production instructions
- In-process data capture and verification
- Multi-level batch record approval workflows
Complete Lot Traceability
Track every ingredient and product through your entire supply chain. Achieve FDA traceability requirements with forward and backward lot tracking for instant recall readiness.
- Forward and backward lot traceability
- Raw material to finished goods tracking
- Instant recall impact analysis
- Supplier lot documentation
Quality Control & Testing
Document quality inspections, testing results, and specifications throughout production. Ensure every batch meets quality standards before release.
- Quality inspection checklists
- Specification limit tracking
- Certificate of analysis generation
- Deviation and CAPA documentation
Audit Trail & Documentation
Maintain complete, audit-ready documentation for FDA inspections. Every action is logged with who, what, when, and why for full regulatory transparency.
- User-attributed action logging
- Timestamped record changes
- Document version control
- Inspection-ready reporting
Compliance Automation
Reduce compliance burden with automated workflows that enforce cGMP requirements. Built-in validation rules ensure documentation is complete before proceeding.
- Required field enforcement
- Automated approval routing
- Expiration date tracking and alerts
- Compliance exception flagging
Why FDA-Regulated Manufacturers Choose Fiddle
Reduce compliance risk, streamline audits, and focus on manufacturing great products
Audit-Ready, Always
Be prepared for FDA inspections at any time with complete documentation, audit trails, and instant access to batch records and traceability data.
Reduce Compliance Burden
Automated workflows and built-in validation rules reduce manual compliance tasks by up to 60%, freeing your team to focus on production.
21 CFR Part 11 Compliant
Meet FDA electronic record requirements out of the box with secure authentication, electronic signatures, and tamper-evident audit trails.
Complete Traceability
Track every ingredient and product through your supply chain. Execute recalls in minutes with instant impact analysis and affected customer identification.
Eliminate Documentation Errors
Replace paper records with digital documentation that enforces completeness and accuracy. Catch errors before they become compliance issues.
Faster Batch Release
Accelerate batch review and release with exception-based review workflows. Reduce batch release time from days to hours.
Trusted by FDA-Regulated Manufacturers
See how food, supplement, and cosmetics manufacturers achieve compliance with Fiddle
Our FDA auditor was impressed with how quickly we could pull any batch record and trace every ingredient back to its source. Fiddle made our last inspection our smoothest ever.
Before Fiddle, cGMP compliance was a constant struggle with paper records and spreadsheets. Now everything is documented automatically, and we can focus on making great products instead of paperwork.
Ready for Stress-Free FDA Compliance?
See how Fiddle's FDA and cGMP compliance software can simplify regulatory requirements and give you confidence during audits. Schedule a personalized demo today.