Compliant Batch Records for Every Production Run
Create, review, and manage production batch documentation with confidence. Achieve FDA cGMP compliance with electronic batch records, digital signatures, and complete audit trails for every manufacturing batch.
Complete Batch Record Management Capabilities
Everything you need for compliant production documentation and batch record review
Electronic Batch Records
Replace paper batch records with digital documentation that captures every production step. Ensure consistency across batches with master batch record templates.
- Master batch record templates
- Step-by-step production instructions
- In-process data capture
- Real-time batch progress tracking
FDA cGMP Compliance
Meet 21 CFR Part 11 requirements with electronic signatures, audit trails, and access controls. Document every production decision for regulatory inspections.
- 21 CFR Part 11 compliant signatures
- Complete audit trail logging
- Role-based access controls
- Tamper-evident records
Batch Record Review & Approval
Streamline quality review with digital batch record workflows. Route records through approval chains with exception flagging and deviation management.
- Multi-level approval workflows
- Exception-based review
- Deviation documentation
- Electronic reviewer signatures
Real-Time Production Data Capture
Capture production data as it happens with mobile devices and barcode scanning. Eliminate transcription errors and ensure data integrity.
- Mobile data entry
- Barcode scanning integration
- Equipment readings capture
- Photo and document attachments
Lot & Material Traceability
Link batch records to incoming lot numbers and outgoing finished goods. Maintain complete traceability for recalls and compliance audits.
- Raw material lot tracking
- Finished goods lot assignment
- Forward and backward traceability
- Certificate of analysis linking
Automated Calculations & Checks
Build validation rules into batch records to catch errors before they happen. Automate yield calculations, material usage, and specification checks.
- Automated yield calculations
- Specification limit checks
- Material balance verification
- Required field enforcement
Why Manufacturers Choose Fiddle for Batch Records
Reduce documentation errors, accelerate batch release, and ensure compliance
Faster Batch Release
Reduce batch record review time by up to 80% with exception-based review and automated data validation. Release products to market faster.
Audit-Ready Documentation
Be prepared for FDA inspections with complete, tamper-proof batch records that demonstrate cGMP compliance at every production step.
Eliminate Documentation Errors
Replace handwritten records with digital data capture. Enforce required fields and validation rules to ensure complete, accurate documentation.
Complete Production Visibility
Track batch status in real-time across all production lines. Know exactly where every batch stands in the manufacturing process.
21 CFR Part 11 Compliance
Meet FDA electronic record requirements with secure authentication, electronic signatures, and complete audit trails for all record changes.
Streamlined Quality Review
Route batch records through approval workflows automatically. Flag exceptions for review and document deviations with corrective actions.
Trusted by Manufacturers for Batch Documentation
See how manufacturers achieve compliance and efficiency with Fiddle batch records
Our batch record review time dropped from 3 days to 4 hours. The exception-based review means quality only needs to look at what matters, not every single data point.
During our last FDA inspection, the auditor was impressed with how quickly we could pull any batch record and show the complete history. Fiddle made us audit-ready.
Ready for Paperless Batch Records?
See how Fiddle's batch record management software can streamline your production documentation and ensure FDA cGMP compliance. Schedule a personalized demo today.