Production Record Management

Compliant Production Records for Every Production Run

Create, review, and manage production documentation with confidence. Achieve FDA cGMP compliance with electronic production records, digital signatures, and complete audit trails for every manufacturing batch.

Production record management software showing production documentation, electronic signatures, and compliance tracking

Complete Production Record Management Capabilities

Everything you need for compliant production documentation and production record review

Electronic production record interface showing digital production checklist and master production record template

Electronic Production Records

Replace paper production records with digital documentation that captures every production step. Ensure consistency across batches with master production record templates.

  • Master production record templates
  • Step-by-step production instructions
  • In-process data capture
  • Real-time batch progress tracking
FDA cGMP compliance dashboard showing 21 CFR Part 11 electronic signatures and audit trail

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
Electronic signature workflow showing digital signature capture, 21 CFR Part 11 compliant approval workflow, and signature audit trail

Production Record Review & Approval

Streamline quality review with digital production 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
Production record review workflow showing multi-level approval chain and exception-based review

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
Real-time production data capture on mobile device with barcode scanning integration

Lot & Material Traceability

Link production 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
Lot and material traceability diagram showing raw materials to finished goods tracking

Automated Calculations & Checks

Build validation rules into production 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 Production Records

Reduce documentation errors, accelerate batch release, and ensure compliance

Faster Batch Release

Reduce production 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 production 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 production records through approval workflows automatically. Flag exceptions for review and document deviations with corrective actions.

Trusted by Manufacturers for Production Documentation

See how manufacturers achieve compliance and efficiency with Fiddle production records

"Our production 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."

QM
Quality Manager
Quality Manager, Pharmaceutical Manufacturer

"During our last FDA inspection, the auditor was impressed with how quickly we could pull any production record and show the complete history. Fiddle made us audit-ready."

CD
Compliance Director
Compliance Director, Dietary Supplement Company

Ready for Paperless Production Records?

See how Fiddle's production record management software can streamline your production documentation and ensure FDA cGMP compliance. Schedule a personalized demo today.