FDA Compliance with Sprint GMP
The Food and Drug Administration regulates food, drugs, medical devices, and cosmetics in the United States. FDA compliance requires strict record keeping, traceability, and quality control. Sprint GMP helps manufacturers meet FDA requirements through comprehensive batch tracking and documentation.
FDA Requirements
FDA regulations vary by product type but generally require manufacturers to maintain detailed records of production, quality control, and distribution. Food manufacturers must comply with Food Safety Modernization Act (FSMA) requirements, while medical device manufacturers must follow Quality System Regulation (QSR) requirements.
Sprint GMP Features for FDA Compliance
Batch Records
FDA requires complete batch production records showing all materials used, processing steps, and quality control results. Sprint GMP automatically creates batch records with full traceability, linking every raw material lot to the finished product batch.
FDA Requirement: Maintain complete batch production and control records.
Material Traceability
FDA requires the ability to trace materials from receipt through production to finished product distribution. Sprint GMP provides complete forward and backward traceability, allowing you to quickly identify all batches affected by a material issue or trace a finished product back to its source materials.
FDA Requirement: Maintain records to trace materials and finished products.
Complaint and Adverse Event Reporting
FDA requires systematic complaint handling and adverse event reporting. Sprint GMP tracks complaints, links them to specific batches, documents investigations, and maintains records required for FDA reporting. The system helps you identify trends and take corrective action.
FDA Requirement: Establish procedures for complaint handling and adverse event reporting.
Recall Procedures
When recalls are necessary, FDA requires rapid identification of affected products. Sprint GMP's recall capability instantly identifies all batches affected by a material or quality issue, enabling fast and effective recall execution.
FDA Requirement: Establish procedures for product recall when necessary.
Key FDA Compliance Features
- Complete batch production records
- Full material and product traceability
- Complaint and adverse event tracking
- Rapid recall capability
- Quality control test records
- Document management for certificates and test reports
Achieve FDA Compliance
Sprint GMP provides the record keeping and traceability foundation for FDA compliance. Start your free trial to see how our system can help you meet regulatory requirements.
Start Free Trial