Manufacturing for Medical Devices

The Manufacturing app for Healthcare provides electronic batch records and device history records that satisfy FDA documentation requirements. Every production step is documented with operator identity, timestamp, material lot numbers, equipment used, and in-process test results. These records are maintained in a format that supports FDA inspection and audit requirements without the filing cabinets of paper records that traditional approaches require.

Change control management ensures that no modification to a product, process, or procedure occurs without proper evaluation and approval. Design changes, process parameter adjustments, material substitutions, and equipment modifications all follow documented change control procedures. The system tracks each change request through evaluation, approval, implementation, and effectiveness review.

Equipment qualification and validation tracking maintains the IQ, OQ, PQ documentation for every piece of production equipment. Calibration schedules, preventive maintenance records, and equipment logbooks are maintained electronically. When equipment is due for requalification or calibration, the system prevents its use in production until the required activities are completed and documented.