Best Manufacturing Software for Healthcare in 2026

Device history record (DHR) management is a core FDA requirement for medical device manufacturers. Every production batch or unit must have a complete record documenting all manufacturing steps, materials used, in-process test results, operator identifications, and environmental conditions during production. The manufacturing system must generate and maintain these records automatically as production progresses, not require manual compilation after the fact.

Process validation and change control are critical in regulated manufacturing. Once a production process is validated, any changes to materials, equipment, procedures, or environmental conditions require formal change control procedures that include risk assessment, validation planning, and regulatory notification. The manufacturing system must enforce change control workflows and maintain the documentation that regulators will review during inspections.

Complaint handling and post-market surveillance connect manufacturing data to field performance. When a product complaint is received, the investigation must trace back to the specific production batch, examine manufacturing records for deviations, and determine whether corrective action is needed. The manufacturing system must support this backward traceability from customer complaint to production records.