Medical Device and Pharmaceutical manufacturers produce products that improve and save lives every day. Products must be of the highest quality to meet customer demands for safety and efficacy. In addition, Medical Device and Pharmaceutical manufacturers must meet stringent government regulations and oversight while managing an increasingly global supply chain.
As a quality manager for a Medical Device or Pharmaceutical manufacturer, you need to:
Medical and Pharmaceutical SPC quality control keeps manufacturing processes operating at the highest efficiency. Raw materials and subcomponents for medical devices and pharmaceuticals are expensive. Finding defects late in production increases scrap and rework along with shipment delays. Quality managers need to proactively prevent defects by monitoring processes closely at the earliest production stages. With InfinityQS ProFicient SPC software, quality managers gain visibility to automated, real-time production-floor data collection, alerts, monitoring, and analysis that:
The ProFicient On Demand cloud quality management solution enables global real-time visibility of not only your own plants, but also the raw materials or subcomponents before they ever leave our suppliers’ facilities, no matter where they are located. This level of supplier monitoring prevents nonconforming materials from entering your production process, eliminating the need for acceptance sampling and reducing inventory.
Compliance with government regulations such as the U.S. Food and Drug Administration (FDA), European Union directives, the European Medicines Agency (EMA), and Health Canada is a given for Medical Device and Pharmaceutical manufacturers. InfinityQS ProFicient SPC software provides quality managers with real-time documentation and reporting, product traceability, and validation of software to:
ProFicient also offers Audit Trail Logging which provides a history of all changes made to any database record including sample data limits, alarm rules, change history, metadata, specification limits, and control limits.
Lot Genealogy reports provide a complete view of the incoming/outgoing product relationship complete with statistical summary information.
ProFicient’s Lot Genealogy and Reporting functionality enables Medical Device and Pharmaceutical manufacturers to track raw materials or component lot codes throughout manufacturing operations. For investigation purposes, genealogical "trees" can be created for any lot. These reports allow you to determine:
Additionally, InfinityQS maintains a comprehensive statistical validation of our SPC software products to ensure the accuracy and validity of the calculations performed within. This statistical validation is performed by our staff of degreed Industrial Statisticians and made available in electronic format suitable for inclusion by our FDA-regulated clients in their own validation documentation. This data helps maintain efficient medical quality control in a global supply chain.