In highly regulated industries like medical device and pharmaceuticals, products must be of the highest quality to meet customer demands for safety and efficacy. With Advantive’s robust medical and pharmaceutical ERP and SPC software, we can help you improve product quality while meeting stringent government regulations.
Keep manufacturing processes operating at the highest efficiency with our flexible medical device and pharmaceutical ERP and SPC solutions. With built-in medical quality control and supplier monitoring functionality, our software helps medical device and pharmaceutical manufacturers comply with government regulations and industry standards for quality and safety. Core features include:
Use access logs to track individual user access into and out of applications, and track and report security violations by individual users and their location with security violation logs. Advantive’s strict access control features support all of FDA 21 CFR Part 11 technical requirements for electronic signatures including password aging, recycling, lockouts, length, and encryption.
Track raw materials or component lot codes throughout manufacturing operations with our powerful lot genealogy and reporting tools for medical device and pharmaceutical manufacturers. These reports allow you to determine:
Built-in checklists and workflow-alerting features help medical device and pharmaceutical manufacturers easily comply with Hazard Analysis and Critical Control Points (HACCP), Standard Operating Procedures (SOP), Critical Quality Attributes (CQAs) and Critical Process Parameters (CPP). With our powerful quality management solutions, you can also set reminders of when to perform HACCP, SOP, and other critical quality checks by incorporating workflow requirements at the production floor level and using our real-time dynamic scheduler, which offers visual checklists to operators.
Manufacturers in the pharmaceutical industry must also comply with FDA, U.S. Pharmacopoeia (USP), or other international Pharmacopoeia requirements for Net Weight Control and Content Uniformity. The Net Weight Control feature supports Pharmacopoeia Weight Variation and Content Uniformity requirements; in addition, our software provides related documentation and reporting to support the needs of global manufacturers.
We provide test cases, validation scripts, and validation services so that medical and pharmaceutical manufacturers can perform full, functional verifications of their software installations. These scripts provide a solid foundation for clients to validate our SPC quality system internally.
Additionally, we maintain 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.
Learn how the world’s leading producer of implantable hearing devices improved quality control and increased real-time visibility across production with InfinityQS SPC software.