Medical and Pharmaceutical Manufacturing Software Solutions

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:

• Materials used in the production of a specific finished lot
• Where incoming raw materials were consumed
• Root causes of nonconforming lots
• Information critical for responding to product recalls
• Which final lots were created from incoming lots
• Information critical for counterfeit prevention and response
• Unique Device Identification (UDI) information necessary for future FDA medical device labeling requirements
• Current pharmaceutical quality assurance status

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.