Medical Devices and Pharmaceuticals

Reduce product defects, lower manufacturing costs, and achieve regulatory compliance

Making a quality product at the lowest cost is always a challenge. Add to that a host of regulatory requirements and you very quickly have a workforce that is overburdened, stressed, and struggling to keep up. Companies in the medical devices and life sciences industry often have hundreds of critical Quality tests to track during production and, in many cases, they must maintain that data for a long period of time. Their operations may include various machining processes, plastic molding, chemical mixing, lab analysis, assembly, packaging, and others. Attempting to apply SPC using paper or Excel is a common starting point. But these manual methods require a lot of overhead and offer very little help in identifying root causes. Automating your SPC activities can reveal hidden variations in a process, provide timely feedback to trends and patterns that lead to defects, and reduce the inaccuracy that is common with paper-based solutions.

DataNet combines Six Sigma, SPC, and FDA 21 CFR Part 11 expertise with award-winning SPC software and implementation/validation services. Our WinSPC software can predict and prevent defects during the manufacturing process. While traditional quality control methods tend to identify failures too late–after defective products have been produced or shipped–real-time SPC applications enable instant insight into your process, giving your operators and engineers an opportunity to correct and control process variations that lead to defective products. WinSPC meets FDA 21 CFR Part 11 requirements for electronic signatures through its built-in audit trails, advanced security controls, traceability support, and database management. Implementing WinSPC into your production environment allows you to improve product and process control while assuring compliance to regulatory requirements. DataNet offers manufacturers a fast, turnkey approach. Our solution delivery services provide installation, configuration, custom integration, and software validation services and our solutions and services have successfully passed third-party audits for compliance.

With WinSPC, manufacturers and suppliers in the medical devices and pharmaceutical industries are able to:

• Improve product and process quality
• Improve product release cycles
• Lower the cost-of-quality
• Meet FDA 21 CFR Part 11 compliance
• Provide system-wide audit trails
• Prevent product defects and recalls

Additional Information for this Industry

• DataNet Enhances Software Validation Toolkit and Services for WinSPC Quality Control Software
• Real-time Statistical Process Control & Analysis for the Life Sciences Industry (PDF)

Customers in this Industry

• Medical Device and Pharmaceutical Manufacturers Choose WinSPC Statistical Process Control Software
• Pharmaceutical and Medical Device Manufacturers to Achieve Highest Quality Standards with DataNet