Medical Devices The Medical Device Industry as well as the whole Pharmaceutical Industry is facing ever increasing requirements for productivity improvement. Partially due to stringent FDA regulations for electronic records and a fairly conservative approach to quality assurance has forced these industries to be left behind in productivity improvement driven by the latest information technology revolution. These regulations are a new set of best practices and industry guide lines called Process Analytical Technology (PAT). The idea behind PAT is to introduce a new Risk Based Approach for taking traditional Quality Assurance to the next level. In this approach, the advanced quality statistics as well as modern web centric IT solution architectures are necessary means to help organizations adopt to the new paradigm.

Predisys solutions deliver the following capabilities for manufacturers in the medical device industry:

• Quality information can be utilized online in R&D, material sourcing and by customers.
• SPC Everywhere – online web based SPC analysis tools provided on every desktop
• Increased effectiveness of automated test and measurement systems
• Less problems with measurement variability though automated Gage R&R and MSA
• Reduced cost of compliance  – especially FDA CFR 21 Part 11
  • Electronic Signatures
  • Audit Trails
  • Global user privilege management based on Microsoft Active Directory
• Paperless Manufacturing Traceability Document Application (PMTDA)
  • Built on MS Office InfoPath digital document technology and SharePoint
  • Fully compliant with FDA regulations
  • Customizable forms by local key users
• Much less manual quality reporting work through report automation
• Multi-location visibility to R&D, material sourcing, customers, suppliers etc.
• Corrective and Preventive Actions management on a standard SharePoint platform
• Collaboration and messaging between and within different plant departments
• Manufacturing KPI dashboards generated automatically in the Microsoft BI platform