Medical Device & pharmaceutical

Challenges

As a medical products and pharmaceutical manufacturer you face quality standards from initial design to assembly and post production. Regulation of these standards and whether you pass and fail comes from the industry, your corporate goals and ultimately your customers. So, how do you ensure your quality efforts are resulting in less recalls and waste?

Solutions

We have been working side by side with the world’s largest medical products and pharmaceutical manufacturers with software and hardware solutions for their quality concerns and to aid them in compliance with industry standards. The DATAMYTE solution provides a fully integrated quality management system.

Expertise

  • Quality Planning (APQP, Flow Chart, Control Plan, Work Instructions, PPAP, Reporting)
  • Supplier Management (Inspection Planning, Data Collection, Evaluation and Escalation, Incoming & Outgoing, Reporting)
  • Gage & Tool Management
  • SPC
  • Digital Checklist and Workflow Management
  • Complaint Management (Non Conformance Management)
  • Tools (ERP/SAP/MES Interface, Alarms and Notification, Control Center, Report Designer, Graphical Reporting, BOM, Electronic Signature, Action Management, Multitenancy, Scheduler, Curves, Audit Trail)

 

DataMetrics
Data Collection & SPC

Meeting CFR 21 Part 11 Compliance while helping you achieve your productivity goals

Solutions Across Work Areas

Planning

  • Document Management
  • Risk Management
  • Sub Supplier Part Approval

Production

  • Revolution and 600 Mobile Data Collectors
  • SPC & Data Collection
  • Digital Clipboard
  • Gage & Tool Management
  • Traceability

Audit / QA

  • Revolution and 600 Mobile Data Collectors
  • LIMS
  • Non-Conformance Management
  • Document Management
  • SPC & Data Collection
  • Digital Clipboard
  • Incoming / Outgoing Inspection
  • Traceability

Post Production

  • Non-Conformance Management
  • Incoming / Outgoing Inspection
  • Digital Clipboard