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Quality and Compliance
 

An Enterprise Approach to Quality Management and Compliance can Lower Both Cost and Risk

Establishing a quality process is one thing. Repeating that process thousands of times a day across multiple plants by employees speaking different languages is another matter entirely. Yet this type of consistency is the cornerstone to achieving regulatory compliance for your enterprise, including the establishment of complete product traceability to support future root cause analysis. Apriso’s customers are exemplifying their success in managing quality and compliance with the complexity of global operations. One Tier 1 automotive manufacturer has progressed their metric measurement from PPM (Parts per Million) to PPB (Parts per Billion) as how they now measure their Six Sigma defect rates. Another automotive manufacturer has reduced their product defect rate by 20%; another measured their payback of implementing Apriso in weeks, all from savings captured with quality containment.

Apriso solutions enable global companies to achieve new levels of control and compliance throughout far-flung manufacturing facilities. Apriso functions as an enterprise quality management solution that unifies plant operations, executing quality plans consistently across all facilities to enable detailed product genealogy and interlocking traceability of product and process. At any given step, Apriso can halt production or inventory and contain out-of-spec materials should a quality nonconformance event occur. You can establish repeatable processes, test their effectiveness, and then deploy them throughout your organization. And, as regulations change, Apriso makes it possible to easily perform updates to your processes without necessarily involving your IT team, ensuring you remain in compliance while still being able to continuously improve your processes.

Apriso enables enterprise quality management and regulatory compliance by:

  • Maintaining consistent execution of processes, both from within a particular location and across the enterprise
  • Supporting regulatory compliance such as 21-CFR Part 11 and Part 820, ISO-14002, ISO-9001-2000 and others; see more here
  • Providing a platform for global deployment and management of business processes and best practices through Apriso Global Manufacturing Suite
  • Incorporating a unified quality planning and execution solution as a seamless part of the user experience, eliminating human error
  • Supporting in-line SPC for automated quality validation and alerts on based on unfavorable trending or out-of-tolerance conditions
  • Integrating with product and process development, supporting scale-up and manufacturing validation, helping to ensure products meet design and customer specifications through new product introduction, while ensuring compliance with corporate quality systems
  • Tracking in detail when process changes are performed, including who authorized the changes
  • Providing comprehensive product traceability, tracking and reporting to meet global compliance and reporting requirements