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Advanced Oncotherapy uses PLM to Achieve and Sustain ISO Compliance and FDA Validation

Advanced Oncotherapy uses PLM to Achieve and Sustain ISO Compliance and FDA Validation

Customer challenge

Advanced Oncotherapy had the following business challenges identified such as cost was an issue as they were developing many of our business processes from scratch. Next was they wanted a platform to enable them to control the business without mounds of paperwork. In addition to that, their goal was to expand beyond the traditional PLM functionality of managing the product, and include other areas such as quality and non-conformity. Initially, the team looked at expanding the use of their previous PLM system as it contained some of the functionality required, but it came at an extra cost.

Project goals

The customer's primary goal was to develop processes to support their highly-educated and talented workforce with a minimum of paperwork and manual intervention. As a premier designer and manufacturer of medical devices, Advanced Oncotherapy will be subject to regulatory compliance. The company recognized the importance of a fully integrated business system to support its operations and meet the upcoming requirements of regulatory bodies.

Solution

Autodesk Fusion Manage was the best product lifecycle management solution as you can access all its capabilities for a single license fee. Advanced Oncotherapy commenced its implementation in late Spring. Within 3 months they had transferred all of the data and went live with the basic components. Symetri provided the training and support and helped to improve their understanding of Autodesk Fusion Manage and ultimately refine their processes. Previously, Advanced Oncotherapy only had six users on its legacy PLM system. By taking advantage of the additional capabilities available in Fusion Manage, the company expects that everyone in the organization will eventually have access to the system.

Business outcome

Now, the company has a one-stop-shop for evidence of business processes and reporting. The team is currently using Autodesk Fusion Manage for Audit Management, Goods Receiving, Customer Complaints, Change Control, and Intellectual Property Management, and are working towards complete integration of PDM, PLM, and ERP activities to minimize administrative work and reduce risk of errors. Long term objective: All master data and ‘objects’ in one place for ease of audit.

Conclusion

Advanced Oncotherapy continues to be delighted with Autodesk Fusion Manage and has renewed its software license. Symetri continues to work closely with the company in expanding the product capabilities. “The medical industry is exceptionally risk-averse. One of the main reasons we’re using Fusion Manage is to reduce risk – in terms of our product, and in terms of the ultimate result of the treatment of patients.” - Neil Barker, Quality and Process Improvement Manager

Project summary

    Duration & delivery

  • 365
  • 2022-01-03

    Autodesk solutions

  • Fusion 360 Manage
  • Vault Professional
  • Fusion Lifecycle

    Services provided

  • Product Training
  • Technical Support
  • Solution Adoption Services
  • System Implementation
  • Configuration & Deployment
  • Business Process Assessment & Documentation
  • Data Migration

    Customer industry

  • Design
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