Learn how Advanced Oncotherapy is using PLM to achieve and sustain ISO compliance and FDA validation
Advanced Oncotherapy has one focus: to defeat cancer and save lives. To achieve this, they are focused on developing technologies that will maximise the destructive effect on cancerous tumors, while minimising the damage to healthy tissues. They are currently leading the new wave of proton therapy treatment by developing a smaller and significantly less expensive system than exists today. As Advanced Oncotherapy is working to bring this new technology to market, they are using Fusion Manage as their single source of truth for evidence of business processes and reporting.
As a company transitioning from research and development to manufacturing, Advanced Oncotherapy recognized the significance of efficient, defined business processes supported by integrated systems. Their 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. Advanced Oncotherapy recognized that manual systems and its existing PLM software would not allow the company to develop business processes that would achieve and sustain ISO compliance and FDA validation. Already a user of several Autodesk® software products, Advanced Oncotherapy added Fusion Manage as the tool to develop workflows and control business processes in every area of the organisation.
Although Advanced Oncotherapy is still manufacturing prototypes, the company recognised the importance of a fully integrated business system to support its operations and meet the upcoming requirements of regulatory bodies. However, the company soon realized that its legacy PLM system would be an impediment to achieving a fully integrated business system. “As a stand-alone PLM system managing our engineering change control process, our old PLM software worked fine,” said Neil Barker, Quality and Process Improvement Manager. “However, we realised that we needed to integrate data from our PDM, CAD, and eventually our ERP systems. With our old PLM software, this was not possible. As we were already using many other products from Autodesk including Inventor (3D CAD software), Vault (data management software), and A360 (project collaboration software), it made sense to evaluate Autodesk’s PLM software, Fusion Manage.”
Challenges
- Cost, they were developing many of our business processes from scratch.
- Wanted a platform to enable them to control the business without mounds of paperwork
- 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 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.
Solutions
- Fusion Manage was the best solution as you can access all its capabilities for a single license fee
- Advanced Oncotherapy commenced its implementation in late Spring, with the assistance of D2M3, a consulting firm and Autodesk partner. Within 3 months they had transferred all of the data and went live with the basic components.
- D2M3 provided the training and support and helped to improve their understanding of Fusion Manage and ultimately refine their processes. D2M3’s commitment to the project was excellent
- 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 organisation will eventually have access to the system.
Benefits
- One-stop shop for evidence of business processes and reporting
- Currently using Fusion Manage for Audit Management, Goods Receiving, Customer Complaints, Change Control, Intellectual Property Management
- 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
