Cantel Medical was formed through the merger of several companies but was without a PLM system or a QMS (quality management) system. The company reached out to Zero Wait-State to help implement a PLM system with a focus on quality management and issue management so that they could resolve quality problems by identifying, managing and tracking complaints tied to a case (issue) in their case management tool.
Using a cross-application approach, ZWS took a broader, holistic view of Cantel’s needs. ZWS loaded all parts and documents into Propel PLM and implemented change processes against these. In addition ZWS deployed issue and complaint management, and implemented a training management solution tied to training requirements when documents change in Propel PLM. Such electronic management is required for medical device companies to meet compliance and oversight obligations. In a second phase, ZWS deployed BOM and change management in Propel PLM and created a full integration between Propel PLM and SAP ERP.
Cantel can now achieve and maintain the regulatory compliance required in the medical device industry. The company electronically manages parts, documentation, BOMs, training records and more. With PLM’s single version of the truth about the product, countless spreadsheets were replaced, costly errors are minimized, issue management is expedited and compliance is maintained.
Fresenius Medical was a long-time Agile PLM user, but the company managed all its material compliance data outside the PLM system with a completely manual approach. This manual material compliance process didn’t scale well, hindering the company’s rapid growth and forcing it to look into hiring additional staff solely for the administrative task of tracking the data. Fresenius was reluctant to invest money in another Agile module when Oracle considers Agile PLM to be end of life.
Zero Wait-State implemented a complete compliance management solution in Agile PLM using the PLM system-agnostic roll-up engine extension to AttributeState. This solution currently provides support for RoHS, REACH, Prop 65 and CMR/CLP. ZWS also created an integration between the compliance solution in Agile PLM and Total Parts Plus (a Parts Data Content Provider) to automatically pull compliance information from manufacturers for their parts into the PLM system and roll up the compliance states throughout AMLs and BOMs by revision. Change processes check parts for compliance and warn about or block the release of changes that will result in a regression of compliance.
A small Fresenius staff now handles the compliance requirements for all Fresenius’ parts and products. Data collection is fully automated and manual processes are no longer a roadblock. The improved system is scalable no matter how Fresenius grows. In turn, Fresenius staff have been freed to perform higher level quality assessments and surveys.