The complex changes management processes involve a myriad of elements – specifications, procedures, test methods – that must be carefully coordinated and verified throughout the change process. Life sciences companies must adequately assess and validate the impact of changes, but are hamstrung by poor assessment methods, complex procedures and inadequate approvals. Moreover, manual steps in executing changes increase the likelihood of error.
Dassault Systemes (DS)’ change management solution provides medical device companies the ability to effectively manage the change process from request to implementation and closure while ensuring the proper process is followed every time and change activities are completed according to plan. DS solution manages changes to all quality system documents, procedures and specifications throughout an organization with previously unattainable levels of automation and control. It provides a single, flexible electronic change process to improve operational efficiency and enforce procedures to minimize compliance risk.
A change order captures the important information about a change such as the description and reason for change, in addition to a collection of detailed information such as risk assessments, regulatory assessments and cost analyses. Our solution provides dynamic links to documents and data for enhanced interaction with other business processes such as the CAPA process, the supplier control process, and the product development process. It also provides standard summary, aging and history reports to improve visibility into the status of changes and helps identify bottlenecks in the process.
We adhere to the MDD Europe and the FDA for the USA. With DS PLM system we can handle the process much more effectively and ensure we don’t miss anything.
Claes-Göran Andersson Project Manager, Mölnlycke Health Care