Allows companies to launch enterprise-wide new product introductions on-time and on-budget.
ENOVIA Life Science Accelerator for Change Control
Quickly and accurately execute product changes by coordinating all stakeholders into the approval process to overcome organizational bottlenecks.
Change is constant. That’s why a best-in-class Change Control system is critical for promoting innovation and growth while maintaining a state of control. A Change Control system for document changes, design changes, production and process changes is at the heart of every Quality System and a crucial element of regulatory compliance.
The complex changes common today involve a myriad of elements – specifications, procedures, test methods – that must be carefully coordinated and verified throughout the change process. 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 to execute changes increase the likelihood of error. In fact, few companies have a “don’t ask, don’t tell” policy towards errors in their change process – that is, until an auditor starts asking difficult and probing questions.
ENOVIA Life Sciences Accelerator for Change Control is designed to help Life Science companies manage the change process from request to implementation and closure. It is intended to ensure that the proper processes are followed every time and that change activities are completed according to plan.
- ENOVIA Life Sciences Accelerator for Change Control enables organizations to bring industry-leading products to market more quickly and reliably by focusing on the creative aspects of design instead of administrative details.
- Product teams can easily collaborate with various contributors and stakeholders to plan changes, expedite documentation and deliver new products.
- ENOVIA Life Sciences Accelerator for Change Control enables organizations to respond more quickly to market opportunities by streamlining their change process.
- Complete changes on time and on budget by automating change execution. With the ENOVIA Life Sciences Accelerator for Change Control, customers find that the time to execute a change often shrinks by 15-45% and lost sales due to launch delays drop by 15-30%.
- ENOVIA Life Sciences Accelerator for Change Control improves the quality and consistency of document deliverables to dramatically reduce regulatory risk and avoid audit findings.
- Organizations can satisfy QSR/ISO regulatory requirements and achieve Six Sigma objectives through enhanced process control, metrics and real time reporting.
Change Documentation and Impact AssessmentsThe Quality Change Order is used to control the change to the affected documents from beginning to end. The Quality Change Order captures basic information such as the description and the reason for change. It guides users through the collection of required information such as risk assessments, regulatory assessments and cost analyses. ENOVIA Life Sciences Accelerator for Change Control provides dynamic links to related documents and data for improved visibility into related business processes. Summary, Aging and History Reports are provided to improve change status visibility and help identify process bottlenecks.
Implementation Action PlansThe Quality Change Order is used to capture a detailed Action Plan that to assess and, later, implement the required change. The Action Plan can require predetermined Action Tasks to be completed depending on the type of change or other defined criteria. Alternately, Action Tasks can manually be added as needed for that particular change. Until the specified action tasks are completed, the Quality Change Order is prohibited from proceeding to the next phase. Action Tasks are updated in the system directly by the person assigned to the task, thereby eliminating the burden of manually tracking Action Plan execution and providing activity traceability.
Process ApprovalsWhen approving a change, ENOVIA Life Sciences Accelerator for Change Control automatically determines the appropriate approvers depending on the types of documents being changed and other defined criteria. The approvals comply with the U.S. Food and Drug Administration’s (FDA) Part 11 regulation for access control, security and traceability.