Identifying documents impacted by a proposed change order can be opaque and rife with human error. The risk of missing the impact of change is costly and introduces increased risk.
Mitigate the risk of missing documents impacted by a change order while creating significant efficiencies that help balance speed, quality, and costs across the change process.
Collaborate and track design reviews with Part 11 compliant workflows.
Collaborate and track design reviews with Part 11 compliant workflows.
Bring together cross-functional information to provide seamless visibility and traceability throughout the change management process, instead of manually sorting through files from different teams.
Bring together cross-functional information to provide seamless visibility and traceability throughout the change management process, instead of manually sorting through files from different teams.
Analyze and give feedback on change recommendations. Approve or reject change and collaborate with your teams on next steps.
Analyze and give feedback on change recommendations. Approve or reject change and collaborate with your teams on next steps.
Receive a curated list of recommended documents, artifacts, and quality events to assess the impact of a change and add to your change order.
Receive a curated list of recommended documents, artifacts, and quality events to assess the impact of a change and add to your change order.
AI-powered recommendations that mitigate risk
AI-Powered Recommendations that improve quality.
AI-Powered Recommendations that empower people and processes.
Eliminate the manual effort of linking and reviewing documents impacted by a change. Easily digest the information in your quality system to make positive, sound quality decisions that lead to better patient outcomes and overall success for your company.
It’s important to get a change right — the first time. Simplify your change management process with recommendations that reduce the risk of human error and avoid rework in making an update or executing a change. Work proactively by knowing what’s downstream and which actions to take.