Medical Devices
An ISO 13485 certified medical device company cut CAPA cycle time by 64% and eliminated design review bottlenecks.
The Challenge
A mid-size medical device company with over 120 engineers designed and manufactured Class II and III devices under ISO 13485. Their design control and CAPA processes relied on SharePoint document libraries and Excel trackers — a setup that was creating serious bottlenecks.
Design controls in SharePoint + Excel
Design history files were scattered across SharePoint folders and Excel trackers. Finding the right version of a document for a design review required hours of searching and cross-referencing.
90-day CAPA cycle time
Corrective and Preventive Actions averaged 90 days to close, far above the industry benchmark. Root cause: lack of visibility, manual handoffs between teams, and no automated reminders.
5-day design review preparation
Each design review required 5 days of document hunting. Engineers spent more time assembling review packages than doing actual engineering work.
No real-time portfolio visibility
Leadership had no single view of project portfolio health. Status updates were compiled manually in monthly slide decks that were outdated by the time they were presented.
The Solution
The company migrated to ProBeya for design history file management, CAPA tracking, and project portfolio oversight. The transition was completed in 4 weeks, including data migration from SharePoint and Excel.
Linked design history
All design inputs, outputs, reviews, and verifications linked in a single traceable structure. Click from a requirement to its test result in seconds, not hours.
Structured CAPA workflow
CAPA lifecycle managed with mandatory fields, automated assignments, escalation rules, and effectiveness verification. No more lost CAPAs or forgotten follow-ups.
Always-on audit trail
Every document change, review decision, and CAPA update recorded with full attribution. Regulatory submissions assembled in minutes from live data, not reconstructed from archives.
Portfolio dashboards
Real-time project portfolio view with stage-gate tracking, resource utilization, and risk heat maps. Leadership sees current status, not last month's snapshot.
The Results
Within the first quarter, the company saw dramatic improvements in CAPA closure rates, design review efficiency, and project delivery predictability.
| Metric | Before | After | Change |
|---|---|---|---|
| CAPA cycle time | 90 days | 32 days | -64% |
| Design review preparation | 5 days | 4 hours | -97% |
| On-time project delivery | 55% | 88% | +60% |
| Regulatory submission readiness | Weeks of preparation | Always audit-ready | Continuous |
“Our design reviews used to be a nightmare of document hunting. Now everything is linked, traceable, and always up to date.”
Up from 55% before ProBeya. Real-time portfolio visibility and structured workflows eliminated the surprises that used to derail delivery timelines.
Streamline Your Design Controls
See how ProBeya manages design history files, CAPA workflows, and project portfolios with pre-loaded medical device demo data.