Regulatory managed services for a global eQMS estate — quality-event backlog cleared, KPI compliance restored to green

Pain points before the engagement

• Quality-event backlog was growing month-over-month and had breached leadership visibility thresholds
• The internal quality team was firefighting the backlog instead of improving the system
• KPIs on event closure time and CAPA effectiveness were in the red across three sites
• Regulatory reviewers had flagged the trend at the last inspection — the team was on notice
• No consistent dashboard existed across the eQMS estate — reports were assembled monthly by hand

Problem

The pharma operations function had grown through acquisition and inherited three eQMS deployments that were nominally the same product but operationally different. Quality events were opened faster than they could be closed. CAPA effectiveness was patchy. The last inspection had flagged the trend, and leadership wanted a partner that could own the outcome — not just add more contractors to the backlog. Cybroscape's brief was to take over managed operations of the eQMS estate and deliver KPI compliance back to green within two quarters.

Approach

We took over eQMS managed operations on a defined SLA. The backlog was triaged first — every open event categorised, prioritised and given an owner. Dashboards went up so leadership had visibility without a monthly PowerPoint. Incident-response protocols kept SLA-critical events from ever entering the backlog again. CAPA effectiveness was tightened with a real effectiveness check requirement, not just a closure signature. Continuous-improvement work took over from firefighting once the backlog was clear.