medac: Modernizing Quality Drives Business
Value and Reduces Cycle Times
“If we start a change control that affects different sites, we’re now able to start it in one process… and this allows us to shorten the approval time by three weeks.”
Global biopharma medac uses Veeva Quality Cloud to standardize quality processes across its sites. A unified approach has enhanced inspection readiness while increasing efficiency, resulting in a three-week reduction in the approval time for change control.
Previously each site operated differently, with some using manual, paper-based methods and others opting for hybrid systems. As a result, medac lacked a single view of quality operations for analysis and reporting. The team needed a consistent global approach to achieve its goals: increase FDA compliance, enable proactive quality, and standardize quality globally.
From disconnected processes to one platform
medac implemented Veeva QMS, QualityDocs, and Training to create a modern and connected system for sites and partners. By increasing visibility across the company’s manufacturing network and simplifying key processes, it has reduced the approval time for change control by three weeks.
Improving inspection readiness
Bringing together QualityDocs, QMS, and Training means all quality documents, training assignments, and training records are now centralized in a secure lifecycle. Training assignments are triggered directly from the CAPA within the system and once training is complete, the CAPA closes automatically, creating a clear audit trail for inspection readiness.
Moving toward proactive quality
Access to structured and standardized data on one platform supports good decision-making. medac is now able to use metadata to monitor trends before they turn into events. It also keeps track of system KPIs to improve quality processes and minimize risk.
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