\nGlobal biopharma medac uses ³Ô¹Ï±¬ÁÏ 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.\n<\/p>\n
\nPreviously 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.\n<\/p>\n
\nmedac implemented ³Ô¹Ï±¬ÁÏ QMS, QualityDocs, and Training to create a modern and connected system for sites and partners. By increasing visibility across the company\u2019s manufacturing network and simplifying key processes, it has reduced the approval time for change control by three weeks.\n<\/p>\n
\nBringing 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.\n<\/p>\n
\nAccess 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.\n<\/p>\n