Many life sciences organisations carry years of accumulated validation documentation – a combination of paper-based processes, hybrid approaches, and disconnected digital systems. The result is that validation evidence, requirements, testing records, approvals, and change documentation are fragmented across repositories that have no connection to the Quality Management System.
This fragmented landscape creates real compliance risk. Demonstrating complete traceability across a validation lifecycle is difficult when the data is spread across silos. Inspection responses take longer. Remediation efforts are inefficient. And the disconnect between Quality, IT, Validation, and Business functions limits transparency and slows decisions.
A data-centric validation approach addresses these challenges directly – establishing a single source of truth that connects validation activities, risks, testing, deviations, approvals, and changes across the full system lifecycle.
UCB presented its evolution toward a data-centric validation model. The presentation highlighted the importance of connecting validation evidence, requirements, testing, risk assessments, deviations, approvals, and change records within a single digital framework, replacing fragmented document repositories with an integrated and traceable data model.
Among attendees, there was broad recognition that the transition to data-centric validation is becoming a business and compliance imperative. However, organisations also acknowledged that success depends not only on implementing new platforms and processes, but on establishing a pragmatic approach to managing and migrating decades of legacy validation documentation.
