A global pharma leader was facing challenges with its pharmacovigilance and regulatory reporting. With numerous aggregate reporting processes and tools, critical activities such as template management, report generation, and approvals were inconsistent, labor-intensive, and fragmented.  

Other essential operational features like version control, commenting, and report locking were missing, undermining collaboration and audit readiness. Overall system performance was another concern with large data volumes, causing frequent system crashes and delays, forcing teams to rely externally to complete complex reports.

Security and governance were also key worries as the current system lacked fine-grained access controls. Without a central source of reference data, reports often had inconsistent information. Additionally, there was no scalable way to handle ad hoc or recurring report requests, assign tasks to team members, or monitor progress. This made the entire reporting process inefficient and hard to manage.

As regulatory demands grew and data complexity increased, the existing setup became unsustainable prompting the need for a modern, integrated, and automated safety reporting solution that was scalable and efficient, supporting evolving business needs.