Aerogen Pharma has modernised its quality document control framework by deploying Policy Express, a SharePoint-based policy and document management solution developed by Microsoft Solutions Partner Information EXP. The initiative reflects the company’s commitment to modernising compliance practices as it scales its inhaled therapies portfolio.
Managing regulatory requirements across Ireland and the United States, Aerogen sought a solution that could enhance audit readiness, support collaborative working, and embed continuous improvement, without the complexity typically associated with enterprise electronic QMS platforms.
“Like many small pharma companies, we were stuck with paper-based systems and wet signatures. Enterprise tools were out of reach,” said Dan Burgess, Senior Director of Quality Assurance. “When we discovered Policy Express, it was clear this would meet our needs without compromise.”
Within just 90 days, Aerogen Pharma fully deployed and validated Policy Express as an electronic QMS platform within its existing Microsoft 365 environment. Built entirely within SharePoint, the solution delivered:
- Full rollout in under 90 days
- 100% training compliance within 2 months
- Improved audit readiness and document control
- Significant cost savings vs traditional eQMS platforms
Unlike standalone platforms, Policy Express enabled Aerogen to extend its existing SharePoint environment. Teams can collaborate directly on procedures, track actions in real time, and maintain detailed audit trails that meet both EU and US compliance requirements.
“We now have a digital system that’s not only inspection-ready but has helped our team think differently about what’s possible in SharePoint,” Burgess added.
Policy Express continues to enable life sciences and other regulated industries to transition from manual, paper-heavy processes to modern, compliant digital systems, all without restrictive contracts or escalating licence fees.
