Aerogen Pharma has transformed its Quality Management System by implementing Policy Express, a document and policy management solution built natively on SharePoint by Microsoft Solutions Partner Information EXP. The move supports the company’s rapid growth in the biopharmaceutical sector, particularly within inhaled therapies.
With operations spanning Ireland and the US, Aerogen needed a compliant, reliable system that could simplify audits, encourage collaboration, and align with regulatory demands, without the financial and operational burden associated with traditional 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:
- Significant cost savings vs traditional eQMS platforms
- Full rollout in under 90 days
- 100% training compliance within 2 months
- Improved audit readiness and document control
Because the solution is embedded within SharePoint, teams can work directly with SOP authors, record every action automatically, and retain a clear, end-to-end audit trail. This approach ensures compliance with both European and US regulatory standards while improving day-to-day usability.
“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.
Today, Policy Express is helping regulated organisations modernise quality and compliance processes, replacing manual workflows with scalable, inspection-ready systems that avoid unnecessary licence costs and long-term vendor dependency.
