Aerogen Pharma, an expanding biopharmaceutical business focused on inhaled drug delivery, has overhauled its approach to quality documentation by adopting Policy Express, a SharePoint-native policy and document control solution created by Microsoft Solutions Partner Information EXP.
Operating within tightly regulated frameworks in both Ireland and the United States, the company required a modern system capable of strengthening audit preparedness, enabling better collaboration, and reinforcing continuous improvement, all while avoiding the cost and complexity of 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.”
- 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
By leveraging SharePoint rather than introducing a separate system, Aerogen enabled teams to collaborate in real time on SOPs, maintain comprehensive audit trails, and track all quality-related actions in one secure environment, fully aligned with both EU and US regulatory expectations.
“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 support life sciences organisations and other regulated sectors in moving away from manual, paper-driven processes, delivering inspection-ready digital systems without restrictive vendor lock-in or escalating licence costs.
