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Aerogen Pharma has modernised its quality documentation processes by implementing Policy Express, a SharePoint-native policy and document control solution from Microsoft Solutions Partner Information EXP. The move supports the company’s continued growth in the biopharmaceutical sector, with a particular focus on inhaled therapies.
Operating within strict regulatory frameworks in Ireland and the United States, Aerogen required a compliant and scalable system that would enhance audit readiness, encourage collaboration, and reinforce continuous improvement, without the expense 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.”
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
By building on SharePoint rather than introducing a separate platform, Aerogen enabled teams to collaborate directly on SOPs, record every quality action within the system, and maintain a comprehensive audit trail that satisfies both EU and US regulatory 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 support life sciences organisations and other regulated industries in replacing manual, paper-based processes with modern, inspection-ready systems that avoid vendor lock-in and escalating licence costs.
