Case Study: Blood Bank of Alaska achieves state‑wide 21 CFR Part 11 compliant document management with Ideagen (Q‑Pulse)

Blood Bank of Alaska: achieving state-wide 21 CFR Part 11 compliant document management

Blood Bank of Alaska, based in Anchorage and serving more than 20 hospitals across the state from six fixed sites and mobile crews, needed a cost-effective, user-friendly way to provide secure, up-to-date controlled documents at the point of need. The organisation had to meet strict FDA, AABB and CLIA requirements—including 21 CFR Part 11—and required centralized document access, site-level change requests and consistent revision distribution across a geographically dispersed workforce.

The bank implemented Q-Pulse from Ideagen, integrating it with existing systems to provide centralized document control, electronic signatures, full audit trails and streamlined change-control workflows. The result was faster, cheaper management of quality information, improved accuracy of documents and patient records, reduced time spent on change control, and technical controls that support 21 CFR Part 11 compliance and easier regulatory inspections.

Blood Bank of Alaska

Marilyn Jeffers

Project Manager for Quality Assurance