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Blood Bank of Alaska achieve statewide 21 CFR Part 11 compliant document management

Blood Bank of Alaska achieve statewide 21 CFR Part 11 compliant document management

At more than twice the size of Texas, Alaska is the largest state in the US, but, with few road connections compared to the rest of the country, most cities and villages in the state – including the state capital, Juneau – are accessible only by sea or air.

With six different locations across the state of Alaska, as well as mobile crews, the Blood Bank needed a solution to access up-to-date, FDA-compliant copies of their controlled documents securely and at the point of need. With recent advances in medical and surgical care driving an increasing demand for blood and blood products, the Blood Bank had to expand its services while maintaining high levels of quality and safety throughout the transfusion process.

Q-Pulse provides blood operations like the Blood Bank of Alaska with a fully integrated compliance management solution that helps manage regulated activities including Document Control, Auditing, and CA/PA Management, in regulatory and compliance environments.

Benefits

  • Integration with existing systems eases roll-out and increases adoption of Q-Pulse
  • Huge savings in time, effort and costs in relation to management of information and quality data
  • Accuracy of documentation and patient records improved significantly, including automatic review notifications
  • Time associated with document change control process decreased
  • Electronic signature functionality – including intruder lock-out and password expiration – eases compliance with 21 CFR Part 11
  • Full audit trail in creating, editing and deleting records
  • Management of QMS documentation and patient records is now in line with FDA record keeping requirements

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We’ve made huge savings in time, effort and cost in terms of managing our information. Q-Pulse has also helped us to reduce the time and effort spent throughout the change control process...

Marilyn Jeffers, Project Manager for Quality Assurance
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