MountainStar Blood Services take control of documentation for 21 CFR Part 11 compliance
With the network’s blood-dependent services, which include emergency surgeries, needing more than 2000 units of blood a month, when MountainStar needed a solution that would enable them to maintain regulatory compliance, they chose Q-Pulse from Ideagen.
Q-Pulse can help blood service providers like MountainStar Blood Services maintain and improve regulatory compliance, as well as streamline processes and reduce the duplication of effort by enabling the integration of compliance activities and actions.
- Risk of data duplication reduced and security of information – including patient data – increased
- Visibility of workload including where documents are being reviewed, who is revising and, once finalised, who is approving
- Detailed audit trail & electronic records management allows technical controls of 21 CFR Part 11 to be put in place
- All supplier current and historical data is stored in the system meaning they can be assessed prior to inspection MountainStar Blood Services take control of regulatory activities in a single integrated system
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As in every industry, there are so many aspects of blood banking that require control, and Q-Pulse more than meets our needs, as it allows us to control many of our regulated activities with a single integrated system.