Two blood service providers in the US Blood Bank of Alaska and Utah-based Mountainstar Blood Services required a central Quality Management System (QMS) to help manage their organizations’ processes and procedures to comply with strict FDA regulations.
Q-Pulse from Scottish software company Gael Ltd, provided the solution. Developed to support the operational activities of an organization’s compliance management system, Q-Pulse helps blood service providers comply with regulatory requirements such as JCAHO, AABB, FDA and ISO. From tracking corrective and preventive actions and keeping track of documentation, to measuring the effectiveness of the QMS, Q-Pulse is a market leader in compliance software for the healthcare sector.
Used by other US blood banks including Rhode Island Blood Bank, Community Blood Center of Kansas City and Heartland Blood Center, Q-Pulse supports the operational activities of a company’s compliance management system, including audit management and document control, obtaining real results that positively transform compliance.
With FDA oversight of blood centers and transfusion centers increasing, all Blood Banks must ensure the QMS solution they choose complies with rigorous FDA and AABB industry standards, for example 21 CFR parts 11, 210-211 and 600 – Q-Pulse provides this solution.
Margaret Baker of the Blood Bank of Alaska commented:-
‘Q-Pulse provides us with a centralized system that offers point-of-need access to our QMS documents and records, including all of our SOPs, which will improve the accuracy of our records and the version control of our documents. Putting Q-Pulse in place to help manage our regulatory compliance will also help us to streamline our processes, as well as to reduce the duplication of effort by enabling us to integrate our compliance activities and actions.’
As an FDA-licensed blood center, MountainStar Blood Services chose Q-Pulse as their QMS solution in managing compliance with strict FDA regulations.
‘What we wanted in a word was control,’ says Judy Francis, Technical Supervisor at MountainStar. ‘Now, with Q-Pulse, we can maintain control at the user level, with a central repository that reminds us when we’re due for review and updating of all of the components that make up regulations.
‘With Q-Pulse, controlling our SOPs, forms, etc. is very easy: we’ve included all forms, training records and competency tests, as well as pamphlets, donor cards and other documents that we hand out to our donors.’
Gael is exhibiting at the forthcoming AABB Annual Meeting & TXPO in Montreal on 4-7 October 2008, which will offer other blood service providers an opportunity to find out how Q-Pulse can help organisations comply with regulations including, AABB, JCAHO, FDA and ISO.
From implementing and maintaining processes and procedures, to improving and growing a company’s compliance management system, Q-Pulse is a market leading solution for Healthcare Quality Management. Contact us now to find out how Q-Pulse can improve efficiency and ensure regulatory compliance, or visit www.q-pulse.com for more information.
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Notes for Editors
Established since 1995, Gael Ltd is a market leader in the design, development and delivery of compliance management software. Having in excess of 100,000 users worldwide, the company’s flagship product, Q-Pulse, has consolidated its position as a market leader in the compliance management software marketplace providing a single central environment for Healthcare Quality Management.
Internationally, Gael operates a unique hybrid business model, combining the strengths of both channel and direct sales, to ensure that both its products and services are available across the globe.
The company operates a Q-Pulse business partner network: companies strategically chosen and professionally trained in Gael implementation methodology to provide the exceptional level of customer service, commitment and support Gael would provide, locally. Business partners from around the world, including North America, Middle East, Australia and across Europe, ensure Gael is well placed to offer international customers a level of service second to none.
Contact Details – Alan Hiddleston, Partner Manager, Gael Ltd, alanh@gaelquality.com,
T: +44 (0)1355 593400 F: +44 (0)1355 579191 E: info@gaelquality.com W: www.gaelquality.com
