Norwegian-based developer and manufacturer of short-lived radiopharmaceuticals, Norsk medisinsk syklotronsenter AS, has selected the electronic quality management system (EQMS), X-Docs, by Formpipe Life Science in a bid to drive operational efficiencies and safeguard compliance.

Meeting all key criteria specified in the URS, as well as exceeding expectations during initial demonstrations, phase one of the implementation has recently begun and is expected to deliver a range of benefits once fully operational in early 2018. Enhanced visibility over data and actions, and clear and accessible audit trails will come as standard post go-live, with the existing manual, paper-based system replaced by intuitive software that will streamline a range of processes, from change controls to management of training records and SOPs.

Currently experiencing significant growth, Syklotronsenteret recognised the need to bolster its methods of managing vital processes and procedures in order to safeguard compliance and futureproof the organisation as Ørjan Apeland, QP, QPPV and QA officer at Syklotronsenteret explains: “As a relatively small organisation, we have previously successfully relied upon a manual, paper-based system that has sometimes involved documents being driven between sites for signatures. As part of our growth strategy, we needed to mitigate any risk of compliance failure and we also needed to make sure we were in a strong position to sustain our growth long-term. EQMS was an obvious solution for Syklotronsenteret, and one that offered a number of benefits relating to better visibility of actions and data, more efficient and flexible working and – crucially – stronger compliance management. Automated data analysis and reporting was also an incredibly appealing feature.

“We selected X-Docs because, after reviewing other products on the market, we felt the solution from Formpipe Life Science was the best fit for our business, as it was as close to a pre-configured solution as possible, while also able to easily accommodate some of our unique requirements.”

Due to the web-based nature of X-Docs, the platform will be accessible remotely and will facilitate more flexible working practices for the 30 strong organisation. Hosted by Formpipe Life Science’s fully qualified datacenter, investment in IT infrastructure and validation effort will also be kept to a minimum as Ben Saxton, head of Europe sales at Formpipe Life Science confirms: “Syklotronsenteret is an impressive organisation at the cutting edge of short-lived radiopharmaceuticals for use in PET scans and, due to rising demand for its expert services, required a more robust, future-proof approach to its quality and compliance management.

“X-Docs was the clear choice for Syklotronsenteret – offering the closest thing to an off-the-shelf EQMS solution, whilst at the same time providing options for bespoke features to meet very specific needs. The system will grow with the business and deliver insight via reporting, tracking and tracing functionality that will be used to assess how Syklotronsenteret can become more efficient and make informed operational decisions based on its quality metrics. This in turn will put Syklotronsenteret in a very strong position for continued market success. We’re thrilled to welcome Syklotronsenteret as our first Norwegian X-Docs customer and look forward to delivering a clear return on investment for the organisation.”

For more information, or to request a demo, please contact Steve Griffith at steve.griffith@formpipe.com in the US or Ben Saxton at ben.saxton@formpipe.com in Europe.