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Intercell selects Q-Pulse as QMS solution after successful auditDiseases such as heart disease, infectious diseases and cancer threaten the lives of billions worldwide, and every year millions more are exposed to life-threatening diseases for which there is no effective treatment. Maintaining and improving quality is vital in designing and developing effective vaccines, and in managing their quality management system (QMS), Vienna-based Intercell has chosen a solution from Scottish software developers Gael Ltd. Intercell develops vaccines for the prevention and treatment of infectious diseases. Q-Pulse can help biotechnology companies to comply with regulatory requirements as well as to identify opportunities for continual improvement, from tracking corrective and preventive actions to measuring QMS effectiveness. As a biotechnology company with international activities, Intercell had to make sure that the solution they chose complied with regulatory requirements such as Annex 11 of the EU-GMP Guide, GAMP 4 and 21 CFR Part 11. Following a successful audit of the software in June, Intercell chose Q-Pulse as their QMS solution. ‘Q-Pulse has given us a structured framework for all of our document control activities and actions,’ says Fraser Leslie, Head of Quality Operations at Intercell’s Scottish manufacturing plant. ‘We’ve also been able to increase traceability throughout the change control process, as well as to speed up the turnaround for document change. ‘In addition, controlling our documents with Q-Pulse has helped us to cut down on the duplication of effort as well as to reduce paperwork at every stage of the process, which has also helped to reduce the time, effort and cost needed to maintain our documents.’ For further information please contact: |