Diseases
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.'