Vivacta achieves ISO13485 for quality management
31 January 2009
Vivacta has announced that it has achieved compliance with ISO13485,
an important step towards the successful commercialisation of its
ultrasensitive point-of-care immunochemistry system.
This clears the way for the company to partner with larger in vitro
diagnostic companies, which place major demands on compliance with
global regulatory requirements.
Vivacta’s Director of Quality, Sonja Johnston, said, "Following 18
months of quality system development, the company now has a very robust
system, designed around our processes and operating procedures. This was
confirmed in the audit carried out by LRQA, as it revealed no major, or
minor, non-conformities.”
Johnston added, “Vivacta decided very early in the development of its
quality management system to adopt modern processes, including
electronic document control, even though these brought with them issues
with regard to the use of appropriately validated systems. This is
particularly relevant for the US market, where Part 11 compliance is
required.”
By adopting a system that embraces these requirements, Vivacta now
has a documentation system that is readily accessible by all employees
using computers in their working environment.
Neil Butler, CEO Vivacta, added, “As the establishment of fruitful
partnerships with the larger diagnostics companies is key to our
long-term development, it was essential that we could meet all the
demands with respect to quality compliance.”
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