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Nanosonics selects Objective enterprise content management solution

  • 16 October, 2007 10:22

<p>Date: 16 October 2007</p>
<p>Objective Corporation (ASX: OCL), a leading provider of Enterprise Content Management (ECM) software, today announced that Nanosonics Limited has selected Objective to provide an enterprise content management solution to enhance their quality control by improving the information management.</p>
<p>Nanosonics, an Australian Life Sciences company, is focused on the research, development, and commercialisation of innovative technologies in infection control and decontamination. This involves delivering safe, non-toxic, rapid infection control and decontamination products.</p>
<p>Objective will replace Nanosonics existing system to provide a single corporate repository for business critical information. Without the Objective implementation, the existing system might increase the risk of non-compliance as volumes and product lines increase in the future.</p>
<p>As a result of a competitive tender, Objective was selected as the preferred supplier of a Document Control and Quality Management system. The Objective solution will provide a single point of access for all users from a diverse range of disciplines including engineering, marketing and quality management.</p>
<p>Mr John Murtagh General Manager – Business Systems and Regulatory Affairs, Nanosonics said: “We need a solution that is cost effective and one that lowers the non-compliance risk of managing the documentation associated with EN ISO13485:2003.</p>
<p>“It is essential that the solution scale to the requirements of a global company. Objective is the most suitable solution in meeting our complete requirements and future needs.”</p>
<p>Objective will support product development, manufacturing, financial and regulatory processes while providing electronic signatures, audit trail and document management for the subsequent records.</p>
<p>The solution will manage Device Master Records (DMR) - all of the routine documentation required to manufacture devices that will consistently meet company and regulatory requirements.</p>
<p>In manufacturing, quality management, business processes and product configuration carry strict levels of compliance and require efficient review and approval systems.</p>
<p>Nanosonics will use Objective to manage the configuration of medical devices throughout the manufacturing process. For instance, each product has its own DMR file which contains folders of manufacturing part numbers for product components. This is configured in a hierarchy enabling reviewers to understand product components at various stages in the manufacturing process.</p>
<p>“We will be able to track regulatory compliance and the status of any component at each level of the hierarchy. For example, we can examine whether products in production are compliant with the RoHS and WEEE regulations.</p>
<p>“Objective’s intuitive technology will automatically keep details of changes between design and production stages. It will update privileges for review and approval processes when changes are made to DMR records in design, and subsequently switched over to production”, said Mr Murtagh.</p>
<p>Objective will support compliance with the following regulations for electronic records, audit trails and signatures FDA 21CFR11; FDA 21CFR820; EN ISO13485:2003.</p>
<p>“The Objective solution provides Nanosonics with a cost effective regulatory compliant electronic document and quality management system, with the flexibility to add quality processes as the need arises”, said Mr Murtagh.</p>
<p>Contact Information
Objective Corporation Limited
Ph: +61 2 9955 2288
Fax: +61 2 9955 5011

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