Life Sciences Get Objective
Life Sciences Get Objective
October 17, 2007: Life Sciences company, Nanosonics Limited has selected an Objective solution for ECM, that will improve the flow of information management and enhance the quality of products.
Delivering a number of safe, non-toxic and rapid infection control and decontamination products, Nanosonics researches and develops a number of innovative technologies around infection control and decontamination.
Objective says by providing Nanosonics with a single corporate repository for business critical information, they can assist Nanosonics in decreasing the risk of non-compliance as volumes and product lines increase in the future.
Objective will provide a single point of access for a diverse range of users and support product development, manufacturing, financial and regulatory process while also meeting security and document management needs.
John Murtagh, general manager of Business Systems and Regulatory Affairs at Nanosonics says they were after a cost effective solution to lower this non-compliance risk. “It is essential that the solution scale to the requirements of a global company,” he says.
“Objective is the most suitable solution in meeting our complete requirements and future needs.”
Nanosonics will also use the ECM solution to manage the configuration of medical devices throughout the manufacturing process while also allowing it to manage Device Master Records (DMR) – routine documentation required to manufacture devices. The DMR file would contain folders of manufacturing part numbers for product components and be configured in a hierarchy to enable reviewers to see all aspects of the manufacturing process.
”We will be able to track regulatory compliance and the status of any component at each level of the hierarchy,” says Murtagh. “Objective’s intuitive technology will automatically keep details of changes between design 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.