Regulatory Document Management
Services
Document Management, Business Process Management, User Experience
Situation
The company develops and markets a method for treating benign prostate enlargement without the need for surgery. Like all medical technology companies operating on the US market, the company has to comply with the US Food and Drug Administration’s (FDA) regulations for the management and archiving of documentation. The FDA has very stringent demands on secure archiving to ensure documentation cannot be changed or manipulated once it is stored. “Our paper documentation system also complied with FDA requirements of course but we were slowly drowning in paper and needed to find a solution,” says the manager responsible for Quality Assurance from the research and development department. “When we were in the market for a suitable document management system we discovered that some systems could not be configured for our processes and be approved by the FDA and others were much too large and expensive for a small company like ours. We may be small now but we intend to grow, so we needed a document management system for both present and future needs".
Action
advantum suited the company perfectly. Not only is it a standardised and flexible system that can be configured when needs arise, it also includes a solution tailored to the Life Science business area and can be configured into a complete PLM system if required. As a consequence a complete document management system was configured to encapsulate the whole business process of the company combined with all of the necessary controls to fulfil the requirements of the FDA.
Results
“We have now completed the first two phases of the implementation, which will guarantee secure archiving and management of our documentation and the workflow introduced electronic signatures. We can now look forward to a drastic reduction in time spent on finding documents and a decrease in the use of paper,” concludes the QA manager.
Technology
advantum
