Global
France
Germany
JapanPharmaceutical & Life Sciences
Achieve compliant management of all electronic records and documents
Customer Feature
“Compliance is a critical part of our business as is any company under these regulations. Failure to comply could result in financial loss due to penalties, possible recall,or worse, criminal penalties. We need to ensure we have access to and the most recent versions of business critical documents such as Standard Operating Procedures (SOPs) for our Manufacturing, Quality, and any operation that has an effect on our products. This includes the IT systems that support these functions."
Mark Wescott, Genzyme’s Senior IT Manager, ECM, Genzyme
Open Text ECM applications for Life Sciences are designed to address the complete lifecycle of all content within a pharmaceutical, biotechnology or medical device manufacturing company. Open Text’s strength in life sciences is their ability to deliver best-of-breed vertical market solutions which provide 21 CFR Part 11 compliance on one of the top Enterprise Content Management suites in the market.
Open Text ECM applications for Life Sciences provides product flexibility, which in turn allows customers to address multiple business processes through configuration – rather than programming – and does not restrict the use of the system to a predefined set of interfaces, templates, appearances and processes. Organizations can address many business process challenges using Open Text technology. Some of these processes include SOP management, regulatory submissions management, CAPA management and product development lifecycle. In addition, life sciences companies can leverage Open Text’s market leading solutions for contracts management, eDiscovery, ERP data and document archiving, accounts payable, web content management and digital asset management.
Open Text ECM Applications for Pharmaceutical & Life Sciences
Open Text ECM applications for Pharmaceutical & Life Sciences include:
Open Text Regulated Documents is a complete solution to securely manage key documents throughout a controlled lifecycle in compliance with relevant regulatory requirements.
Open Text Quality Management is a complete solution for businesses operating in highly regulated industries that helps to ensure quality regulatory compliance in their products and services.
Open Text Regulated Documents for Microsoft SharePoint takes advantage of the collaboration features in SharePoint, such as the document information panel, Windows Workflow Foundation, InfoPath Forms and content management capabilities and thus significantly improves end-user experience and enhances productivity.
Open Text Clinicals is designed to manage the capture and review of all trial-related information throughout the setup, conduct and review of clinical trials.
Open Text Collaborative Submissions is a comprehensive, collaborative environment for the authoring, review, approval, assembly, export, and long-term management of all regulatory documents and submissions.
