Test Specifications and Analytical Procedures

The Challenge

In order to ensure the quality of their products, life sciences companies must first ensure the quality of the raw materials and component parts used to manufacture their finished goods. This process involves the development of test specifications, which define the tests to be performed and criteria to be achieved, and analytical procedures or test methods, which define how each test should be performed.

The management of test specifications and analytical procedures presents several business challenges. The data contained within test specifications must be made available to laboratory information management systems to drive automated testing activities. The analytical procedures must be validated to ensure that they are effective and achieve the desired results. Test specifications and analytical procedures must also be translated into multiple languages to support testing in various countries.

 Life sciences companies need effective procedures and systems to ensure that test specifications and analytical procedures are efficiently managed through a complete lifecycle that includes content re-use and translation to multiple languages.

The Glemser Solution

xmContent® is a scalable, XML-based application framework built on top of the EMC Documentum® content management system that can be configured to effectively manage test specifications, analytical procedures and related documents, such as validation reports and document histories. xmContent manages documents at the fragment level. Individual fragments can be linked to multiple documents, so redundant content can be defined once and used in multiple parent documents.

xmContent provides an intuitive, user-friendly interface for managing documents in XML format. All XML-based content is authored in MS Word using Quark’s XML Author® editor. These XML documents can be
automatically rendered to HTML, PDF and MS Word formats for a variety of business purposes, such as supporting on- and off-line review and approval processes, distributing documents via web sites, etc.

xmContent also provides a comprehensive set of document management functionality for managing templates, locating documents through property-based searches or through their relationships with other documents, working with content fragments, creating and managing translations, and automating document
review and approval processes using a configurable workflow facility. xmContent also supports web service access to XML content stored in the repository for seamless integration with laboratory information management systems.

For more information, download Specification Management solution data sheet.