Helping you achieve compliant management of all electronic records and documents

Pharmaceutical and life sciences companies operate in a highly regulated environment with long product lifecycles. Their operations are both data and document-intensive. Pharmaceutical product development can take up to 15 years and $1 billion or more per product. Recent demands for increased public accountability against a trend of fewer new products and expiring patents are threatening traditional profitability and revenue growth.

As an example, Pharmaceutical organisations use a variety of applications, databases and spreadsheets to record and track Corrective and Preventive Actions (CAPA) and complaints. These applications are often manual and do not provide tools for automating the required actions associated with CAPA and complaints management. Some examples include failure analysis, trend tracking or corrective action tracking.

Existing applications are often inadequate for maintaining the thorough and timely performance of quality objectives that require manual actions. Furthermore, Therapeutic Goods Administration (TGA), U.S. Food and Drug Administration (FDA) and ISO requirements are continually changing and expanding, particularly in the areas of electronic signatures and electronic records.

Knowledge Partners offers information management solutions to the Pharmaceutical and Life Sciences industry through the OpenText ECM Suite.  The OpenText ECM applications for Life Sciences modules are designed to address the complete lifecycle of all content within a pharmaceutical, biotechnology or medical device manufacturing company.

Our solutions delivered through OpenText for the Pharmaceutical and Life Sciences industries support critical processes where compliant management of all paper and electronic records and documents is essential. We recognize that your processes range from informal research collaborations to formal procedures like SOP review and approval, and that these processes may be limited to single departments, span your enterprise or even include alliance partners, contractors and consultants. Users can use a range of interfaces ranging from email clients, Web browsers, as well as office and specialty applications, allowing them to work in the environment that is most natural to them.

OpenText solutions for Pharmaceutical and Life Sciences are based on a framework providing the right task and resource support for the processes in the industry's value chain.