Abstract

People don’t talk much about the value of information but information is the strategic asset of a company. What makes the company great among other things is the ability to take information and use it as an asset. Information is what drives an organization, whether it is through development of new drugs, new products, looking into new geographic regions to expand to, etc.

Pharmaceutical companies are regulated industry and therefore are subject to strict compliance regulations. Document control and information governance in pharmaceutical companies are especially important.

This presentation covers the following topics:

• document control requirements per GxP/GMP requirements;
• GxP/GMP requirements for IT systems;
• proliferation of content;
• documents and legal exposure;
• documents and process inefficiency;
• social computing and its effect on information governance;
• documents and mobile computing and its effect on information governance;
• bring your own device (BYOD) and its effect on information governance;
• vulnerability of sensitive information;
• documents and crisis management;
• documents and E-discovery;
• role of documents in collaboration and new employees onboarding;
• documents and manual processes.