White Paper Download – Streamlining and Accelerating Change Control In Today’s Complex Life Sciences Organizations

In today’s highly regulated life sciences environment, organizations face a myriad of regulations and regulators, affecting all aspects of the enterprise. One area coming under increased regulatory scrutiny is change control: the ability to manage deviations to established policiesand procedures in a way that is efficient, timely and compliant.

A true enterprise solution provides the organization with a single point of visibility and control for change management across all countries, departments, and sites. At the highest level, it allows an organization to apply a common set of enterprise standards, rules and requirements built around compliance saying, “This is how we will manage change control. These are the people responsible for initiating, approving and closing events. This is how we’ll make certain all change control actions are routed to the appropriate individuals or escalated when required. This is how we will track and report change control activities for business management and compliance purposes.”

This paper by QUMAS examines why it is absolutely vital for organizations to take a comprehensive, closed-loop approach to automating change management, spanning all areas of the organizationand extending throughout the product lifecycle. The key attributes of an effective solutionare described including:

1. A single point of visibility and control for the enterprise
2. Flexible configuration to meet unique country, department, and site needs
3. Robust integration with key business and product lifecycle systems
4. A closed loop approach to monitoring and validating change control
5. Automated workflow processes that streamline the completion of change management tasks.

Click here to download this white paper today! QUMAS will be exhibiting at BioPharma Asia Convention 2012. Pre-register to visit the exhibition today.