CHANGE MANAGEMENT

Change Management

Change Management

Introduction

Change management process in most organizations is facing enormous pressure. In the cluster of large number of heterogeneous changes in information systems, pharmaceutical organizations recognize the need to align the process of change management to properly validate the changes and their impact on their information systems. Change management is closely connected with all project processes and functions, which are exposed to changes . Rigorous regulatory requirements are being driven to concentrate on change management practices in pharmaceutical organizations. At the same time, the volume of contents to manage changes that needs to be captured, dealt with, and maintained in support of the change management requirements continues to increase. According to leading analysts, up to 80 percent of IT changes are delivered late due to changing business environments . Projects intended to implement significant changes in the way an organization works seldom turns out as expected . Moreover, FDA binds the pharmaceutical organizations to well prepare the change management process. Change Management is considered to be more comprehensive, including not only changes to procedures but changes to equipment, specifications, etc. Change Management is more conducive to enable change to be made in a risk based manner taking into account the integral nature of pharmaceutical systems .

Over the last decade, many organizations have installed major information systems in their health care organizations

. There is an increasing demand for the systems that matches real user needs to manage changes and to document all relevant processes. Information systems are now considered central to most changes in health care . With the changing business needs, pharmaceutical organizations are focusing on process-based change management to better manage their CM activities. The discipline of change management deals with the way of developing a planned approach to change. Typically the objective is to minimize the disruption to the normal flow of the activities and to provide an efficient means of tracking changes to new and existing systems, applications, and environments within the information systems. This helps to maximize the efforts of all people involved in the change and to minimize the failure risk of implementing the change and the impact on other related systems. Change management ensures that CM process do not severely alter the system functionality, integrity, availability, stability or security, etc… by involving an excellent documentation to track all approved and planned changes.

One of the biggest challenges facing the pharmaceutical industry is how to manage and maintain the huge volume of documentation that is generated during the lengthy and complicated process of developing a new drug . An effective CM process enables centralized documentation of the completed changes, establishes responsibility and authority, and closely controls the developmental and/or validation environment prior to production. Any changes to the system must be thoroughly documented and managed by a change management process . In order to ensure that changes will occur, the basic awareness first needs to be converted into motivation through reasoning, and then into action through planning ...