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System Implementation

In order to bring products to market sooner and remain competitive, life science companies must carefully align technology with business needs. Systems must be selected, implemented, configured, tested, and validated using rigorous methodologies. The shift from totally custom development to configuration of commercial off-the-shelf systems that has occurred over the past few years may have altered but has not eliminated the challenges the pharmaceutical industry faces implementing new software systems. Companies try to achieve seamless integration of diverse systems and paperless processes while attempting to get information and capability into the right hands. This leads to a struggle in adapting traditional implementation methodologies to package implementation.

Many of the traditional implementation problems remain, including controlling scope, correctly estimating effort, understanding the complexity of work, dealing with technology changes, and managing expectations. The regulated environment creates challenges in finding qualified resources. Without a documented evidence trail, regulatory bodies will rule that activities have not been performed. Idexcel's system implementation services span the full life cycle and focus on helping clients leverage technology across the enterprise. Idexcel combines expertise in the latest software tools, products, & methodologies with a thorough understanding of the life science industry to help our clients leverage technology to meet their business needs. Regardless of whether we are implementing technology to automate the laboratory or to make use of electronic batch records in a manufacturing plant, our approach is founded on two key principles:

• An understanding of the business challenges in specific to life sciences industry
• Experience in the applicable technologies to address those challenges

Our clients also benefit from the knowledge that their technology strategy is being deployed by the experts in regulatory compliance.

Focus Areas

• System Analysis, Requirements and Specifications
• System Selection & Selected System Integration
• Configuration and Customization
• Testing & Data integrity for product physical stability testing
• Maintenance and Support
• System Retirement Planning
• Use of spreadsheets in Regulated Environments

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