Improve business performance and rapidly introduce new products
The life sciences industry is one of the most complex in the world. Companies developing pharmaceuticals, medical devices, biotechnology, and even nutriceuticals need a responsive IT infrastructure with the ability to control compliance costs. Improving business performance as they work to bring new products to market in a timely manner is crucial. The explosion in the need for research, development, and regulatory compliance is driving the demand for a more flexible computing environment. Nothing is more critical than access to real-time information on production processes and business operations. Life sciences companies depend on this data to make sound business decisions, maintain compliance, and run efficiently.
Time-to-market and profitability pressures are intense. Many times, being the first company to market and patent a new product is a key indicator of potential success. Often these needs are balanced against demand for manufacturing existing products. Microsoft Dynamics solutions, along with our partners’ deep vertical expertise, enable life sciences organizations to quickly deploy an integrated set of leading-edge business applications inexpensively, and without complicated customizations, to help address these challenges.
Meeting regulatory requirements
Maintain audit trails and signature records for both manual and automated transactions to satisfy 21 CFR Part 11.
Monitor quality control and overall quality management processes.
Restrict sales to unqualified customers.
Maintain compliance with appropriate cGMPs (current Good Manufacturing Practices).
Trace products and supply-chain transactions.
Data management throughout the life cycle
Rely on real-time access to information.
Facilitate the selection of promising targets quickly and efficiently.
Manage clinical trial data and track adverse events.
Maximize acceptance and manage multiple sales channels.
Prepare audit trails from engineering through production.