Few industries are as heavily regulated as the pharmaceutical and life sciences industries -- and for good reason. While life sciences companies seek to reduce the time it takes to bring new products to market, Federal Drug Administration (FDA) and other government regulations help to ensure that the new drugs are rigorously tested for safety, efficacy and minimal side effects.

Life sciences companies rely on our extensive knowledge and experience to help them manage the complex and sophisticated computer systems validation process. Our best industry practices help to confirm the accuracy and integrity of data in computerized systems – and ensure product safety, effectiveness, and regulatory compliance. We know the industry because we come from the industry.

Mandated by the U.S. Food and Drug Administration, Computer System Validation (CSV) is a critical requirement for any life sciences company. CSV verifies that computer systems and their associated applications operate in a consistent fashion and yield reproducible results based on their intended use. Such validation is aimed at ensuring patient safety, product quality, and data integrity when manufacturing regulated products.

Computer System Validation (CSV) is a critical requirement for any life sciences company. CSV verifies that computer systems and their associated applications operate in a consistent fashion and yield reproducible results based on their intended use. Such validation is aimed at ensuring patient safety, product quality, and data integrity when manufacturing regulated products. CSV is a stringent requirement of the US Food and Drug Administration (FDA).

Moving to the cloud used to be a daunting proposition. Issues such as reliability, data security, availability and scalability had many life sciences companies reluctant to take advantage of this “new” technology.

Not anymore.