Contract Pharma recently published an article written by Timothy Rhines, Ph.D., Director in the Science and Technology Practice of Lachman Consultants. He discusses how to get your data integrity house in order.
Here is a brief excerpt from the article: “The global pharmaceutical industry has been grappling with the regulatory agencies’ focus on data integrity for the past several years. Data integrity guidance documents issued by regulatory agencies have resulted in the examination of the lifecycle of data coming from the analytical and microbiological laboratories. For a contract laboratory, reliability and trust in the data delivered to the sponsor are paramount.”