CASE STUDY GLP Validation Success Through Specialization 119 14th St NW, Suite 100 • St. Paul, MN • 55112 • www.datasci.com scientificservices@datasci.com 1 Cambridge Healthtech Associates. (2011) Part One Final Report: Providing Pre-Packaged Validation Services for DSI’s Software Suite. Background: After initially outsourcing all of its GLP safety work, a large pharmaceutical company decided to bring GLP studies back “in-house” in order to reduce costs. They planned to begin with a safety pharmacology study that required the GLP validation of their Ponemah software systems used in such studies. The Challenge. Under ideal circumstances, the pharmaceutical company (client) would have conducted the GLP validation of their Ponemah systems using their own staff. H

Join for free to read