By Mike Jovanis, Vice President of Vault QualityDocs, Veeva Systems
Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.