Focus on Pharma Episode 16: Data Integrity and Part 11: Take a Life Cycle Approach, Urges John Avellanet

Part 11 should really be called the Data Integrity guidance, says Cerulean Associates principal John Avellanet. In a recent interview, the compliance expert discussed the importance of audits, whether data is stored on- or off-site. FDA's new process validation guidance can help ensure data validity, he says.