Risk Management and Data Integrity: Focusing on the Critical

Jack Garvey |

The FDA has long taken a risk-based approach to manufacturer GMP compliance expectations and enforcement actions, as well as requiring pharmaceutical and medical device manufacturers to do the same in their quality system operations. Similarly, companies can also... Read more

Systems, Controls, Challenges and Governance for Sustainable Data Integrity Outcomes

Jack Garvey |

Being able to present data that the FDA believes it can trust is critical to making it through an inspection unscathed. Medical product manufacturers must provide myriad data to agency investigators, which expect that data to meet its... Read more

Is Your Data Getting You in Trouble? A Look at FDA Requirements and Expectations

Jack Garvey |

Data drives the pharmaceutical and medical device industries. It informs the manufacture and release of medical products to patients and consumers, and determines which products are approved for sale in the US and other markets. And regulators, like... Read more