Preserve Data Integrity by Preventing Errors During Key Activities

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 a host of data to agency investigators, which expect that data to... Read more

Is Your Data Getting You in Trouble? Management Has Final Responsibility to Require Practices Aimed at Protecting Data Integrity

Jack Garvey |

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

Data Integrity: The Foundation of Medical Product Manufacturing Compliance

Jack Garvey |

The FDA and other global regulators rely on reviews of data during inspections to determine whether a pharmaceutical or medical device manufacturer is operating within regulatory requirements and expectations. The credibility of that data is a crucial parameter in the regulator’s assessment of whether... Read more