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

Consideration of ICH Guideline, Industry Norms Necessary for Compliant Clinical Quality Assurance Plan

Teresa Gorecki |

Savvy companies already understand that Quality Assurance (QA) must be integrated into the clinical development system, not relegated to an afterthought of audits and quality control (QC) checks. But exactly how should this be accomplished? Review of current... Read more

Investigations, Analyses and Conclusions: Finalizing Well-Written, Inspection-Ready Documents

Jack Garvey |

Well-drafted, easy-to-understand quality records are crucial to helping pharmaceutical and medical device manufacturers navigate FDA inspection obstacles. The FDA relies heavily on information presented in inspection-implicated documents to determine whether a manufacturing operation is compliant with FDA's requirements... Read more