Data Integrity

In Teresa Gorecki's second session of Executive-level GxP training, the two reviewed Regulatory Compliance Fundamentals for Early-Stage Development​, emphasizing the importance of data integrity. Evolving

The FDA and other global regulators rely on data reviews during inspections to determine whether a pharmaceutical or medical device manufacturer operates within regulatory requirements and expectations. The credibility

We are excited to announce that our CEO, Jack Garvey, has been selected by our partners QbDVision to join their newly formed board of advisors!

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

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

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