GxP Best Practices Part 2: Early Stage Tips for 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 Challenges in Clinical Trial Oversight and Data Integrity In clinical trials, US regulations and global regulatory guidelines such as CFR 312 and ICH E6 R2 play crucial roles in ensuring […]
Data Integrity: The Foundation of Medical Product Manufacturing Compliance
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 of that data is a crucial parameter in the regulator’s assessment of whether operations are compliant—or not. Data integrity refers to the credibility—reliability, validity, authenticity, and trustworthiness—of various data presented for regulatory review. Questions […]
John (Jack) Garvey Has Been Selected by Our Partners QbDVision to Join Their Newly Formed Board of Advisors
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! Check out the LinkedIn excerpt below to learn more. LinkedIn Post QbDVision Taken from LinkedIn… “At QbDVision, we firmly believe that finding the right guides is just as important as […]
Risk Management and Data Integrity: Focusing on the Critical
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 use risk management approaches to rapidly reduce organizational risk in their data integrity efforts, by directing their […]
Sustainable Data Integrity Outcomes: Implementing Systems, Controls, Challenges and Governance
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 standards for being attributable, legible, contemporaneous, original and accurate (ALCOA) — characteristics that add up to data […]
Is Your Data Getting You in Trouble? A Look at FDA Requirements and Expectations
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 the FDA, rely on data to determine whether a manufacturing operation is compliant with cGMP and QSR […]
