March 27, 2020
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 […]
March 26, 2020
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 […]
March 3, 2020
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 […]
January 2, 2020
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-ready documents to determine whether a manufacturing operation is compliant with FDA’s requirements and expectations, as expressed (in theory) in a company’s own SOPs. But investigators won’t put in herculean […]
September 5, 2019
Are you a device or combination products manufacturer or service provider? 21 CFR 820 Connected to ISO 13485 AAMI has just released an important document mapping US 21CFR 820 to the Medical Device Standard ISO 13485. Suppose you have not started or are behind in your harmonization efforts. In that case, I strongly urge a […]
August 28, 2019
FDA inspection risk management is an essential activity for regulatory compliance within pharmaceutical and medical device companies. While it is often challenging for medical product manufacturers to incorporate risk-based principles into their quality and compliance approaches, it is essential that compliance-implicated documents are drafted in a way that considers risk principles to facilitate FDA reviews […]
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