This review particularly highlights the fact that FDA inspectors do not limit themselves solely to traditional clinical records when verifying submitted data. Locating these other sources and ensuring consistency is vital to pre-inspection readiness. Sponsors, CROs and investigators must ensure that ...
FDA 21 CFR Part 11is a regulation established by theU.S. Food and Drug Administration (FDA) that sets the criteria forelectronic records and electronic signatures. The regulation ensures that digital documentation istrustworthy, reliable, and equivalent to paper records. It applies to all FDA-regu...
Under the Federal Food, Drug and Cosmetic Act, the FDA is required to inspect manufacturersat least once every two years—even morefor companies just getting started, those with a history of compliance problems, and those who have started producing products significantly different from what they pr...
Infectious disease doctors also play a role in the creation of vaccines that guard against disease and stop infection outbreaks. Jonas Salk, the virologist who invented the polio vaccine, is one example of an infectious disease physician who introduced a life-saving ...
both of which were associated with critical deficiencies in 2016. Similar FDA regulations are found in 21 CFR 11,Electronic Records; Electronic Signatures, and it is rarely, if ever, identified in either form 483s or warning letters. The FDA frequently associates these types of inspection ...
A letter is a warning sign – a chance to pull back before more serious actions, like a lawsuit, come into play, while an order is an official directive issued by a court, Both parties, whether the sender or the recipient, must understand the nuances surrounding cease and desist notices...
When driving, you may have noticed a button labeled “VSC” or seen a light on your dashboard with these letters. But what does “VSC” mean on a car? It’s a common question among drivers, and the answer is more than just a technical term. It’s a feature that plays a vital rol...
A good CAPA response to an audit investigation, such as an FDA 483, can limit escalation of the 483 into an FDA Warning Letter or other FDA action13. Much of the laboratory software currently in use may not have been developed with data integrity compliance as the core focus. For example...
A cease and desist is a written notice that alerts its recipient of an alleged violation of the rights of the sender. Courts and government agencies can issue cease and desist orders, which are legally binding injunctions. Individuals and companies can send cease and desist letters, but these ...
“At 200 Miles an Hour, the Loudest Noise in This New Tesla Model Y Is the Fart Sound” (adapted from David Ogilvy) “Have You Ever Wondered What You Would Look Like Without Pimples?” (adapted from Gary Halbert) “Exalted Comfort: When I Put On the Pair of Briefs What I Experienced...