Internal audits within the life science industry serve to evaluate a company’s internal controls to ensure compliance with laws and regulations for the safety and efficacy of products or services. Internal audits are performed by qualified individuals who do not have direct responsibility for the area that is being audited. Audits may be an anxiety-inducing word but can become much more inviting through efficient preparation, and results from an audit may even be used as powerful tools to continuously improve on one’s QMS.
Yes! The U.S. Award for Quality Excellence is known as the Malcolm Baldridge National Quality Award (MBNQA). In fact, the award was established as Public Law 100-107 by an act of Congress under the Reagan administration in 1987.
Before the submission of a 510(k) premarket notification, the purpose of which is to notify the FDA of the manufacturer’s intent to market a medical device,[i] there is a provision for acceptance review. This review serves as a method to assess whether a submission is administratively complete and includes all necessary information for FDA to determine substantial equivalence under section 513(i) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 United States Code (U.S.C.) § 360c(i)). To establish substantial equivalence under this provision, FDA must find the same intended use as the predicate device and either have the same technological characteristics as the predicate device or appropriate clinical and scientific data necessary to establish that the device is safe and effective as the predicate device. If the Authority is unable to determine substantial equivalence due to insufficient information, it may request for additional information to make that determination.
Last week, I touched on the idea of involving and empowering all employees in the workplace through the corrective and preventive actions process by fostering taking initiative and a problem-solving (refer to blogpost ‘The Art of Addressing Non-Conformances in Operations’). To expand on this concept a bit further, we’re going to be looking at Kaizen–a continuous improvement strategy in which employees at all levels are also empowered to solve problems towards big gains.
The pandemic has been a challenging time for all industries including the Food and Drug Administration (FDA). The FDA had to alter the manner in which it conducted its operations. One set of tools adopted by the FDA in response to COVID-19 was the remote regulatory assessment (RRAs).
At one point or another, you likely took care of a non-conformance within your operations. Non-conformances in quality management are deviations from a specification, standard, or expectation. For example, a primary packaging label with illegible print or an out of specification quality control measurement.
Following are some popular views about the cars mentioned related to quality management systems, above. Substitute the descriptions of the cars for descriptions of a company’s QMS and you’ll realize what the CEO is actually asking for in the conversation.
No matter what our perspectives may be or how they may differ, time is the one thing money cannot buy. It matters how we spend it. Quality 5.0 is coming2 and, although formative, it speaks of massive integration between humans and machines, digital neural interfaces, levelling of the economic playing field, increased longevity, global quality of life, ecological healing, and prolonged existence of humankind off-planet. I want to be ready for that!
Studies are indicating the increasing use of electronic nicotine delivery systems (‘ENDS’) products, particularly amongst current smokers,[i] warranting an evaluation over the need for these products and if they have the potential to do less harm, if not no harm. Some in the public health community have advocated for the harm reduction approach emphasizing on the use of ENDS as an alternative combustible to tobacco products that may contain more harmful or potentially harmful constituents.[ii] Regulating and controlling tobacco use in the era of e-cigarettes has therefore not been an easy task.
Clinical trials, when conducted with great care, are the safest and fastest way in having a treatment approved for use to improve public health1. A clinical trial is an investigation conducted under a protocol which assesses the efficacy and safety of a treatment in humans.
It is no surprise to anyone in the medical device industry that the transition from EU MDD to EU MDR has seen quite a few hiccups over the past couple of years. The most recent obstacle, however, comes in the form of delays from Notified Bodies. The scale of the bottleneck coming from Notified Body capacity to review EU MDR applications has not been a secret, but a recent industry poll sheds light on the growing concern.
A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to comply with the EU’s Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746)2, or EU IVDR, the equivalent to a CS was referred to as a ‘CTS’ (“Common Technical Specification”).