Corrective And Preventive Action (CAPA) is often discussed as it is an alarming issue for the life sciences industry. Organizations consider its importance and try to deal with it better as CAPA's are ...

As the English saying goes, "Potato, Potato" doesn't translate well in the written form. Still, it's saying the same vegetable but with a different pronunciation, meaning it doesn't matter how you say ...

Change management is when an organization creates a step-by-step protocol to manage and implement modifications to products and processes. A change management plan is a protocol that implements and ...

Quality Records and Documents – Non-Conformances (NC), Corrective Actions and Preventive Actions (CAPA), Change Requests (CR), Bill of material (BOM), Complaints, SOPs, Work Instructions, ...

Maintaining Data integrity for medical devices is still a challenge in the current healthcare industry. Data Integrity means that information is accurate and has not been altered in any way. Incorrect ...

Medical devices, unlike prescription drugs, are reviewed by the United States (US) Food and Drug Administration (FDA) under one of two regulatory standards - Premarket approval (PMA), which requires ...

Development of AI/ML (Artificial Intelligence/Machine Learning) technologies has raised concerns regarding regulatory compliance. CSA/CSV (Computer Software Assurance / Computer System Validation) ...

ISO 13485:2016 is an international standard for medical device manufacturers and providers of quality management systems. ISO 13485:2016 is not a law or regulation and is voluntary, while FDA 21 CFR ...

There may be some misunderstanding surrounding FDA 21 CFR Part 11 when it comes to regulatory compliance for manufacturers of medical devices. We have discovered a major pitfall here: Many businesses ...

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medical devices' safety, efficacy, and quality. The agency has developed a rigorous medical device ...

The development of new medical devices or any new project brings a new set of risks. A Risk Management Plan (RMP) must be developed at the start of the Risk Management Process for a new project or ...

Bird-brained. Has anyone ever been called that? It’s definitely not a compliment. However, a bird’s eye view is considered good, like being in the crow’s nest or traveling straight as the crow flies.