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 ...
From hearing aids to ultra-tech pacemakers, the medical device industry is a ground-breaking and innovative field full of opportunities. Though the manufacturers are passionate about delivering ...
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 ...
Companies in the life sciences, food, and cosmetics industries are all too aware of how fickle the market is, how dynamic their studies and those under investigation are, as well as their timelines ...
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 ...
Quality Records and Documents – Non-Conformances (NC), Corrective Actions and Preventive Actions (CAPA), Change Requests (CR), Bill of material (BOM), Complaints, SOPs, Work Instructions, ...
Polarion is a web-based application lifecycle management (ALM) platform that allows teams to manage requirements, test cases, defects, and other artifacts collaboratively. Polarion also provides a ...
When a company is issued an FDA 482 Notice of Inspection and FDA 483 Warning Letter, it must prepare and be ready for the long adventure it will have to take with the FDA. Receiving an FDA 482 means ...
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 ...
Documents and records prove that the company procedures align with compliance and regulation practices while designing, developing, and managing the life sciences products. It is a systematic process ...
The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance ...
The significance of FDA Computer Software Assurance (CSA) cannot be overstated when it comes to laboratory systems in today's technological era. Embracing the CSA methodology is crucial as it promotes ...
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