In the life sciences industries, documentation plays a crucial role in proving the product's effectiveness and safety. Furthermore, it discusses the processes and practice's dependability, ...

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 ...

As the pace of digital transformation and automation accelerates, the need for a robust and lean risk assessment methodology for software is becoming more and more critical in the life sciences ...

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 ...

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.

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

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 ...

FDA issues warning letters to avoid compliance. Warning letters are issued when the FDA finds that a company from the life science industry is out of its way with the regulatory standards in quality ...

For health and life sciences organizations, compliance with regulatory requirements is non-negotiable. Historically, Computer Systems Validation (CSV) has been the focus of QA and compliance ...

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 ...

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 ...

Quality Management Software is designed to document processes and procedures and streamline quality policies in compliance with ISO (International Standards Organisation) and the FDA (Food and Drug ...