How to Build Your Quality Nirvana
Transform Your Quality Culture
White Paper
Dec 18, 2019

Learn how thinking globally about enterprise quality management is key to meeting your customers' requirements and enhancing patient satisfaction.

Quality management is an integral factor in the development, approval and commercialization of medical devices and pharmaceutical products. This e-book provides insights on the challenges and opportunities in quality management, and highlights some best practices for creating Quality Nirvana.

What is the current state of the regulatory and quality landscape for life sciences organizations?

Life Sciences organizations, including Medical Device, Pharmaceutical and Biotech manufacturers, are experiencing unprecedented levels of change in the regulatory and quality landscape. In this global economy, value chains (which include the demand chain and the supply chain) are getting longer and longer. Achieving quality and regulatory compliance in this environment can be quite overwhelming.

To focus in, we can look at some of the most recent changes in regulations and standards that have either been initiated/implemented, revised, or are in the process of revision, and that affect Quality Management Systems for Medical Device companies.

Unique Device Identifier (UDI): The first change is the introduction of Unique Device Identifier (UDI). UDI often generates discussion regarding “ownership” within an organization: Does ownership lie with Quality, Manufacturing, Engineering, etc; but at a minimum, the Device Identification (DI) – which identifies the labeler and the specific version or model of a device - needs to be captured on Nonconformances, CAPAs, and Complaints.

If the Production Identifier (PI) - which is the variable portion of the UDI and identifies one or more of the following: batch or lot number, serial number, expiration date, and/or manufactured date - is available for Nonconformance, CAPA and Complaints, all the better. This new requirement from the FDA also impacts labeling and submission to the FDA’s Global UDI Database (GUDID).

 

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