The following is part of the Compliance in Quality and Validation (CQV) series which presents real-life stories reflecting compliance problems in the pharmaceutical, medical device, and related industries.
This paper presents an overview of data integrity, defining the requirements for data reliability, providing a description of data-related issues, potential root causes, and US Food and Drug (FDA) regulatory requirements.
In an FDA regulated industry, routine inspections occur on a regular basis. Because of the important role quality control laboratories play in the testing and release of products, they are often an area of focus during FDA inspections.
What is risk and how do we begin to implement quality risk management systems? This paper illustrates the fundamentals of QRM and helps to adopt an action plan that keeps in mind potential threats.
The site VMP is a critical document. Early review of the VMP by regulatory auditors often sets the tone for the remaining days of inspection. A thorough and well-designed VMP demonstrates a well-run facility.