This paper covers the basic technical elements to assess the risk to the integrity of CGMP e-records throughout the e-records lifecycle.
There are several low-cost ways to improve the security of network data files and, with a little creativity, organizations can go a long way to close the gap on protecting their important files without expending much in the way of resources.
IVT Network invites you to participate in our newest forum for quality and validation professional to discuss their actual work experiences.
Recent advances in culture-independent, DNA sequencing-based technology referred to as next generation sequencing (NGS) and metagenomics analysis now enable us to map, quantify, and characterize microbiomes.
This article will discuss the data integrity challenges with spreadsheets and how to implement a strategy that address current regulatory requirements.
The focus of regulatory agencies and the pharmaceutical industry has undergone a shift to also include data contamination which is also referred to as data trustworthiness or data integrity.
This discussion provides practical hands-on suggestions and examples to facilitate the protocol-writing process for equipment and other applicable qualifications.