Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...

While most businesses invest in backup recovery systems, the majority skip the step of regularly testing them — which can ...

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued General Correspondence Letters to two third-party testing companies in China after uncovering falsified or otherwise invalid ...

The pharmaceutical world offers a valuable blueprint on how to harness AI’s efficiency while protecting trust, ethics and above all, people.

NIST’s National Cybersecurity Center of Excellence (NCCoE)—in collaboration with members of the business community and vendors of cybersecurity solutions—has built example solutions to address the ...

Kathleen Hurley is the founder of Sage Inc., a tech company that offers SMB businesses infrastructure solutions and next-gen technology. As data becomes everything to everybody, it’s crucial to ...

LIMS systems are used extensively in laboratories everywhere. As a tool in the lab we need to be able to trust the system to have the necessary data integrity. Just like the analytical methods, also ...

Following Viatris’ December announcement that a manufacturing plant in India had been written up by the FDA, a document published by the U.S. regulator reveals the details behind the company's ...