Articles

Human factors remain a frequent precipitant of data integrity in pharmaceutical industry failures in GxP environments. This article outlines the regulatory expectations under FDA, MHRA,

Anyone who has sat through a regulatory audit knows how quickly small mistakes build up. A missing training record raises questions about broader compliance. A

A single misstep in logging production data. A forgotten password at a manufacturing terminal. An unsecured device connected to the shop floor. In pharmaceutical plants

Maximum Allowable Carryover (MACO) defines the maximum residue of one drug that can remain on equipment and potentially transfer into the next product, without compromising

Human error in pharma manufacturing continues to be a major cause of deviations and compliance gaps, and can go as far as product recalls, which

To Leadership Teams in Lifesciences, Healthcare, Biopharma, and Medtech: The choice of technology platform is no longer a purely technical matter. It directly affects operational

The global cosmetics sector stands at a critical juncture. Valued at $429 billion in 2022, the market is projected to double by 2032, reaching nearly

Medical device software is a fast-growing field. According to market research, the global market was valued at approximately $24.29 billion in 2023 and is projected

An FDA Form 483 is an official notification issued to manufacturing sites following an inspection, highlighting observed conditions that may violate any regulations or laws