KENX INSIGHT

As capital projects and technology transfers wrap up and facilities grow nearer to startup, site leaders and team members may be filled with a sense of excitement or dread depending on their confidence in the site’s operational readiness…

This is a nontraditional view for understanding and navigating high-stakes change environments, such as FDA Warning Letters….

Emerging technologies are quickly playing a greater role in how the Pharmaceutical and Life Sciences Industry collects,
stores and interprets its data…

The Food and Drug Administration (FDA) has recently proposed dramatic changes to the current Computerized System  Validation (CSV) approach that is being used by most companies in the Life Science Industry...

Software as a Service (SaaS) is a cloud computing delivery model that promises various benefits, but also comes with unique risks. The life science sector has a very slow cloud adoption rate…

Successful product validation depends on operational readiness: facility and equipment, development knowledge with thorough analytical and process design documentation, trained cross functional staff at the manufacturing site and a robust formulation and process…

Despite having robust design and environmental monitoring, cleanrooms are at risk for several sources of contamination…

In 2018, the FDA released “Data Integrity and Compliance with Drug cGMP, Questions and Answers, Guidance for Industry.” Between 2015 and 2019, the number of 483 observations written globally increased by more than 10%. The increase indicates that…

In drug manufacturing, keeping track of data is crucial for the drug’s approval from the FDA. The “Continued Process Verification” (CPV) data needs to be maintained for ensuring that the product outputs are within predetermined quality limits…

A big reshuffle has been made in one of the principal guidelines for Commissioning & Qualification (C&Q) within the pharmaceutical industry today. The changes seek to improve the application of Quality Risk Management (QRM), a growing element of regulatory expectation…