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Dr. Elham Abdollahi-Mirzanagh
By Dr. Elham Abdollahi-Mirzanagh on September 15, 2022

Reliable data is the foundation of your entire product offering but ensuring its reliability is not always easy. Many life science companies rely upon the ALCOA+ framework to ensure data integrity. It is the gold standard set by different regulators all over the world for maintaining compliance with data integrity regulations such as U.S. FDA 21 CFR Part 11.

By Álvaro Spindola
on September 06, 2022

In July 2022, the International Society for Pharmaceutical Engineering (ISPE) released the 2nd edition of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems. It’s the most significant update since the first edition of this good practice guide was launched in 2008, and is likely to address many questions Life Sciences organizations have asked around ensuring GAMP compliance in line with technology shifts.

Franziska Hartmann
By Franziska Hartmann
on August 24, 2022

The age of industry and Pharma 4.0 has long been heralded, but many pharmaceutical companies are still reluctant to switch to fully automated processes. One reason for this is the fear that compliance with regulatory provisions, including those relating to data integrity in pharma, could suffer as a result. However, automation is a solution to counteract the challenges of the pharmaceutical industry’s rapid growth combined with the shortage of skilled workers. This article is intended to dispel the reader's fear of automated processes and to show that investing in automated processes offers financial advantages and simplifies compliance with data integrity regulations.

Dr. Thaleia Papadopoulou
By Dr. Thaleia Papadopoulou
on June 30, 2022

Authors: Chong Yang Gue and Dr. Thaleia Papadopoulou

If you missed How Pharmaceutical Companies Can Implement Agile Methodology Part 1 of 2  about how to successfully implement Agile in pharma, we suggest you start there to learn about general Agile development methodology and, specifically, how it can be incorporated in an Agile pharmaceutical development environment. In part 2 we look at the tests and approval approaches adopted in Agile applications within GxP scenarios. 

Dr. Thaleia Papadopoulou
By Dr. Thaleia Papadopoulou
on March 22, 2022

Authors: Chong Yang Gue and Dr. Thaleia Papadopoulou

In a constantly changing world that is dominated by uncertainty, many industries have already adopted Agile software practices, aiming at enhancing flexibility within their business processes and enabling innovation. Although the medical device sector has already embraced Agile within their systems and business organization, the pharmaceutical industry is still behind, mostly due to compliance concerns and misconceptions regarding regulatory expectations in a GxP environment.