Computer System Validation (CSV) can often feel like a significant speed bump for growing companies looking to transition into the GMP space. It requires resources and considerations that are often not yet taken into account. While this may be more applicable to budding startups, veteran corporations can also find themselves …
Since the first major pharmaceutical breach reported in 2017 by Merck Sharp and Dohme, cyber attackers have increasingly targeted the biotech and pharmaceutical sectors. The strict regulatory compliance required in these industries creates complex digital environments, making them attractive and vulnerable targets for cyberattacks. Within a few years after the …
In software development for regulated industries, ensuring compliance with regulations such as 21 CFR Part 11 and EU Annex 11 requires a systematic and structured approach. In this blog, we explore how adhering to the principles of ISPE GAMP® 5, can guide software providers in aligning their activities to ensure …