Introduction While many organizations have a dedicated Computer System Validation (CSV) team, CSV is never a solo effort.  That being said, how do we explain the concepts and basics to those who support CSV, but may not be too familiar with the process?  ISPE’s GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems is

What do we do when we need to validate ten or even twenty of the same computerized system? While it’s technically valid to create unique validation documentation and perform identical testing on each system, this is wildly inefficient from a time and financial perspective.  Instead, one can create a risk-based plan to validate a family

21 CFR Part 11 has been in effect for over 25 years, but in an ever-modernizing digital environment, Part 11 compliance is more important than ever. In a nutshell, Part 11 sets forth requirements that GxP electronic records and electronic signatures are required to meet.  While the scope of the regulation is not terribly difficult

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 in this situation. In an