Utilizing SOPs to Fill Computer System Validation (CSV) Gaps
Ten years after our original discussion of Computer System Validation (CSV) gaps,
Laboratories still face frustrating roadblocks. In 2015, the three core CSV challenges were systems that:
- Did not function as intended
- Did not meet an aspect of 21 CFR Part 11
- Did not meet a general CSV requirement
Although these challenges remain relevant, the landscape has evolved with increasing data integrity concerns, cloud solutions, automation, AI, and cybersecurity threats.
Today, software configuration isn’t always sufficient to meet regulatory requirements. Standard operating procedures (SOPs) can be crucial for bridging validation gaps. Here, we explain how to strategically use SOPs to address these persistent and emerging challenges.
