Making the conscious shift to adopting risk-based Computerised Systems Validation
QUASAR #162 2023:
REVALIDATING THE MIND: MAKING THE CONSCIOUS SHIFT TO ADOPTING RISK-BASED COMPUTERISED SYSTEMS VALIDATION
Confidence of in-house system validation has grown over the past decade or so, as the regulations and guidance have remained relatively constant during this time. Procedures and technologies have developed to support such practices. Unfortunately, time and time again the same feedback is observed – CSV takes too long and relies too much on quantity of documentation.
In the 2023 Quarter 1 issue of RQA (Research Quality Association) Quasar magazine, John Cheshire, our Senior QA Validation Officer discusses why the industry should be adopting risk-based CSV.
Author: John Cheshire
John is a Senior Validation Officer. He has experience in both GMP auditing and CSV QA where he is championing the adoption of risk-based approaches to Computerised System Validation. John holds an MSci in Biological Sciences and he is trained in Lean Six Sigma principles.