Case Study 5: Control and Monitoring Instrumentation
Peter Coady and Tony de Claire · 2013
INTRODUCTION Measurement and control instrumentation must be applied and maintained in support of computerized system validation. Unsatisfactory instrumentation can cause significant operational problems. This case study embraces the design and validation of both standard and intelligent instrument applications, and briefly discusses special instrument systems (shutdown systems and analyzer packages). Particular attention is focused on producing auditable documentation in compliance with GMP requirements (1,2).