Calibration is where a generic EAM system stops being enough
What’s in the whitepaper
A 10-page PDF, about 15 minutes.
- The compliance climate: calibration in the crosshairs
- Generic EAM systems: a generalist’s struggle in a specialist’s world
- Purpose-built GMP solutions: a different approach
- The business case for specialized calibration systems
Fully referenced, with a source listed for every statistic cited. A generalist Enterprise Asset Management (EAM) platform schedules work and tracks assets well. GMP calibration asks for things it was never built to do. Readings have to be captured as-found and as-left against a defined tolerance. Out-of-tolerance events have to route to investigation, not to a comment field. Intervals have to be enforced rather than suggested. The audit trail has to satisfy an investigator under 21 CFR 11.10, and the records have to stay inside the validated system. Configuration can close some of that gap. In a validated system, configuration means validation effort, change control, and a maintenance obligation that doesn’t end. This whitepaper examines where generalist platforms run out of road in regulated environments, which functional gaps put ALCOA+ data integrity principles at risk, and what a purpose-built alternative changes about validation effort and audit preparation. Start here: take your last three calibration deviations. For each, ask whether your current system prevented it, detected it, or only recorded it after someone else noticed. Anything in the third category is a functional gap, not a training problem.