Resource cluster
Management of instrument calibration, intervals, Out of Tolerance and data integrity.
How to organize a GMP-compliant calibration system: traceability, intervals, Out of Tolerance, audit trail, data integrity. Industrial metrology for those operating in a regulated pharmaceutical environment.
Calibration records are GxP data in every respect and must comply with the ALCOA+ principles. What this means in practice for those managing the metrology of a GMP site, with or without digital support.
The calibration interval is not a fixed value chosen once and for all. It is a risk-based decision that must be justified, reviewed and adapted to the instrument's historical data.
A critical instrument out of tolerance at the periodic calibration is not just an instrument problem: it is a potential retroactive deviation. How to conduct the impact assessment according to GMP.
Talk it through with a team that knows compliance from the inside.
