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What is the requirement for dealing with an instrument that was sent for annual calibration, but was found out of range?

With regards to the validation studies performed throughout the year, does it negate the temperature studies?

The equipment was used within its calibrated period but the annual calibration found it out of specfic. There are 4 temperatures were measured during the re-calibration. it passed for 65, 100 and 300, but failed at 150. Unfortunately, the validation work hovered between 100 and 150.

I dont this should be an issue. The requirement is that calibrated equiipment be calibrated to acceptable standards and its within its calibratied period. correct?

thanks in advance.

Impact assessment on validation study needs to be evaluated, if the out of calibrated instrument impacted the out come the result, you can go for re-validation with corrected/new instrument, there is no alternation for that.

[quote=wes77]What is the requirement for dealing with an instrument that was sent for annual calibration, but was found out of range?

With regards to the validation studies performed throughout the year, does it negate the temperature studies?

The equipment was used within its calibrated period but the annual calibration found it out of specfic. There are 4 temperatures were measured during the re-calibration. it passed for 65, 100 and 300, but failed at 150. Unfortunately, the validation work hovered between 100 and 150.

I dont this should be an issue. The requirement is that calibrated equiipment be calibrated to acceptable standards and its within its calibratied period. correct?

thanks in advance.[/quote]