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Hello,
We are a Medical Device company and are ISO 13485 certified and also comply with 21 CFR par 820. We perform annual qualification (complete mappimg studies) of our storage chambers (i.e. cold room/refrigrator) on an annual basis but one of our suppliers doesn't. They mapped the chamber once back in 2005, and only perform annual calibration. Is that a sufficient approach or if they they should be performing a complete mapping study on a more frequent basis to ensure that the chamber continues to perform properly?
Thanks!
We are a Medical Device company and are ISO 13485 certified and also comply with 21 CFR par 820. We perform annual qualification (complete mappimg studies) of our storage chambers (i.e. cold room/refrigrator) on an annual basis but one of our suppliers doesn't. They mapped the chamber once back in 2005, and only perform annual calibration. Is that a sufficient approach or if they they should be performing a complete mapping study on a more frequent basis to ensure that the chamber continues to perform properly?
Thanks!