IQ and OQ validation of temperature-controlled devices typically includes confirming proper installation, compiling documents for each unit, verifying calibration, performing diagnostic and alarm tests, confirming alarm verification through client's on-line monitoring system, and finally conducting performance qualification that includes temperature recovery after loading samples and short term (1 hour) and long term (24 to 48 hours) temperature mapping using NIST / traceable thermocouples and data loggers. The final validation report includes certificates of calibration for all devices used; completed IQ, OQ, PQ protocols; hard copies of the raw and analyzed data and related attachments; and another copy of all data on a CD-ROM. One major area of concern for gathering and processing data is 21 CFR Part 11 compliancy. The Excel datasheets and the corresponding equations and test results are burned onto a CD-ROM to comply with 21 CFR Part 11 rules. |
