Data collected from the study for a qualification or mapping must not only meet 21 CFR part 11 compliance but, must be Validated by the company performing the study or by the end user.
Alpha Controls uses three Validated software packages Fluke TQ-Soft, MadgeTech 4 Secure Software and Kaye AVS Validator Software. These are used for execution of protocols and providing specific data reports when performing IQOQPQ & Mapping needs.
According to the Health Canada, WHO, ISPE, guidelines the following reports must be included into the Protocol.
Qualification Summary Report: Synopsis of all the findings with recommendations for corrective actions on Deviations/Excursions, Hot & Cold Spots if found. Require a summary Report from Kaye AVS Validator software and an Excel file from TQ Soft or sensor location diagrams.