` Validated Software Data
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361 Steelcase Road West
Unit 6
Markham, ON  L3R3V8 - Canada



(905) 477-2133


(905) 477-4219

Validated Software Data


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.



  • The site survey, showing EDLM locations.
  • The raw data, presented using the appropriate test data sheet format.
  • Spreadsheet data and related temperature graphs for every EDLM used in the mapping exercise.
  • Raw results of the data analysis and Statistical reports for Min., Max, Avg. Std. Deviation and the Hot & Cold Spots.
  • Key documents and notes prepared during the mapping exercise, together with any other supporting material.
  • Deviation reports, including Corrective and Preventive Actions (CAPA) forms, if required.
  • Calibration certificates for all EDLMs used.

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.