MEDICAL DIAGNOSTICS COMPANY

BUSINESS PROBLEM

This federally regulated medical diagnostics company was upgrading their calibration software to the latest version of MS Office. In order to ensure 21 CFR Part 11 compliance during this upgrade, they wanted a 3rd party vendor to perform a complete validation on their upgraded systems to ensure it did not negatively impact their calibration software.

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SCALESOLOGY IN ACTION

A complete validation package was delivered and approved by the company. The package  included a master validation plan, validation Standard Operating Procedures, a test plan, test cases, and executed test scripts.

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RESULT

The validation package verified that the calibration software continued to produce results in a consistent and reliable manner after the MS Office upgrade confirming 21 CFR Part 11 compliance.