MEDICAL DIAGNOSTICS COMPANY
BUSINESS PROBLEM
This federally regulated medical diagnostics company was upgrading its calibration software to the latest version of MS Office. To ensure compliance with 21 CFR Part 11 during the upgrade, they engaged a third-party vendor to perform a comprehensive validation of the upgraded systems, ensuring that the changes did not adversely impact their calibration software.
SCALESOLOGY IN ACTION
A comprehensive validation package was delivered and approved by the company. The package included a master validation plan, validation Standard Operating Procedures (SOPs), a test plan, detailed test cases, and executed test scripts.
RESULT
The validation package confirmed that the calibration software continued to produce consistent and reliable results following the MS Office upgrade, ensuring compliance with 21 CFR Part 11.
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