PR-200-TX Qualer Validation Traceability Matrix - Qualer - Calibration Management Software
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PR-200-TX Qualer Validation Traceability Matrix
Qualer CFR 21 Part 11 Validation Service Document

Qualer was designed to meet the regulatory needs of GxP regulatory requirements of the Life Sciences and other regulated industries. Traditionally, the high costs of validation have caused companies to delay upgrades of business applications—often running three to four years out of date above the normally slow development cycles of legacy software applications. Qualer’s validation services and multi-tenant cloud architecture reduce the overall time and effort companies spend validating applications.

Qualer maintains validation according to the written standard established by the International Society of Pharmaceutical Engineers (ISPE) GAMP 5. Our validation service is executed in accordance with GxP standards producing a validation library that features the following document:

Validation Protocol Document

PR-200-TX Qualer Validation Traceability Matrix

The United States Code of Federal Regulations does not specifically require a Traceability Matrix (TX), but creating a traceability matrix is recognized as a validation best practice. It serves as a map for auditors to review the test case coverage from individual user, functional, and design requirements to the corresponding test cases that verify the system’s fitness for intended use.

Qualer provides a pre-configured business-in-a-box, best in class, software solution for progressive commercial calibration companies

Regardless if you are a commercial calibration company performing services for your clients or a in-house calibration organization working to meet your internal customers requirements, Qualer provides companies best in class functionality with our Calibration Management Software for the management and performance of calibrations and maintenance. Qualer’s  Calibration Management Software Cloud infrastructure enables calibration and documentation to be processed in real-time, increasing efficiencies and productivity, while reducing costs.

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Qualer CFR 21 Part 11 Validation Service

Qualer has retained the services of Ofni Systems Inc., a leading 3rd party CFR 21 Part 11 validation service provider, to validate the system in accordance with GMP standards. The validation protocol includes the following documents: