PR-200-DS Qualer System Design Specifications - Qualer - Calibration Management Software
23000
page-template,page-template-full_width,page-template-full_width-php,page,page-id-23000,qode-social-login-1.0,qode-restaurant-1.0,ajax_fade,page_not_loaded,,select-theme-ver-4.1,wpb-js-composer js-comp-ver-5.4.4,vc_responsive
PR-200-VP Qualer Validation and Compliance Plan
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costs of validation have caused companies to delay upgrades of business applications—often running three to four years out of date above the normally slow development cycles of legacy software applications.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-DS Qualer System Design Specifications

The Software Design Specification (SDS) describes the system elements, functions, and configuration necessary to properly operate the system within the functional requirements outlined in the FRS. By meeting the requirements outlined in this document, Qualer will correctly and reliably perform its intended functionality.

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.

Ready to start innovating?

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: