Validation Service Overview
Qualer was designed explicitly to meet the needs of GxP regulatory requirements in the Life Sciences & BioTech industries. Traditionally, the high cost of validation has caused companies to delay upgrades of business applications—often running two to three years out of date above the normally slow development cycles of legacy software applications.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’s validation service is executed in accordance with GxP standards producing a validation library that features the following documents:
URS-User Requirements Specification
The URS will address what end users require and describe technical, quality and documentation requirements of the Enterprise Asset Management Software.
FRS-Functional Requirement Specification
The FRS will address what functions the Enterprise Asset Management Software must be able to perform to successfully perform primary business functionality. This document also addresses regulatory and Qualer requirements for computer systems. The focus is on what the system must do.
The SDS will describe the system elements, functions and configuration necessary to properly operate the system within functional requirements outlined in FRS. The FRS must be approved before the SDS can be approved.
IOQ-Installation/Operational Protocol and Report
The IOQ will provide the instructions to verify the installation and operation of the Enterprise Asset Management Software. The SDS must be approved before the IOQ can be approved. The IOQ must be approved before it can be executed.
The TX will document that all requirements outlined in the FRS are properly described in the SDS and tested in the IOQ.
RRA-Release Risk Assessment
The RRA documents the results of the final risk assessment for the entire scope of functionality changed between Qualer versions. The assessment intends to objectively identify the level of risk introduced by the changes.
VSR-Validation Summary Report
The VSR summarizes the results obtained during the execution of the Installation/Operational Qualification Protocol for the Qualer Enterprise Asset Management Software. The Validation Summary Report will document whether the Enterprise Asset Management Software performed in accordance with its intended use as described in the Functional Requirement Specification and the Software Design Specification.
Version Release Process
For each major release of Qualer, we will provide advance validation support on the following schedule:
|Weeks Prior to Release||Deliverable||Description|
|8 Weeks||Release Announcement & Impact Assessment||Feature list, compliance assessment, validation plan|
|5 Weeks||Public Release Review||Public release announcement, sandbox environment access for customer evaluation of release features|
|3 Weeks||Pre-Release Environment Access and Validation Documents||Controlled validation test environment access, validation protocol updates and appendums|
|0 Weeks||Validation Summary Report||Executive report summarizing the release implementation and validation plan execution|
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