GxP Compliance Solutions

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cost of validation has caused companies to delay upgrades of business applications—often running two to three years out of date above the normally slow development cycles of legacy software applications.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.

SDS-Software Design

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.

Calibration Management Tracking for Audit Maintenance

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.

Traceability Matrix

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.

Maintenance Management Software Computer.

Best GxP Compliance Services

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

Qualer Software Solutions

Software similar to Lab Management Software. Join a thriving quality ecosystem of industry collaborators. Enjoy a complete data transfer from your current system. These services and more — at no additional fees — can completely transform your asset management and service.