HP’s Quality Center is the industry leader for automated software testing and test management. Quality Center provides a single centralized repository for all of an application’s quality assurance documentation throughout the project life-cycle.

SQA Solution’s engineers are the experts in implementing Quality Center in FDA, HIPA- regulated environments.

SQA Solution brings experience in a number of application environments common to life sciences:

• Training
• Validation with e-Signature
• SAP, Oracle E-Business Suite (and other ERP’s)
• Siebel (and other CRM’s)
• HP’s TestDirector for Quality Center
• Custom applications

BENEFITS

• Ease FDA audits with secure and easily accessible records
• Support internal workflows for document review and change control
• Manage all quality assurance documentation centrally

We also provide solutions that incorporate project management, application configuration and computer systems validation (CSV) for TrackWise implementations.

Validation Package

The Validation Package with e-Signature for Quality Center provides an efficient means for automating the management of the validation testing process within a regulated environment, and delivers all of the benefits of using Electronic Signatures. The implementation of the Validation Accelerator builds measurable efficiencies into the validation process and streamlines the supporting test activities through automated test management.

The Validation Package includes a services engagement to configure Quality Center for each organization’s particular understanding of compliance practices, and to accommodate an organization’s particular workflow in support of their specific validation testing process. Validation Package for Quality Center includes:

• Client Specific project template configuration, including workflow and eSignature implementation, validation documentation, and validation services
• Computer System Validation process Integration, including adaptation of tool to existing client validation processes, development of supporting procedures (i.e. QC project implementation procedure), as well as training, maintenance, and support

The Validation Accelerator leverages a comprehensive set of validation documents to accelerate the validation effort, including:

• Validation Master Plan
• Configuration Specification (CS)
• System Requirements Specification (SRS)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• SOP checklist
• Traceability Matrix
• Final Validation Report

In addition, SQA Solution can provide a turn-key validation project including validation documentation as well as consulting services to execute the validation scripts.

Through our powerful solutions we help organizations to increase productivity and quality through benchmarks and best practices that are driven by our workflow in Quality Center.

Case Study:

Implemented Quality Center for an SQA department in a large Fortune 100 company. Implementation included but was not limited to the following task: Create Proof of Concept, Present POC and Presentation to Senior Management for approval; Acquire Licenses, Installing the software; Configuring Production and Test Environments; Creating Training Documentation; Training the team on benefits and usability of QC, Customizing the tool to full fill client specific needs; Uploading all content (Test Requirements, Test Cases) to the QC and organizing them based on SQA structure. Integrating tool with Clear Quest Bug Tracking System; Implementing E-Signature for Validation and Compliance.

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