Our client is an SQA department in a large Fortune 100 company.
Our client lacked an effective tool to manage their testing process. The testing team decided on HP Quality Center, but wanted a certified HP Business Partner to help them create a Proof of Concept, present to Senior Management, acquires Licenses. As well, a consultant experienced with Quality Center installation, configuring, and training was critical to be able to launch the tool prior to a large upcoming project.
SQA Solution provided a soup to nuts solution for the client involving a Validation Package with e-Signature for Quality Center to provide an efficient means for automating the management of the validation testing process within a regulated environment while delivering all of the benefits of using Electronic Signatures. The implementation of the Validation Accelerator provided measurable efficiencies into the validation process and streamlines the supporting test activities through automated test management.
We included a services engagement to configure Quality Center for our client’s particular compliance practices particular workflow in support of their specific validation testing process. The Validation Package for Quality Center included:
- 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 provided a turn-key validation project including validation documentation as well as consulting services to execute the validation scripts. Through our powerful solutions, we helped our client increase productivity and quality through benchmarks and best practices that are driven by our workflow in Quality Center.
- Improved Customer Experience – Easier FDA audits with secure and easily accessible records. Support internal workflows for document review and change control. Manage all quality assurance documentation centrally.
- Reduced Costs – Past experience means faster implementations. And, faster implementations mean fewer hiccups and downtime – all of which safe money.
- Expertise – Leveraging a certified Business Partner means getting a Quality Center expert who has access to a large network of HP expertise.
“We knew SQA Solution was well versed with Quality Center use and implementations. That was definitely a big part of our success in obtaining budget approvals and getting up and running on time.”
—QA Manager, Enterprise Quality Assurance
For more on how SQA Solution can help your company improve testing processes, check us out online at www.renttesters.com or call 1.888.789.1482.