1. Release Management: Plan, organize, and manage your Software Releases and Versions, Patch Management, Handover process, Configuration Management, set up and configured Test and Production Environment. Attach your Validation Plan to each Release, release information from the suppliers, manuals, installation manual, etc. You can manage all your validated software solutions in different HP Quality Center projects with a specific setup and references. Each project can be assigned to different project team members and user access rights. Enable the usage of electronic signature for review and approval cycles. 
2. Requirements Management: Organize and manage all your system's requirements, with different requirement types, including a functional, quality-related and technical risk ranking. Assign and email requirements to other groups or persons. You will have different view and sorting options, making the requirements management easy and traceable. Each requirement can also be assigned to different Releases or Patches. During test execution you can clearly see the status for each requirement. 
3. Test Plan: Specify your test specification and script, prepare test data and test environment, link test cases to requirements, create a test execution order, assign testers (subject matter experts) for each requirement, re-use test scripts for regression testing automatically.
4. Test Lab: Execute the test, manually or automatically. Attach screenshots electronically to your pre-approved test execution scipt, review and approve test sequences, analyse test results with severity and priority, create automatically defect entries, email results from testing directly to responsible persons.
5. Defects: Error handling in relation to the Release Management module, specify where the defect was found, when should it be fixed, when re-tested.  

Also HP Quality Center offers different powerful reporting and signature features. The creation of a traceability matrix of your project needs just one button click. Our special GxP setup and configuration including add-ons offer different additional functions and features, so that the product is ready-to-use for the regulated environment:

• 21 CFR Part 11 compliance including the usage of electonic signatures and audit trail functions
• Front-end studies for the transfer of paper-based to electronic processes 
• Validation of HP Quality Center and reporting functions
• Configuration of HP Quality Center
  • Implementation of your Validation Policy and SOPs
  • Customization of your "validation language" to HP Quality Center
  • Transfer of Validation and Project Plans, Test Plans, Test Specifications, Test Cases and Reporting
  • Interfacing with other tools or solutions, e.g. for the Software Development Life Cycle (SDLC)
  • Integration of ISPE GAMP Good Practice Guide "Testing" and other standards like CMMI 
• Administrator, End-User, Supplier Training and ongoing project support

A modern and holistic Validation Approach with HP Quality Center:

• Manage system, process, technical and procedural requirements throughout the entire system and validation lifecycle
• Prioritize testing priorities based on quality and business risk
• Access testing assets anytime, anywhere via a browser interface, during an Audit or on Supplier site
• Create an end-to-end quality management infrastructure for all validated solutions
• Manage manual and automated tests: Accelerate testing cycles by scheduling and running tests automatically, unattended, 24x7
• Manage multiple versions of requirements, tests, test scripts and system configurations
• Enforce standardized processes and best GAMP practices
• Analyze the validation status and readiness at any point in the testing process with integrated graphs and reports

Contact us today to get more information about the usage of validation tools and best practice approaches.

Watch here the Quality Center demo: