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Full Lifecycle CSA

ROQMetrics > CSV  > Full Lifecycle CSA

Full Lifecycle CSA

Tailor-made for Life Sciences, ValidateMyApp is a 100% paperless platform to manage the full GxP computer system lifecycle.

As a GxP implementation project manager, you need to communicate the status of your projects and the progress it’s making toward milestones to a wide variety of stakeholders from functional SME’s to executives, each with varying levels of information needs.

While your development team wants to manage the solution design and development in an agile way, in contrast, your quality team needs a way to manage the testing of the solution in a compliant way.

To meet these often conflicting demands, you need to align project management, system development, validation, and release lifecycles, and determine what deliverables (on all sides) can serve as reportable milestones. ValidateMyApp brings all 4 lifecycles together under a single tightly aligned solution to meet the needs of project managers, business analysts, developers, quality assurance, and release managers. With an intuitive workflow, pre-defined templates, and online collaboration tools, ValidateMyApp makes validation easier for everyone involved.

Initiation

Artifacts are the heart of ValidateMyApp. They document the process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner and meets the requirements of its intended purpose.

ValidateMyApp.com comes with the following set of predefined initiation artifacts that are ready to use out-of-the-box and based on decades of life science computer systems validation experience.

  • Project Charter – define your project, assign a manager, and monitor issues, resources, budget, and schedules.
  • Project Milestones – define project miles stones to manage and track major project events.
  • User Requirement – define the intended use of the solution.
  • Function Requirements – define the system capabilities required to achieve the intended use.

Planning

Planning involves collaboration between the project manager, developers, QA, and various subject matter experts to assess risk, create plans, create test cases, and provide traceability.

ValidateMyApp.com comes with the following set of predefined planning artifacts that are ready to use out-of-the-box and based on decades of life science computer systems validation experience.

  • System Risk Assessment – determine your quality and regulatory risk to better understand the overall system risk.
  • Functional Risk Assessment – determine functional risk and type of change to help develop your mitigation plan and testing strategy.
  • Validation Master Plan – document the scope and roadmap of the validation effort, including impacted product, processes, procedures, facilities, etc.
  • Installation Qualification – create a pre-execution protocol to verify the installation of the software in selected environments.
  • Operational Qualification – create a pre-execution protocol to verify that the software functions as described in its functional requirements.
  • Performance Qualification – create a pre-execution protocol to verify that the software performs as described in its user requirements for its intended day to day use.
  • Requirements Trace Matrix – automatically trace user requirements to test cases in a single document to be finalized and delivered at the end of the project.

Agile Execution

As more life science companies adopt agile approaches to system development and configuration, they can also benefit from injecting agility into the validation process. Traditionally, companies would validate solutions only when the entirety of the solution was ready.  Now, with ValidateMyApp, you can iteratively release working products much faster while retaining a validated state using our agile execution engine.

Plan

Product Owners can perform sprint planning in a collaborative way empowering stakeholders to participate in story grooming and prioritization.

  • Update user stories and acceptance criteria in real-time
  • Prioritize user stories based on the weighted shortest job first approach (WSJF)
  • Define the level of effort for user stories using a Fibonacci sequence

Build

Developers can provide up to the minute status during the development process. Management is empowered with instant insight into development progress via intuitive kanban boards.

  • Assign work to developers
  • or allow developers to pull work from the work queue
  • Visualize development status in a kanban board

Validate

The fully integrated test module allows complete control of the entire test process from test execution, defect management, resolution, and retesting. Testers execute test cases and pass/fail test steps electronically. Testers can raise deviations against failed test steps. Deviations are then routed to developers for resolution. Testers, QA, and developers can collaborate in real-time to address the deviation. System controls prevent the approval of test cases with un-resolved deviations. And test managers are notified of test case execution completion and availability for final review and approval.

  • Create and manage test cycles
  • Assign testers to test cases
  • Execute test cases online
  • Raise deviations
  • Route deviations to a developer for resolution
  • Route executed test cases for review and approval

Closeout

The Closeout phase is used to verify that all required documentation is approved, requirements are fully traced to tests, the validation summary report is completed, and the system is ready for release. System controls prevent the release of solutions that do not meet the minimum requirements.

  • Automatically aggregated test results into the validation summary report
  • Route the validation summary report for review and approval

Monitor and Maintain

The validation process is continuous and relentless. It carries on in an iterative manner throughout the system’s entire life with meticulous re-validation occurring whenever new features, hardware, or software are introduced to the system. ValidateMyApp allows for the revisioning of artifacts to add new requirements and develop and test new functionality.

  • Artifact Revisioning
  • Project Dashboard
  • Process Workflow Dashboard
  • Document Status Dashboard
  • Testing Status Dashboard

ValidateMyApp!

ROQMetrics, Inc,

701 E Santa Clara Street Suite 42, Ventura CA 93003

(877) – 221-0767

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