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Software Development Lifecycle Management

Incorporate agile methodology into your software validation processes to reduce risk, improve communication, and ensure product quality and patient safety.

Benefits this Solution Provides

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Implement Highly Adaptive Traceability

Link and trace user stories, requirements, and test protocols down to the step level to align with sprint and release cycles.

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Accelerate the Validation Process

Leverage test results from each iteration to determine adequate qualification while reducing over-testing by as much as 80%.

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Manage Entities More Efficiently

Establish versioning and required deliverables throughout sprint, testing, and release, aligning validation with the development lifecycle.

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Enhance Decision-Making

Intuitive analytics provide visualization of key Agile metrics, including burndown and capacity utilization.

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Design, Execute, and Manage Testing

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  • Assess risk at the requirement level, determine failure modes, perform criticality assessments, and develop action plans to mitigate risk. 
  • Use business rules to drive testing frameworks directly linked to assessment outcomes. 
  • Manage test failures with automated defect workflows to resolve errors mid-project. 
  • Incorporate test design and test plans to accommodate a variety of test types.

Coordinate Release Planning to Streamline Validation

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  • Establish a release plan and enable sprint scheduling. 
  • Design required deliverables based on unlimited content types, such as requirement documents, test protocols, plans, and summary reports. 
  • Leverage test lab data with the validation package to reduce future iteration testing by as much as 80%.

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Validate with Ultimate Agility

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  • Change or add requirements at any time while keeping sprints on schedule. 
  • Address scope changes while dynamically maintaining the requirements-to-test traceability matrix. 
  • Place new and incomplete requirements into the backlog at any time. 
  • Identify defects early in the process, leading to iterative improvement.

What Can You Expect From Implementing Our Solution?

Before After
More time is necessary because activities are sequenced and bound serially. The Agile approach requires less time and provides faster results to users for confirmation or course correction.
Users cannot see the system until it is complete, increasing the risk of not meeting the original requirements. Users can view results throughout the development lifecycle, facilitating communication between the development and validation teams.
Projects are more prone to failure. Potential failures are caught earlier in the development cycle, increasing the chances of project success.
Progress is difficult to measure or monitor. Progress can be measured daily.

Learn More From Our Experts

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Blog Post

Pharma 4.0

Validating Pharma 4.0 for Smart Manufacturing

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Industry Insight

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Read the Article

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Webinar

Cleaning Validation Programmes: Establishing a Compliance-Led Framework

Watch

See how ValGenesis can support your digital transformation.