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CSV and CSA Implementation

Leverage ValGenesis technology to accelerate computer system validation (CSV) or enable risk-based computer software assurance (CSA) with the only flexible digital platform that accommodates both.

Benefits this Solution Provides

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Reduce Costs and Cycle Time by up to 50%

Eliminate non-value-added CSV and CSA activities and bring products to market faster.

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Ensure Regulatory Compliance

Demonstrate 21 CFR Part 11 and Annex 11 compliance with strong objective evidence and secure audit trails.

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Optimize Testing Efforts

Choose testing activities based on critical thinking and risk assessments powered by decision-tree logic.

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Empower Traceability

Ensure requirements have been adequately tested and reveal the impact of failures with dynamic trace matrices.

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Implement CSV or CSA in One Agile Platform

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  • Use critical thinking to assess the requirement impact on quality and safety and design appropriate test protocols. 
  • Apply decision-tree logic enterprisewide to measure GxP impact consistently. 
  • Utilize Agile methodologies to assess risk at the system or requirement level; balance testing efforts with the associated risk score. 
  • Determine appropriate testing methods (scripted or unscripted) based on the risk profile. 
  • Adopt quality best practices by streamlining the adoption of new technologies through appropriate validation decisions. 

Maintain Compliance

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  • Utilize a single source of truth for all things validation with a repository for all validated systems. 
  • Instantly access executed and supporting documents and audit trails with immutable time stamps and compliant digital signatures for speedy audit response. 
  • Standardize templates for consistency across the organization. 
  • Eliminate subjectivity with consistent risk assessment and associated test script development. 
  • Deliver data integrity through records-based execution and testing that adheres to ALCOA+ principles. 

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Promote and Improve Quality

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  • Detect issues and defects earlier, leading to higher-quality releases. 
  • Remove subjective human errors from the process to reduce the cost of quality. 
  • Demonstrate consistency, reproducibility, and accuracy as to intended use. 
  • Improve product quality through robust validation that spans the manufacturing process. 

What Can You Expect From Implementing Our Solution?

Before After
Test everything regardless of the impact on quality and safety due to an overabundance of caution. Apply critical thinking and only test what is necessary with a least burdensome risk-based approach to validation.
Error-prone, inconsistent paper-based processes lead to inefficient use of time and resources. Electronic protocol execution enforces consistent standards, captures objective evidence at the test-step level, and tracks all edits following regulatory requirements.
Manual change management is difficult to trace. A dynamically-generated change impact summary facilitates change management with required review and re-execution notifications.
Manual processes and multiple tools heavily burden resources and make collaboration challenging. A single platform enables collaboration and automates protocol authoring and test execution, saving time and resources.

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