CSV and CSA Implementation

Benefits this Solution Provides

Reduce Costs and Cycle Time by up to 50%

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

Ensure Regulatory Compliance

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

Optimize Testing Efforts

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

Empower Traceability

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

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.

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.

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.

ISO 9001 Certified compliance services provider since 2021.