WHITE PAPER
Risk-Based Validation: Aligning with FDA CSA Guidance and GAMP 5
This white paper outlines how AssurX enables regulated companies to adopt risk-based Computer Software Assurance (CSA) practices in line with FDA guidance, global regulations, and GAMP 5 standards, replacing outdated Computer System Validation (CSV) methods.
Highlights include:
The Shift: From CSV to CSA
CSA marks a pivotal evolution from traditional CSV by focusing on value-added activities and patient safety. Steamlined activities include:
- Encourage risk-based decision-making
- Leverage vendor documentation
- Emphasize software fitness for use
- Reduce redundant documentation
The 4 Step CSA Validation Process
A methodology that enables faster validation cycles, better resource allocation, and more robust compliance.
- Identify intended use
- Evaluate risk severity
- Leverage vendor documentation
- Align testing type with risk
Mapping to the GMP 5 double-V model
Validation deliverables
AssurX Validation Services Package definitions
Strategic benefits of risk-based validation
CSA and risk-based validation are the new industry standard. With the right approach, companies can streamline validation efforts, reduce overhead, and maintain compliance with evolving global regulations.
Download this white paper and learn how AssurX empowers organizations to confidently meet CSA expectations by executing lean, focused validations that drive both regulatory success and digital transformation.
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