The validation landscape is evolving. Rigid, one-size-fits-all approaches are giving way to more intelligent, risk-based strategies. A hybrid validation deployment is at the forefront of this shift, blending the detailed rigor of traditional Computerized System Validation (CSV) with the agile, critical-thinking focus of Computer Software Assurance (CSA). This flexible strategy allows organizations to apply the right level of validation effort based on system complexity, novelty, and risk—ensuring robust compliance without unnecessary overhead.
But how do you implement such a flexible model without creating chaos? The key is a platform built for adaptability.
What is a Hybrid Validation Deployment?
A hybrid validation model isn't about choosing between CSV and CSA; it's about using both strategically. It acknowledges that not all systems carry the same risk.
High-Risk Systems: For complex, custom-developed systems with a direct impact on patient safety or product quality (e.g., a LIMS or MES), you might apply traditional CSV methods. This involves comprehensive documentation, formal scripted testing (IQ/OQ/PQ), and detailed evidence for every step.
Low-to-Medium-Risk Systems: For less complex, commercial off-the-shelf (COTS) systems with no customization, or those with an indirect impact on GxP, you can leverage CSA principles. This means focusing on critical thinking, targeted testing of high-risk functions, and leveraging unscripted and ad-hoc testing where appropriate, supported by robust vendor documentation.
The goal is to align validation effort with risk, ensuring that your most critical systems receive the deepest scrutiny while less critical systems are validated efficiently and effectively.
A hybrid model is essential for managing diverse system landscapes, especially those involving new cloud technologies, AI integrations, or frequent vendor updates.
How GoVal Enables a Seamless Hybrid Validation Model
GoVal is designed from the ground up to support a flexible, risk-based validation lifecycle. Our platform provides the configurable framework needed to execute a hybrid strategy, allowing you to standardize processes while adapting the level of rigor for each specific project.
1. Configurable Workflows and Templates
Your validation process shouldn't be dictated by your software. GoVal allows you to create and manage distinct validation pathways.
- CSV Pathway: Define templates that require comprehensive URS, FS, DS, and formal IQ/OQ/PQ protocols with mandatory, step-by-step evidence capture.
- CSA Pathway: Create streamlined templates that focus on intended use, critical requirements, and risk-based testing. Leverage vendor documentation and allow for unscripted or exploratory testing evidence.
You can assign the appropriate workflow at the start of any project, ensuring the validation team follows the correct, pre-approved process for that system's risk profile.
2. Dynamic Risk Assessment
A successful hybrid model hinges on accurate risk assessment. GoVal’s built-in risk management module is the engine that drives your strategy.
- AI-Assisted Assessment: GoVal AI can analyze system specifications to identify potential risks and suggest an initial GAMP category and impact assessment (High, Medium, or Low).
- Traceability to Risk: Every requirement can be linked to specific risks. This allows you to focus testing efforts on requirements tied to high-risk functions, perfectly aligning with CSA principles.
3. Adaptable Testing and Evidence Capture
GoVal supports the full spectrum of testing methodologies required for a hybrid approach.
- Formal Scripted Testing: For your CSV projects, create detailed, step-by-step test scripts with mandatory electronic evidence capture and e-signatures for each step.
- Unscripted & Exploratory Testing: For CSA projects, testers can perform and document unscripted or ad-hoc testing, attaching summary documents, screenshots, or videos as objective evidence. GoVal’s flexible evidence management ensures everything is captured in a compliant, auditable manner.
4. Centralized Traceability for All Pathways
Regardless of the validation path taken, GoVal maintains a complete, bi-directional Requirement Traceability Matrix (RTM). The RTM automatically links requirements to risks, tests, test evidence, and deviations for both your CSV and CSA projects. During an audit, you can instantly demonstrate coverage and control for any system, proving that your risk-based decisions were justified and well-documented.
5. Unified Reporting
With a single click, generate a Validation Summary Report (VSR) that consolidates all activities, regardless of the methodology used. The report reflects the chosen pathway, providing auditors with a clear, concise, and compliant record of the entire validation process.
Get the Best of Both Worlds with GoVal
Implementing a hybrid validation model doesn't have to be complicated. With GoVal, you can move beyond the rigid constraints of traditional validation and embrace a smarter, risk-based approach that enhances compliance, reduces costs, and accelerates your time-to-market.
Ready to see how GoVal can adapt to your unique validation needs? Request a demo today and discover the power of flexible, intelligent validation.