1. The V-Model Reimagined for Digital Speed
Computer System Validation (CSV) traditionally follows a rigid V-Model. While the logic is sound, the execution is often slowed down by paper protocols and manual evidence collection. QA Stack reimagines this by automating the link between User Requirements (URS) and Functional Testing.
Instead of weeks of manual testing, our **Automated Validation Engine** executes pre-defined test scripts across your configured environment, capturing results and electronic signatures in real-time.
The Three Pillars of Automated Execution:
Automated Installation Qualification
The system automatically verifies its own infrastructure—OS versions, database schemas, API endpoints, and network configurations—against the Master Configuration Specification.
Electronic Operational Qualification
Functional test scripts (e.g., "Verify electronic signature lockout") are executed digitally. Pass/Fail results are recorded instantly with direct links to the relevant 21 CFR Part 11 audit trails.
Continuous Performance Qualification
Instead of a one-time test, the system monitors actual production batch data to ensure the process remains within validated boundaries (CPPs/CQAs) over time.
2. Risk-Based Testing (RBT) Strategy
Not all functions are created equal. We apply a GAMP 5 Category 4 "Configured Software" risk-assessment to your implementation. We focus 80% of our validation effort on the 20% of functions that have a direct impact on product quality and patient safety.
Compliance Efficiency: By eliminating redundant testing of out-of-the-box features and focusing on site-specific configurations, we reduce the total validation documentation burden by over 40% while increasing regulatory robustness.
3. Electronic Execution & Automated Evidence
The "Paper-on-Glass" era is over. Our validation platform enables **e-Execution**, where the validator follows a digital script on a tablet.
4. Maintaining a Validated State
Validation is not a destination; it is a continuous state. Implementation includes the setup of the **Validation Maintenance Module**, which tracks all Change Controls and assesses their impact on the system's validated status.
In the event of a critical patch or configuration change, the system can automatically identify the specific "Regression Tests" needed to maintain compliance, preventing the need for a full re-validation of the entire system.