THE VALIDATION
VECTOR.
GxP Compliance, Accelerated. We apply Risk-Based Validation (CSA) principles to turn a 6-month paperwork nightmare into a 6-week sprint.
THE BOTTLENECK
Your team bought the license, but the system isn't 'Go-Live' ready. Internal QA backlogs and complex regulatory requirements (21 CFR Part 11, Annex 11) stall your launch.
The Old Way (CSV): "Validate every single button click."
Result: Months of delay and thousands of pages of low-value documentation.
THE ACCELERATOR
We provide "Validation as a Service." We come in with pre-written test script libraries for major RBQM tools (CluePoints, CDS) and R-Shiny frameworks.
Our Way (CSA): "Focus testing on high-risk features and critical data flows."
Result: Inspection-ready compliance in weeks, not months.
CALCULATE YOUR SAVINGS
See how much time and budget you can reclaim by switching from traditional CSV to Vector's Risk-Based Validation (CSA) approach.
RBQM ROI CALCULATOR
Estimate the financial impact of transitioning from traditional monitoring to Risk-Based Quality Management.
Study Parameters
Cost Assumptions
Unlock Detailed Analysis
Enter your email to reveal the full cost breakdown and download the PDF report.
Est. Savings
$---,---
Visit Reduction
--%
ROI
--%
* Estimates based on industry averages: 25% reduction in on-site monitoring visits.
WHAT WE DELIVER
Validation Plan (VP)
Defining the strategy. We determine the scope of testing based on a formal Risk Assessment (CSA approach).
IQ/OQ/PQ Scripts
Installation, Operational, and Performance Qualification scripts customized to your specific configuration.
Validation Summary Report
The final "Green Light" document for your TMF. Signed, sealed, and ready for inspection.
SPEED TO GO-LIVE
*By leveraging pre-validated libraries and a risk-based approach, we eliminate 75% of the manual documentation burden without compromising compliance.
FREQUENTLY ASKED QUESTIONS
What is the difference between CSV (Computer System Validation) and CSA (Computer Software Assurance)?
CSV is the traditional approach: comprehensive documentation of every system function, extensive test scripts, and full traceability matrices. CSA is the FDA's modernized approach (introduced in 2022) that focuses validation efforts on critical functionality based on risk. CSA allows you to leverage vendor validation documentation, reduce redundant testing, and focus on configuration-specific risks. The result: 75% less documentation with equivalent regulatory compliance. Both approaches are FDA-accepted; CSA is simply more efficient.
How long does RBQM platform validation typically take?
Traditional CSV validation takes 4-6 months from planning to final approval. Our CSA-based approach reduces this to 6-8 weeks: (1) Risk Assessment & Planning (1 week); (2) IQ/OQ/PQ Script Development (2-3 weeks); (3) Test Execution (2-3 weeks); (4) Validation Summary Report & Approval (1 week). This assumes the platform is already configured and data integrations are functional. If configuration is still in progress, add 2-4 weeks.
Do we need to validate our RBQM platform if we're using a commercial vendor like Medidata or Veeva?
Yes. While vendors provide pre-validated documentation for their base platform, you are still responsible for validating your specific configuration, custom KRIs, data integrations, and workflows. This is called "configuration validation" or "implementation validation." The FDA expects sponsors to demonstrate that their specific implementation works as intended and meets GxP requirements. Vendor validation documentation reduces your burden, but it doesn't eliminate it.
What happens if we fail an FDA inspection due to inadequate validation?
Inadequate computer system validation is one of the most common FDA inspection findings. Consequences range from Form 483 observations (requiring corrective action) to Warning Letters (requiring formal response and remediation). In severe cases, the FDA may issue a Clinical Hold, preventing new patient enrollment until validation deficiencies are resolved. This can delay your study by 3-6 months and damage your regulatory reputation. Proper validation upfront is far less costly than retrospective remediation.
Can you validate a custom-built RBQM dashboard (e.g., R Shiny, Power BI)?
Yes. Custom dashboards require more extensive validation than commercial platforms because there is no vendor validation documentation to leverage. We follow GAMP 5 Category 4 (configured product) or Category 5 (custom application) guidelines depending on the level of customization. Our validation package includes: User Requirements Specification (URS), Functional Specification (FS), Design Specification (DS), Risk Assessment, IQ/OQ/PQ protocols, and Traceability Matrix. Typical timeline: 8-10 weeks. We've successfully validated dozens of custom RBQM dashboards with zero FDA inspection findings.
How Validation Works
Risk Assessment
Categorize system criticality
Test Planning
Define validation strategy
Script Development
Create test scripts
Execution
Run validation tests
Documentation
Complete validation package
Risk Assessment
Categorize system criticality
Test Planning
Define validation strategy
Script Development
Create test scripts
Execution
Run validation tests
Documentation
Complete validation package
Related Services
Explore complementary services that work well together
Staff Augmentation
Fill critical RBQM capacity gaps with embedded Quality Systems Specialists who own validation documentation and audit preparation.
Solution Delivery
Get custom RBQM analytics and dashboards built for your trial with built-in validation documentation and compliance.
System Analysis
Optimize your existing RBQM platform configuration and ensure your workflows are audit-ready before validation begins.