Train the Organization, Not Just Engineers
Validation & QA Training That Embeds Process Discipline
Why This Training Exists
Situations that require capability uplift:
Releases stall due to unclear entry/exit criteria and shifting scope.
Audit preparation creates panic.
Evidence is incomplete or scattered.
Automation output increases without reducing product risk.
SOPs exist, day-to-day adoption is inconsistent.
Leadership needs reliable KPIs that tie to product outcomes.
Post-Training Operating Changes
Training converts theory into daily, governed practice across Validation & QA, with visible shifts in behavior, evidence, and delivery signals.
Shared language for risk and readiness.
Risk tagging at the item level.
Traceability by default.
Quality gates in CI/CD.
Focused automation.
Quality Operating System
Establish a governed, repeatable way of working that aligns product risk, roles, and suppliers with measurable outcomes.
Process Governance & Quality by Design
Establishes a repeatable operating model to deliver decisions aligned with product risk and regulatory expectations.
Leadership, Metrics & Improvements
Defines outcome-oriented KPIs, review cadences, and improvement backlogs that connect Quality work to business goals and sustain adoption over time.
Supplier/Vendor Quality Integration
Aligns partners to the same rules for ensuring third-party work plugs into the product’s compliance and release process.
Validation & Compliance Backbone
Create the documentation, controls, and traceability that withstand audits while staying lean and integrated with delivery.
Validation Fundamentals
Translates Agile delivery into validation artifacts and impact assessments mapped to realities, enabling lean, audit-ready documentation.
Traceability & Evidence Management
Builds end-to-end linkage from requirements to tests and defects, with controlled evidence capture and retrieval that stands up to audits without overhead.
Data Integrity & Controls
Implements ALCOA+ practices, audit trails, and ER/ES controls (21 CFR Part 11/Annex 11) to protect data credibility across tools and pipelines.
Test Engineering and TestOps
Direct testing effort toward risk reduction and delivery reliability, scale via stable automation and operational signals.
Risk-Based Testing & Test Design
Directs testing effort using risk matrices and proven design methods to maximize coverage where it matters most.
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Automation Governance (TestOps)
Shapes a stable automation portfolio tied to risk levels, integrates CI/CD quality gates, and manages flakiness and results retention for dependable signals.
Security &
Non-Functional
Embeds ASVS/OWASP criteria and realistic workload models into the backlog, producing actionable checks that protect confidentiality and integrity.
Turn Training into Measurable Practice
Start a scenario-led program where teams practice on live backlog items, generate reusable evidence, and integrate governance signals into planning, reviews, and releases.