DECISION READINESS ASSESSMENTS
A clear-eyed evaluation of your current state. Where are decisions being made without evidence? Where does ownership disappear? We find the gaps and build the roadmap.
Quick Checkup
Rapid business use case guidance. Perfect for startups preparing for first FDA submissions or mid-market companies facing specific regulatory questions.
Targeted Scope Evaluation
Tailored strategic recommendations. Deep dive into your current validation approach with concrete improvement recommendations.
Deep Dive Review
Comprehensive custom validation roadmap for enterprise-wide transformation. Complete organizational assessment with prioritized action plan.
What you get:
A prioritized action plan with clear ownership assignments. Identified risks ranked by regulatory exposure. A roadmap your team can actually execute—not a shelf document.
TRANSFORMATION SOLUTIONS
Decision-Centric Validation (CSV / CSA)
Modernize your validation approach from documentation-heavy CSV to risk-based Computer Software Assurance. We redesign how decisions flow through your validation lifecycle.
What you get:
40-60% reduction in documentation. Faster releases. Audit-ready evidence that demonstrates thinking.
Decision Governance for SDLC & DevSecOps
Integrate quality governance into your development pipeline without killing velocity. We build decision checkpoints that catch risk early.
What you get:
Continuous validation in CI/CD. Reduced release cycle times. Clear accountability at every pipeline stage.
Decision Oversight for AI & Automated Systems
AI systems require governance frameworks traditional validation wasn't built for. We design oversight structures addressing model drift, explainability, and accountability.
What you get:
AI governance framework ready for FDA/EMA scrutiny. Documented decision authority for automated systems.
FRACTIONAL QUALITY LEADERSHIP
For emerging biotechs and growing companies that need Chief Quality Officer expertise without the full-time executive commitment. Strategic quality leadership + ForgeRx platform implementation.
Solutions Include:
- Executive-level quality strategy and regulatory guidance
- ForgeRx implementation and team training
- Quality system design for pre-commercial companies
- FDA submission readiness and inspection preparation
- Scalable quality frameworks
What you get:
Enterprise-level quality infrastructure without enterprise-level overhead.
Clear path to bring quality leadership in-house when you're ready.
ForgeRx operational backbone supporting quality decisions at scale.
APPLICATION MANAGED SOLUTIONS
Expert L1, L2, L3 support for your validation toolchains. Configuration management. Proactive oversight. So your teams can focus on the decisions that matter—not keeping the lights on.
What you get:
Reduced downtime and faster issue resolution. Optimized tool configurations. Internal teams freed from operational burden. Predictable costs with scalable support.