Engagement Models
Start Where It Hurts. Use What Works.
Two Connected Domains. Six Pillars. One Operating Model.
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Seamless Technology Onboarding
Technology adoption should accelerate progress not create new barriers.
AuraGxP leverages its proprietary AuraTrace platform which is designed for rapid onboarding through configuration along with a delivery process that minimizes the burden on our customers. Your implementation package will include system configuration, system validation (IQ/OQ/PQ), UAT test scripts, and user training. Data migrations can be done by your team or ours.
Fixed Fee Sprints
Need an immediate solution to a critical challenge? Our fixed fee sprints deliver focused outcomes within clearly defined timelines and budgets.
From gap assessments to audits to vendor selection, our sprints support defined-scope quality, learning, and vendor governance activities. Each sprint is designed around a specific objective, agreed deliverables, and measurable outcomes, eliminating scope creep and reducing uncertainty.
Fractional Experts
Access senior industry experts with decades of industry experience, without the cost and commitment of a full-time hire.
Our fractional model gives you immediate access to experienced leaders with quality and vendor governance expertise. Whether you need interim leadership, strategic oversight, or hands-on execution support, our proven experts become an extension of your team.
Fractional Support Staff
Need help with day to day activities but not ready for a full-time hire.
Our fractional support staff model gives you a defined number of hours of support per week from the same resource. AuraGxP will provide specialized support staff to help with your day to day quality or vendor governance activities.
On-Demand Advisory
Sometimes you need immediate answers and don't have time to set up a new contract.
Our on-demand advisory service allows you to pay a small retainer so that resources are available right when you need them, not weeks later. You'll have direct access to specialists who understand the complexities of GxP environments on call. From navigating regulatory challenges and evaluating technology decisions to troubleshooting operational bottlenecks, we help you make informed decisions with confidence.
Foundation, Growth, Enterprise.
Each package combines AuraTrace™, implementation, consulting, and managed services in one coordinated program, so nothing gets lost at a handoff.
Your first quality and vendor management infrastructure, without over-engineering it.
What's included
- Document management, learning management, audit management
- Vendor management and RFP management
- Configuration, workflows, roles, approvals
- Validation package: URS, risk assessment, test evidence
- Admin and end-user training with go-live sign-off
- Gap analysis and SOP development
- CAPA, deviation, and audit program design
- RFP for initial vendor selection; qualification audits
- Document control and training records
- Vendor performance monitoring
- Change-order and scope-creep support
Formal quality and vendor governance for multiple active vendors and rising scrutiny.
What's included
- Full quality workflows where needed; document control and learning for everyone else
- Vendor management bundle and RFx evaluation
- MCP Connector to your enterprise AI
- Extended configuration and multi-team roles
- Full validation package with traceability matrix
- Deeper SOP library, CAPA maturation, deviation trending
- Portfolio vendor risk scoring and preferred vendor list
- Quality agreements; vendor audits; mock FDA inspection support
- Full document control, submission support, inspection hosting
- Full vendor lifecycle: QBRs, milestones, escalations
Enterprise-wide traceability when a compliance gap at BLA, NDA, or launch isn't an option.
What's included
- Full document control, learning, and quality workflows
- Vendor management and governance with RFx evaluation
- MCP Connector and advanced AI workflows
- Multi-site configuration and role hierarchy
- Comprehensive validation with full traceability matrix
- Complete quality architecture
- Multi-department vendor selection and management
- BLA/NDA inspection readiness; full audit program
- Everything in Growth, plus expanded quality process management
Flexible Engagements. Predictable Outcomes.
Expert guidance, purpose-built technology, and practical execution support, combined the way your stage requires.
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