QUALITY AND LEARNING + VENDOR GOVERNANCE + TRACEABILITY = GREATER OPERATIONAL CONTROL

Life Sciences organizations waste thousands of hours every year because critical data lives in separate systems.
At AuraGxP, we unify all these entities under one traceability umbrella - so you always know what's happening and why.

Two Operational Domains. Six Pillars. One Connected Model.

AuraGxP brings Quality and Learning Management together with Vendor Governance, connecting the documentation, decisions, evidence, risk, and performance behind regulated operations.

The result is stronger control, clearer accountability, and fewer gaps between teams and systems.
2
Operational Domains
6
Connected Pillars
1
Traceable Record
Why we built AuraTrace™

Built From Real-World Experience

AuraGxP helps replace this fragmentation
with one connected operating model.

AuraGxP was built to solve these problems.

Our team has spent decades working inside life sciences organizations and managing the challenges created by disconnected processes.
We have seen companies add systems and senior resources without the right operational foundation in place. The result was often unnecessary complexity, duplicated technology, and expensive manual work.
Life sciences organizations often manage quality records, vendor information, contracts, project milestones, & vendor performance data across disconnected systems and/or spreadsheets.
Duplicated work
Manual reconciliation
Inconsistent records
Undocumented decisions
Delayed decisions
Limited visibility into risk and spend
Our Mission

AuraGxP exists because life sciences companies run on a web of vendors, quality obligations, and spend decisions that shape one another, yet the systems used to manage them rarely work together. That fragmentation creates manual effort and hides the real relationship between quality, performance and cost.

Our mission is to unify these functions into one common framework, giving life sciences organizations the infrastructure to see how quality and performance drive cost, so teams can focus on outcomes instead of coordination.

Our Vision

We are driven by a deep respect for the complexity of clinical trials, and the responsibility that comes with improving them.

We believe systems should bring clarity, not confusion, and that every workflow should be designed around real-world operational needs. We value precision, accountability, and long-term thinking over shortcuts or temporary fixes.

Most importantly, our vision is guided by the understanding that our offerings should optimize outcomes for our customers who bring life-changing treatments to the world.

DNA double helix
Company

Where We Are

San FranciscoSan DiegoBostonBangalore, India

Delivering globally

Bangalore
India
San Francisco
United States
San Diego
United States
Boston
United States
Two Domains

Connected Through Traceability

Quality management and vendor operations should not function as separate systems.
Quality and Learning Management Suite
Complete quality management. From document control to inspection evidence.
Vendor Governance Suite
From vendor selection to live risk scoring. One connected record.
Traceability Layer

AuraGxP connects quality events, vendor performance, contractual obligations, milestones, and spend so teams can understand:

Which vendors are creating the greatest quality or delivery risk.
How quality events affect timelines and costs.
Whether invoices align with contracts and completed milestones.
Which decisions, actions, and records sit upstream or downstream of an issue.
Capability Matrix

Every Service Maps to the Same Six Pillars

One structure across our platform, consulting, and managed services, so nothing gets lost at a handoff.

DomainPillarConsultingAuraTrace™ PlatformManaged ServicesReporting
Quality and LearningQuality Compliance
  • SOP development
  • Training program design
  • Quality agreement drafting
  • Document management
  • Learning management
  • Document control specialist
  • Training curriculum and record management
Cross Domain and Cross Pillar Reports and Dashboards
Quality Assurance
  • Gap assessments
  • Process development
  • Change control
  • CAPA, deviation, risk, and complaints management
  • Quality events
  • QMS process management
  • Targeted project support
Inspection Readiness
  • Audit program design
  • GxP audits and mock inspections
  • Audit management
  • Annual audit planner
  • Role-based audit room
  • Continuous inspection readiness support
Vendor GovernanceContract and Budget Management
  • Contract and SOW review
  • Contract lifecycle management
  • Change order management
  • Order tracking
  • Spend reconciliation
  • Change order and scope creep monitoring
Vendor Management
  • Vendor selection and RFP process management
  • Vendor governance strategy
  • Vendor onboarding
  • Vendor selection
  • KPI management
  • Vendor compliance tracking
  • Vendor issue escalation and resolution management
Sponsor Oversight
  • Vendor oversight framework design
  • Delivery feedback
  • Vendor risk scoring
  • Benchmarking
  • Governance meeting management
  • Vendor performance monitoring
  • Quarterly business review facilitation

Start Where You Need Us. Use What You Need.

Start with one urgent need and expand into a connected operating model as your organization grows.