The Challenges
Life sciences organizations struggle with fragmented systems, manual processes, and disconnected data across quality, procurement, and financial operations.
Quality & Compliance Challenges
- Disconnected SOPs: SOPs remain isolated from training records and CAPA investigations, causing inconsistent application and persistent compliance gaps.
- Untraceable Audit Findings: Findings lack links to root causes, process improvements, and quality metrics, undermining operational learning and repeatability.
- Manual Inspection Prep: Readiness requires weeks of labor-intensive evidence compilation, transforming audits into costly, team-disrupting fire drills.
- Overlooked Change Impacts: Change controls ignore ripple effects on training and documentation, allowing undetected risks to build over time.
Procurement & Vendor Challenges
- Spreadsheet-Driven Selection: Selection relies on scattered spreadsheets and email chains, yielding biased decisions and suboptimal partnerships.
- Lengthy RFP Cycles: Processes extend for months with poor vendor comparisons, stalling initiatives and inflating opportunity costs.
- Buried Contract Terms: Terms are trapped in static PDFs without change tracking, inviting disputes and missed obligations.
- Disconnected Governance: Procurement functions in isolation from quality oversight, weakening accountability and exposing vulnerabilities.
Financial & Spend Challenges
- Manual Budget Reconciliations: Budget vs. actual analyses demand days of manual effort, delaying critical insights and accuracy.
- Tedious Invoice Matching: Multi-system verifications prolong workflows, breeding discrepancies and month-end bottlenecks.
- Unflagged Change Orders: Orders drive overruns without early warnings, letting costs escalate invisibly.
- Hidden Quality Impacts: Quality events' financial repercussions stay concealed until too late, magnifying leakage and shocks.
The Root Problem: Siloed Systems and Broken Traceability
In life sciences, quality, procurement, and finance are in silos—fuelled by disparate tools, manual handoffs, and inconsistent data—shatter end-to-end traceability from SOPs to vendor oversight to spend. This systemic disconnection fuels hidden risks: compliance gaps that trigger audit fire drills, procurement blind spots that inflate delays and disputes, and financial variances that silently erode capital. The result? Months of lost runway, unpredictable burn rates, and diminished credibility with regulators and investors—all while teams burn hundreds of hours on reactive reconciliations and evidence hunts, diverting focus from innovation to survival.
The Value We Provide
A unified fabric that connects every action from SOP to reconciliation, powered by accelerators and validated by human experts.
Performance Comparison
Power of One
Embedded PODs
Operational Excellence
- ✓ End-to-end traceability from SOPs to training to CAPA to spend reconciliation
- ✓ Accelerators that combines machine speed with human expertise
- ✓ Single source of truth eliminating duplicate data entry and reconciliation
- ✓ Real-time visibility into compliance status, vendor risk, and financial exposure
Business Impact
- ✓ Inspection confidence with always-ready evidence and complete audit trails
- ✓ Vendor performance improvement through risk-based oversight and scorecards
- ✓ Cost avoidance by catching variances, change orders, and overruns early
- ✓ Productivity gains freeing quality, procurement, and finance teams for strategic work
Transformation in Action
See how a mid-size biopharma can transform their quality, procurement, and financial operations with AURAGXP.
Current State: Fragmented & Manual
Quality Operations
- ✗ 4-6 weeks to prepare for FDA inspections, manually compiling evidence from 7 different systems
- ✗ CAPA investigations averaging 45 days with inconsistent root cause analysis
- ✗ Training records disconnected from SOPs, requiring manual retraining identification
Vendor Management
- ✗ 6-9 months to select and qualify new CRO vendors using spreadsheets
- ✗ Vendor audit findings tracked in SharePoint, not linked to contracts or risk scores
- ✗ No visibility into vendor performance across studies until quarterly reviews
Financial Controls
- ✗ 15-day month-end close with 60% of time spent on invoice reconciliations
- ✗ Budget variances discovered 30-45 days after change orders were approved
- ✗ No connection between quality findings (deviations, CAPAs) and financial impact
Future State: Unified & Automated
Quality Operations
- ✓ 2-3 days for inspection readiness with automated evidence linking across all quality events
- ✓ 18 days average CAPA closure with accelerator-assisted root cause analysis and HITL validation
- ✓ Training automatically triggered by SOP changes with full audit trail from document to competency
Vendor Management
- ✓ 6-8 weeks to select and qualify vendors with technology augmented RFP analysis and proposal scoring
- ✓ Audit findings auto-update vendor risk scores and trigger contract review workflows
- ✓ Real-time vendor performance dashboards with predictive risk alerts across all studies
Financial Controls
- ✓ 6-day close with three-way matching and automated variance analysis
- ✓ Budget impact alerts within 24 hours of change control approval with forecasted overruns
- ✓ Quality events (deviations, CAPAs) automatically linked to cost impact and vendor invoices
Potential Transformation Results
Expert professional services and pre-packaged solutions that work with any quality, procurement, or financial system — delivered by specialists who understand GxP compliance and operational excellence. Available through flexible service models tailored to your organization's needs.
Our Service Models
Service Model Comparison
| Service Model | Cost Savings | Flexibility | Expertise | Deployment | Ideal For |
|---|---|---|---|---|---|
| Fractional Fractional |
40-60% | Senior | 2-5 Days | Small Biopharma, Startups | |
| Dedicated Dedicated Team |
30-50% | Team | 2-4 Weeks | Mid-Large Pharma | |
| Consulting Project |
Variable | Expert | 1-2 Weeks | Specific Projects |
QPOSTM Lite
Fractional Services
Flexible, on-demand access to senior quality, procurement, and operations experts — without the overhead of full-time employees. Perfect for startups, SMBs, and project-based needs.
- Pay only for hours used — no long-term commitments
- Senior experts with 10+ years industry experience
- 2-5 day deployment — start immediately
- Scale up or down based on workload
QPOSTM Dedicated
Dedicated Teams
Build your quality, procurement, and operations teams with dedicated resources working exclusively for you — combining the flexibility of contractors with the commitment of employees.
- Dedicated team members working only on your projects
- 30-50% cost savings vs internal hires
- Full integration with your systems and processes
- Long-term relationships and knowledge retention
What We Deliver
Comprehensive services across the entire lifecycle — from strategic consulting to ongoing managed services to system implementation.
Consulting Services
Strategic advisory and assessment services to optimize your quality, procurement, and financial operations.
- Inspection Readiness Assessment — Gap analysis, mock audits, remediation planning
- Vendor Risk Assessment — Qualification strategy, due diligence frameworks, scorecard design
- Budget & Reconciliation Framework — Structure design, variance analysis, financial controls
- Process Optimization — Workflow analysis, gap identification, efficiency improvements
- Digital Transformation — Roadmap development, system selection, change management
- CAPA Strategy — Root cause methodologies, effectiveness frameworks, trending analysis
Managed Services
Ongoing operational support with accelerator-assisted validation and continuous monitoring.
- Validation Services — Computer System Validation (CSV) for 21 CFR Part 11 compliance
- CAPA & Audit Support — Investigation support, finding resolution, audit preparation
- Vendor Oversight — Performance monitoring, scorecard management, risk tracking
- Financial Reconciliation — Budget tracking, invoice validation, variance reporting
- Quality System Maintenance — SOP updates, training administration, document control
- Compliance Monitoring — Continuous oversight, regulatory tracking, risk mitigation
Implementation Services
End-to-end implementation and system integration with validation and training.
- QMS/LMS Implementation — System setup, data migration, workflow configuration
- Procurement Configuration — Vendor management setup, approval workflows, integration
- Financial Integration — Budget systems, payment workflows, reconciliation automation
- User Training — Role-based training programs, change management, adoption support
- Platform Integration — API connections, data synchronization, single sign-on
