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One Connected Operating Model. Not Six Disconnected Systems.
Our consultants and operators run it with you.
Every Tool Works. None of Them Talk.
A decade ago every device needed its own charger. Life sciences software still works that way: one system for documents, another for training, spreadsheets for vendors, a separate tool for contracts. Each fits its own slot. Nothing connects them.
AuraTrace™ is the single standard every quality, training, vendor, contract, and audit record connects to, with one audit trail across all of them.
One Record Model. One Audit Trail.
Most systems manage a single process.
AuraTrace™ manages the relationships between them, through metadata every record shares.
“Which SOP changed, who was retrained, what deviation occurred, what CAPA was implemented, what vendor was involved, what change control approved the fix, and how was effectiveness verified?”
The question every inspector eventually asks. Today the answer lives in five systems and gets rebuilt by hand, usually while the inspector waits.
Every record carries the same identifiers (vendor, document, contract, originating event), so records in one suite are already linked to the other.
Systems you keep stay where they are. AuraTrace™ holds the links and the audit trail, with no migration or re-validation.
Trace an invoice back to its source, or a deviation forward to everything it touched.
Start Where It Hurts. Keep What Works.
Every AuraTrace™ module can run natively, wrap a system you already run, or start wrapped and move to native on your schedule. No rip-and-replace.
AuraTrace™ runs the module today: full workflow, records, and signatures inside the platform.
The module stays on the system you already run and have validated. AuraTrace™ links its records into the chain without asking you to move or re-validate it.
Start wrapped, move to native when a contract renews or a system retires, without breaking traceability.
Two Connected Domains. Six Pillars. One Operating Model.
What a Connected Operating Model Delivers
Quality and Learning Management
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Explore Quality and Learning ManagementVendor Governance
Explore Vendor GovernanceOne Partner. Three Integrated Capabilities.
Most customers start with one, and each is built to lead into the next.
Design it right the first time.
- Gap assessments and QMS design
- SOP, CAPA, deviation, and audit program design
- CRO/CDMO selection, RFPs, and vendor frameworks
- FDA/EMA inspection readiness and mock inspections
Turn that design into connected, validated workflows.
- One record model and audit trail across six pillars
- Part 11 / Annex 11 e-signatures and access control
- Live vendor risk scores; AI answers that cite their sources
- MCP Connector for Microsoft Copilot and Claude
We run it with you, every day.
- Document control and training records
- CAPA, deviation, and change-control administration
- Vendor performance monitoring and QBRs
- Fractional quality and vendor leadership
Consultants design what good looks like→AuraTrace™ makes it the system of record→managed services keep it running every day. One accountable partner, with no transition gap between design and operations.
System Reads. Auditors Judge.
GxP audit programs at fixed fees. Technology pre-reads the full evidence package; qualified auditors spend their time on interviews and judgment.
One price per audit. Remote reports in five business days; hybrid and on-site in seven.
Findings, responses, and CAPAs tracked to verified closure in AuraTrace™, with evidence ready on demand.
High-risk reports reviewed by former FDA leadership; auditors matched to authority, dosage form, and language.
Build the Operating Infrastructure Your Next Stage Requires
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