Customer references — HLS outcomes.
References organised by use case. Where named-customer references are not yet public, anonymised summaries appear with vertical sub-segment + region + scale.
For introductions, contact an HLS solutions engineer.
PHI lifecycle + HIPAA breach posture.
Reference profile: US integrated delivery network, ~12 hospitals + ~200 ambulatory sites. Outcome: PHI minimum-necessary access enforced platform-wide; breach analysis cycle from days to hours; HHS OCR follow-up resolved with cryptographic record.
FDA inspection readiness.
Reference profile: mid-size US biotech, FDA + EMA + MHRA-supervised commercial product. Outcome: continuous inspection-readiness posture replaced quarterly project; Form 483 risk reduced via real-time gap surfacing.
Part 11 validation evidence.
Reference profile: EU mid-market pharma, EMA-supervised + FDA-export. Outcome: validation pack accepted at first regulator review; signature controls passed inspection without finding.
Clinical TMF inspection-readiness.
Reference profile: CRO supporting Phase II / III trials for sponsors. Outcome: real-time TMF completeness; sponsor inspection-readiness review reduced 60% in cost.
Clinical AI defensibility.
Reference profile: academic medical centre piloting clinical-decision-support AI. Outcome: EU AI Act + FDA SaMD documentation pre-assembled; medical-board review concluded with no required changes.
Electronic batch record reconciliation.
Reference profile: CDMO serving multiple pharma sponsors. Outcome: batch release cycle from days to hours; deviation handling integrated; APR compilation effort hours not weeks.
How to use these references.
| Need | Action |
|---|---|
| Anonymised reference call | Talk to an HLS solutions engineer |
| Industry-vertical reference deck | Available under NDA |