What HLS teams use TeamSync for.Talk to an HLS solutions engineer · Read the HLS microsite
1. PHI lifecycle controls + breach posture (HIPAA + HITECH).
Minimum-necessary access, breach analysis workflow, crypto-shred for individual rights — implemented and evidenced.
→ HLS CISO page → HIPAA overlay
2. FDA inspection readiness — continuous, not project.
Quality-system documentation continuously inspection-ready; Form 483 / Warning Letter risk reduced.
→ Chief Quality Officer (HLS) page
3. Part 11 validation evidence + signature controls.
URS / FRS / DS / IQ / OQ / PQ pack + Part 11 signature manifestations on every electronic record.
→ Validation Lead page → FDA 21 CFR Part 11 overlay
4. TMF inspection-readiness real-time.
ICH E6(R3) DIA Reference Model TMF zones with completeness rules; gaps surface as the trial runs.
5. Clinical AI defensibility for the medical board.
Per-answer evidence card with retrieved data + model + reasoning + clinician confirmation; EU AI Act + FDA SaMD aligned.
→ CMIO page → EU AI Act overlay
6. Electronic batch record reconciliation for QA release.
Master batch record vs executed batch record reconciled in real time; deviation handling integrated; release cycle compressed.
How customers buy.
Most HLS deployments enter through the Vertical-specific regulated workflow use case (the use case is starting point) or AI without leakage for clinical AI.