– AI-empowered quality for sponsor work—without chaos
– Configurable terminology, in-region hosting, and end-to-end evidence packs.
Who it’s for?
- QA/Project Quality.
- Program Managers.
- Lab/Manufacturing Leads.
- Client Partners.
What it solves?
- Scattered complaint/deviation/NCR info.
- Slow investigations & filings.
- Client-specific terminology.
- Slow sponsor visibility.
- Evidence scattered across teams/systems.
- Approval ping-pong.
Key capabilities
- In-region data residency + committed uptime.
- Quality Events & CAPA with client-specific fields/views.
- Controlled Change mapped to client requirements/validations.
- Document Control with controlled sharing; Training mapped to client SOPs.
- External Notification Recipient for partners/suppliers (read-only links) to inform relevant stakeholders in real-time and avoid external tool based communication.
- AI-empowered (assistive) summaries & suggestions.
- Preliminary Reviewer before quality item enters into workflow to avoid approval ping-pong.
- Configurable labels/roles per client; version & audit diffs; no hard deletion + restore
Compliance
- Sponsor-aware governance with status-gated external access, watermarked read-only views, and full notification audit.
- Part 11–friendly e-sign, immutable trails, retention/restore controls; RBAC to limit visibility.
- Regional hosting options to align with client contracts and data residency needs.
Audit ease
- Time-stamped, immutable audit trails with a clean, side-by-side diff so you can compare any two versions and see who changed what, when, and why.
- Read-&-Understood ledger (identity, version, meaning).
- OOS/OOT packets.
- Linked chain (Quality Event→CAPA→Controlled Change→Quality Doc/Training).
- Read-only auditor sessions.
- Client-scoped Evidence Packs (project/site/date) .
Outcomes
- Happier sponsors.
- Fewer email threads.
- Faster approvals.
- Clear accountability.
