Pharma & Biotech

Who it’s for?

• QC/QA.
• Manufacturing/Tech Ops.
• Labs.
• PV/Complaints.
• Auditors

What it solves?

• OOS/OOT handling inconsistencies; trend blindness.
• Events & CAPAs not linked to Controlled Changes or SOP releases.
• Training not triggered by real changes.
• Approval loops and unclear external communication.

Key capabilities

• Quality Events (deviation/NCR/complaints) → investigation → QA closure.
• CAPA with action types + closure dependencies; effectiveness checks.
• Controlled Change with impact/risk and traceability matrix.
• Document Control & Training with R&U and curricula; retraining on change.
• AI summaries & suggestions.
• Preliminary Reviewer for Quality Events/CAPA/Controlled Documents/Controlled Changes.
• External Notification Recipient for partners/suppliers (read-only links) to inform relevant stakeholders in real-time and avoid external tool based communication.
• Version & audit diffs, no hard deletion + restore, configurable labels.
• Redlines, periodic review reminders.
• In-region data residency + committed uptime.

Compliance

• GxP-aligned workflows with 21 CFR Part 11–friendly e-sign, Annex 11 principles, and time-stamped audit trails.
• OOS/OOT documentation and linked chains (Event→CAPA→Change→Doc/Training) for inspection traceability.
• RBAC, retention/restore (no hard deletion), and status-based external updates with audit logs.
• Regional hosting (USA/EU/APAC/ME/ANZ) with uptime commitments.

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).
• Inspector-ready exports.
• Read-only auditor sessions.

Outcomes

• Consistent OOS/OOT.
• Faster CAPAs.
• Confident inspections.
• Training tied to change.