The platform
The complete quality system, guided.
Qualiva is one platform that takes a factory from scattered documents to an inspection-ready QMS — organised around six pillars, every workflow intelligently assisted, all of it resolving into a single verified readiness verdict.
Document Control & SOPs
The controlled-document backbone — authoring, versioning, review, distribution, and PIN-based e-signatures, fully Annex 11 / Part 11-aligned. Generate GMP-ready SOPs, BMRs and logbooks with AI, in Arabic and English.
Pro Intelligence and above
- Controlled lifecycle from draft → review → approval → distribution → archival, with enforced version control and full revision history.
- PIN-based 3-stage e-signatures (prepare / review / approve) with role and meaning, segregation of duties, and a tamper-evident audit trail.
- Bilingual authoring — Arabic and English side by side, with AI consistency checking across related documents.
- Role-based access so the production floor only ever sees current approved versions — never superseded or draft documents.
- Automated periodic-review scheduling and full-text search across the library in both languages.
Deviations, CAPA & Change Control
Capture, investigate, and close quality events with AI-grounded root cause — and manage change with proper impact assessment. Everything links, so nothing falls through the cracks before an audit.
Pro Intelligence and above
- AI-assisted deviation classification with automatic severity grading (critical / major / minor) at point of entry, against WHO GMP and EU GMP criteria.
- Structured root-cause analysis — Ishikawa, 5-Why and fault-tree — with AI prompts that surface similar historical events to prevent recurrence.
- End-to-end CAPA lifecycle from assignment through effectiveness verification, with configurable escalation and due-date alerts.
- Change control with guided impact assessment and AI regulatory screening (EU GMP, WHO GMP, ICH Q12) before implementation.
- Cross-module linkage tying deviations and changes to SOPs, batch records, suppliers and training — full traceability context.
Audit Readiness
One continuous readiness verdict across the six GMP domains — computed by deterministic logic, never guessed — with guided gap closure, self-inspection, and inspection preparation built in.
Pro Intelligence · EU GMP gap analysis & AI Inspection Simulator on EU GMP Pathway
- A single readiness score and band, recomputed live from your own documents and operational state — the one number you defend to an inspector.
- Critical-gap detection with a prioritised remediation roadmap mapped to WHO GMP, EU GMP and the Arab GMP Code.
- Self-inspection programme with AI-generated bilingual checklists by GMP chapter, mobile finding capture, and CAPA linkage.
- EU GMP chapter-by-chapter gap assessment (Part I + Annex 11) producing a compliance-status matrix and roadmap.
- AI Inspection Simulator — a structured mock inspection that returns scored findings and an inspector-ready bilingual summary.
Batch Records & Production
From paper-on-glass to full electronic batch records, with AI-assisted review and release. Every exception is one click from a formal investigation, with the batch context already filled in.
Live Batch Execution & Digital BMR on Pro Intelligence
- Digital batch execution and AI-assisted record review with automated exception detection — specification exceedances, missing entries, calculation errors.
- Release-readiness checklist confirming QC testing, in-process controls, deviation closure and prerequisites before release is approved.
- One-click deviation launch from any batch exception, pre-populated with batch context.
- Cross-batch trend analysis surfacing process drift and yield variability across product families and lines.
- Material management and QC release workflow with COA tracking and full lot traceability.
Sterile Manufacturing
The Annex 1 (2022) suite for aseptic production — environmental monitoring intelligence, contamination control strategy, media-fill simulation, and sterile-specific validation.
Sterile Manufacturing tier
- Annex 1 (2022) compliance assessment with room-by-room scoring and a corrective-action roadmap.
- Environmental Monitoring Intelligence — trending, excursion detection, and impact assessment.
- Aseptic Process Simulation (media fill) management with structured acceptance and investigation.
- Contamination Control Strategy builder aligned to Annex 1 expectations.
- Sterile cleaning validation with MACO / limit calculations and protocol execution.
Ask Qualiva — AI guidance
An always-on GMP intelligence layer that runs through every module — interpreting your records, drafting documents, suggesting root causes, and guiding a factory from zero documentation to compliance. It interprets and guides; it never invents the verdict.
Built into every tier
- Grounded answers from your own factory records and the GMP corpus (WHO, EU GMP, ICH, Arab GMP Code, PIC/S) — source-cited regulatory interpretation, 24/7, in Arabic and English.
- AI assistance embedded in each workflow — deviation analysis, SOP drafting, risk narratives, audit responses — not a bolted-on chatbot.
- Knows your factory: on-demand entity lookup and cross-conversation recall, scoped strictly to your tenant.
- A safety-first posture — it flags a non-compliant procedure rather than silently producing one.
One verified verdict
Verified, not guessed.
Across all six pillars, every readiness figure resolves into one deterministic verdict — traceable to your own documents and operations. One number you can defend in front of an inspector, not a scatter of dashboards that disagree.
How the verdict is computed
Readiness = 60% document coverage
+ 40% operational readiness
open critical or major findings
cap the band.
See it running on your factory.
Request access and we'll set up your quality system — guided from day one.
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