Every GMP workflow. Intelligently assisted.
17 modules covering the complete pharmaceutical quality lifecycle — from issue troubleshooting to EU GMP certification.
🔍 Issue Troubleshooter
AI-powered root cause analysis for any GMP issue — OOS results, contamination events, equipment failures, deviation spikes, or audit findings. Ask in Arabic or English and get structured guidance instantly.
- Structured RCA using 5-Whys and Ishikawa frameworks
- AI-suggested probable causes ranked by likelihood
- Links to relevant SOPs and regulatory guidance
- Auto-generates deviation report draft on completion
OOS · Contamination · Deviations
⚠️ Deviation & CAPA
Complete deviation lifecycle management — log, investigate, root-cause, assign CAPA, verify effectiveness. AI guides every step and flags overdue actions before they become audit findings.
- Deviation log with severity classification (critical/major/minor)
- AI-assisted root cause investigation and CAPA suggestions
- Effectiveness verification with configurable criteria
- Auto-escalation and overdue notifications
Log · Investigate · CAPA · Verify
🔄 Change Control
GMP-compliant change management from request to implementation. AI performs impact assessment across affected documents, processes, and validation status automatically.
- Change request workflow with multi-level approval
- AI impact assessment on SOPs, validations, and specifications
- Risk scoring for each proposed change
- Links changes to affected batch records and CAPA
Request · Assess · Approve · Implement
📄 SOP Intelligence Center
Upload your existing SOPs and make them instantly searchable, queryable, and AI-assisted. Staff can ask questions in Arabic or English and get answers cited from your own documents.
- Bulk SOP upload (PDF, Word, Excel)
- AI Q&A — ask "what is the cleaning procedure for Reactor 3?" in Arabic or English
- Auto-classification by GMP category and process area
- Cross-reference detection between related SOPs
Upload · Classify · Query · Answer
🗂️ Document Library
Controlled document management with version control, expiry tracking, and distribution management. Never face an audit with an expired SOP again.
- Version-controlled document repository
- Expiry alerts 90/60/30 days before expiry
- Distribution and acknowledgement tracking
- Audit trail for every document action
Version · Expiry · Distribution
📝 GMP Template Generator
AI generates complete GMP documents from scratch — Batch Manufacturing Records, cleaning logs, calibration records, SOPs, and logbooks — tailored to your factory's specific processes.
- AI-generated BMR, BPR, cleaning validation reports
- Calibration and maintenance logbook templates
- SOP drafting with GMP-compliant structure
- Output in Arabic, English, or bilingual format
BMR · SOP · Logs · Reports
📊 Batch Record Intelligence
Digital Batch Manufacturing Records with AI-assisted release decisions. Execute batch steps digitally, capture in-process controls, and let AI flag any out-of-specification results before batch release.
- Digital BMR execution — step-by-step with e-signature
- In-process control capture with limits enforcement
- AI batch release recommendation with risk narrative
- Batch deviation auto-linkage
Execute · Control · Release
🧪 Material Management
Raw material and packaging component lifecycle — from receipt and quarantine to QC release. COA tracking, AI risk scoring per lot, and full audit trail from supplier to batch.
- Material and lot management with status tracking
- COA upload and verification
- AI lot risk score with rationale
- QC release workflow with approve/reject/conditional
Receive · Test · Release · Track
🔬 QC Laboratory Management
Instrument calibration, test method management, and OOS/OOT result handling — all with AI-assisted investigation. Never let an OOS result fall through the cracks.
- Instrument inventory with calibration scheduling
- Test method library with specification limits
- OOS/OOT result detection and AI investigation guide
- Lab data trending with anomaly detection
Instruments · Methods · OOS · Trends
✅ Audit Readiness Engine
Continuous GMP readiness scoring across all modules. Qualiva monitors your compliance posture 24/7 and surfaces critical gaps before inspectors do.
- Continuous GMP readiness score (0–100) with breakdown
- Critical gap detection with priority ranking
- AI audit preparation report on demand
- Mock inspection checklist generator
Score · Gaps · Preparation
🛡️ Risk Management (ICH Q9)
Formal risk assessment following ICH Q9 methodology. Build and maintain FMEA tables, risk registers, and AI-generated risk narratives for each manufacturing process.
- FMEA builder with severity/probability/detectability scoring
- Risk register with status tracking
- AI risk narrative generation per process
- Risk heat maps and trend reporting
FMEA · Register · Heat Maps
🔎 Self-Inspection Programme
Structured internal GMP audits with AI-generated checklists, finding management, and trend reporting. Run quarterly self-inspections that actually prepare you for regulatory visits.
- AI-generated GMP checklist by area and standard
- Finding classification (critical/major/minor/observation)
- CAPA linkage for each finding
- Trend analysis across inspection history
Checklist · Findings · CAPA · Trends
🎓 Training Management
Complete staff training lifecycle — training matrix, record keeping, competency assessment, and expiry tracking. Know exactly who is trained on what, and who is overdue.
- Training matrix by role and SOP
- Training record management with e-signature
- Competency assessment and scoring
- Overdue training alerts and escalation
Matrix · Records · Competency
📢 Complaints & Recalls
End-to-end complaint handling from receipt to closure, with full recall management capability. AI helps classify severity, suggests investigation steps, and drafts regulatory notifications.
- Complaint receipt, classification, and investigation workflow
- AI severity assessment and investigation guidance
- Recall decision support with regulatory criteria
- Regulatory notification draft generation
Receive · Investigate · Notify
🌡️ Stability Studies Intelligence
ICH Q1-compliant stability study management with full climate zone IVb support — essential for pharmaceutical manufacturers in the Middle East and North Africa. AI performs trend analysis and predicts shelf life.
- ICH Q1A–Q1F stability protocols
- Climate zone IVb conditions (30°C/65% RH, 40°C/75% RH)
- AI trend analysis and shelf life prediction
- Out-of-trend early warning before expiry
Zone IVb · Trends · Shelf Life
🤝 Supplier Quality Management
Supplier qualification, ongoing performance monitoring, and audit management. AI scores each supplier based on lot history, audit findings, and deviation links.
- Supplier qualification workflow and approval status
- AI risk score per supplier based on history
- Supplier audit scheduling and finding management
- Approved Supplier List with expiry tracking
Qualify · Audit · Score · Monitor
🇪🇺 EU GMP Pathway (Annex 11)
The only module in the Arab world purpose-built to guide pharmaceutical manufacturers through EU GMP certification — specifically Annex 11 for computerised systems. Includes a 4-phase roadmap, 14-clause checklist, and vendor validation package.
- 14-clause Annex 11 compliance checklist with gap assessment
- 4-phase EU GMP roadmap (18 months to certification)
- Vendor Validation Package: GAMP 5, IQ/OQ/PQ templates, Annex 11 matrix
- AI EU GMP gap analysis report on demand
Checklist · Roadmap · Validation