Automate APQR generation, detect quality trends instantly, and maintain regulatory compliance — all powered by intelligent analytics.
Faster APQR Generation
Standard Sections
Pharma Companies
Uptime SLA
Powerful, purpose-built tools for pharmaceutical quality teams
FDA 21 CFR 211.180(e), EU GMP Chapter 1.4, and ICH Q7 compliant with full audit trail.
Automated trend analysis, Nelson rule detection, and state-of-control monitoring.
Real-time SPC with Cpk calculations and out-of-spec alerting per parameter.
One-click generation across 27 standard sections with pre-populated data.
Connect LIMS, BMR, EQMS, and ERP systems for live data synchronization.
Electronic signatures, ALCOA+ data integrity, and tamper-proof audit trails.
Get started in minutes, not months
Integrate with LIMS, BMR, EQMS, and ERP systems. Data syncs automatically in real-time.
The platform analyses trends, detects OOS/OOT results, and calculates Cpk values automatically.
One-click generation of complete APQR reports across 27 EU GMP / ICH Q7 compliant sections.
Purpose-built tools for QA managers, quality directors, and manufacturing scientists
Streamline annual reviews, maintain state of control, and prepare for regulatory inspections.
Real-time visibility into quality metrics, deviations, and CAPA effectiveness across all products.
Monitor process parameters, investigate deviations, and maintain validation status efficiently.
A modern interface designed for pharmaceutical quality teams
Every action logged with timestamps, users, and e-signatures.
Shewhart charts with Cpk & OOS alerting.
Nelson rule detection & automated trend analysis.
27 sections, one click.
LIMS, BMR, EQMS, ERP live sync.
E-signatures & ALCOA+ integrity.
OOS investigation workflows.
Real-time quality visibility.
Custom workflows for your processes.
Always inspection-ready with complete trails.
See what our customers have to say
“APQR Smart reduced our APQR preparation time from 6 weeks to 2 weeks. The AI trend analysis caught issues we would have missed.”
Sarah Chen
QA Director, PharmCorp Global
“We can now generate complete APQR reports for 50 products in a single day. The automated report generation is incredible.”
Michael Roberts
Quality Manager, MediTech Labs
“Inspection-ready at all times. The audit trail and state of control monitoring gave us complete confidence during our FDA inspection.”
Dr. Emily Watson
VP Quality, BioPharma Solutions