Electronic Quality Management System
Accelerate quality and compliance with an AI-driven, low-code platform for global regulatory readiness
AmpleLogic eQMS is an AI-driven quality management platform with 11 consolidated core modules. Built on a robust aPaaS architecture, it unifies CAPA, deviations, change control, audits, OOS/OOT, complaints, risk assessment, vendor qualification, and lab incidents into a single closed-loop system with end-to-end traceability and audit readiness.
keyFeatures
everythingYouNeed
Deviation Management
AI-driven detection and classification with structured RCA using 5-Why, Fishbone, 6M, and Fault Tree methods. Risk triage by severity and patient impact.
CAPA Management
Full lifecycle from detection through investigation, action plans, implementation, effectiveness checks, and closure with evidence capture and best practice recommendations.
Change Control
Impact assessment on quality, regulatory, and supply using recommendation engine. Approval workflows, version control, and post-change effectiveness checks.
OOS/OOT Management
Scientific phase-wise investigations (Phase 1a lab, Phase 1b manufacturing, Phase 2 extended) with automated CAPA linkage and effectiveness validation.
Complaint Handling
6-stage lifecycle integrating batch traceability, preliminary triage, RCA, CAPA implementation, retained sample review, and stakeholder feedback loop.
Audit Management
Internal, supplier, customer, and regulatory audits with planner, evidence packages, findings register, CAPA linkage, and closure verification.
Vendor Qualification
Complete supplier lifecycle from registration and qualification through monitoring, requalification, and audit integration.
Lab Incident Management
Structured scientific approach with investigation, automatic CAPA initiation, effectiveness checks, and graphical trend analysis.
Risk Assessment & QRM
Integrated quality risk management system and QRM software for pharmaceuticals β enterprise risk management with FMEA risk analysis software, drug product risk matrix software, risk scoring system, fishbone diagram analysis software, root cause analysis tools, AI risk identification software, and continuous GMP risk monitoring.
Product Recall Management
Risk-integrated recall lifecycle with multi-source trigger integration, risk-based classification, end-to-end batch traceability, and regulatory audit closure.
AI Quality Intelligence
AI-assisted root cause investigators, deviation trend prediction, change control impact analysis, and optimized action plan recommendations.
benefits
whyChoose
complianceStandards
builtForCompliance
useCases
designedForWorkflows
readyToTransform
ctaDescription
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