Fragmented Event Management
Deviations, CAPA, audit findings, change control, and complaints often live in separate tools or spreadsheets with no clean event linkage.
AI-Powered eQMS Platform
Manage every quality event in one integrated eQMS
TeraCliq eQMS unifies CAPA, deviations, change control, audits, complaints, OOS/OOT, risk assessment, supplier quality, and lab incidents into a single closed-loop quality management platform built for regulated life sciences operations.
11+Integrated QMS modules
100%21 CFR Part 11 aligned
50%Faster CAPA closure
The Problem
Why legacy quality systems fall short
Manual and fragmented quality processes create delay, poor visibility, repeated data entry, and weak evidence retrieval across the full lifecycle of quality events.
Slow Investigations and Closure
Investigations stall when ownership, approvals, evidence collection, and follow-up are managed manually across departments.
Weak Effectiveness Verification
Actions may close administratively without proving whether risk has actually been reduced or prevented from recurring.
Audit Evidence Takes Too Long
Inspection readiness suffers when teams need days to compile event history, signatures, linked documents, and training evidence.
Value Proposition
Accelerate quality and compliance across the entire lifecycle
Global Regulatory Alignment
Support GxP quality management with coverage expectations aligned to FDA, ICH Q10, ISO, EU MDR/IVDR, and WHO GMP practices.
Faster Investigation and CAPA Cycles
Reduce delays by routing quality events through structured review, action, approval, and verification steps.
Closed-Loop Effectiveness Verification
Ensure actions are not only assigned and closed, but checked for actual impact on risk reduction and recurrence prevention.
Audit-Ready Evidence in Seconds
Retrieve linked tasks, approvals, records, attachments, and history without piecing data together manually.
Deployment with practical validation discipline
- Pilot-first rollout with risk-based validation planning
- External collaboration with CDMOs, vendors, and partners
- Multi-site and multilingual alignment from day one
Integrated Modules
A unified quality event management ecosystem
CAPA
Track corrective and preventive actions from initiation through effectiveness verification.
Deviation
Capture, assess, investigate, and route deviations with clear ownership and escalation.
Change Control
Manage planned changes with impact assessment, approval logic, and linked implementation evidence.
Audit Management
Plan audits, log findings, assign actions, and maintain readiness across internal and external programs.
Complaints
Handle market or customer complaints with linked investigation, root cause, and closure records.
OOS / OOT
Structure abnormal laboratory result investigations with complete traceability and decision control.
Risk Assessment
Apply risk-based thinking consistently across event handling and decision pathways.
Supplier Quality
Extend quality collaboration to vendors, partners, and outsourced operations with structured oversight.
Lab Incidents
Manage laboratory-specific events and support cross-functional quality intelligence.
Effectiveness Checks
Demonstrate whether actions actually worked through measurable and reviewable verification.
Management Review
Aggregate trends, actions, and risk signals into executive quality oversight.
Closed-Loop Quality
From event detection to verified improvement
Raise Event
Capture deviations, complaints, incidents, or findings with complete event context.
Assess and Classify
Evaluate risk, impact, priority, and required routing with governed logic.
Investigate
Drive root cause analysis and evidence gathering across affected functions.
Assign Actions
Launch corrective and preventive actions with deadlines, approvals, and accountability.
Verify Effectiveness
Check whether actions resolved the problem and prevented recurrence.
Report and Learn
Surface trends, quality signals, and lessons learned for continuous improvement.
Real-Time Intelligence
Actionable insights for proactive quality management
Real-Time Insights
See pending tasks, event status, bottlenecks, and critical quality signals immediately.
Visual Reports
Monitor quality performance, event trends, and operational load through clear dashboards.
Trend Analysis
Identify recurring root causes, process instability, and risk concentration across units or sites.
Continuous Improvement
Convert event data into quality improvement actions instead of isolated administrative records.
Role-Based Access
Expose only relevant tasks, approvals, and information to each user group securely.
Viewing History and Traceability
Track who saw, changed, approved, and escalated each event across the workflow.
External Collaboration
Extend quality workflows beyond internal teams
Supplier and Partner Participation
Bring CDMOs, vendors, and external stakeholders into controlled quality workflows with governed access.
Linked Document and Training Actions
Drive SOP updates in DMS and retraining needs in LMS directly from quality events.
Multi-Site Standardization
Coordinate processes, approvals, and reporting across global quality organizations from a single platform.
Compliance and Control
Built for regulated digital quality operations
Electronic Signatures
All reviews, approvals, and verifications are captured online with identity-linked signatures.
Audit Trails
Every event, workflow transition, approval, edit, and system action is traceable.
Global Standards Readiness
Support regulated operations with digital controls aligned to major quality and compliance frameworks.
Configurable Workflows
Adapt workflows to site or product needs without losing standardization and governance.
Seamless Integration
Connect quality management with the wider TeraCliq ecosystem
DMS
Trigger controlled document revisions when change events or findings require updated procedures.
LMS
Assign retraining when SOPs, CAPA actions, or quality changes affect employee qualification.
LIMS
Connect abnormal laboratory results and investigation evidence to structured quality event workflows.
MES / eBMR
Link deviations, process changes, and manufacturing evidence back to operational execution.
ERP / SAP
Bridge master data, material, and enterprise process context where needed.
Legacy Systems
Extend quality control over existing tools without forcing a disruptive replacement strategy.
Measurable Impact
Business outcomes of an integrated eQMS
Faster Investigations and CAPA Closure
Reduce quality-event lead time with clear routing, ownership, and evidence control.
Audit Evidence Retrieval
Assemble event history, approvals, and linked actions quickly instead of in days.
Traceable Digital Workflow
Maintain full visibility into event progression, signatures, and verification status.
Cross-Site Quality Alignment
Standardize quality execution while preserving local visibility and controlled flexibility.
Quality Excellence
Move from fragmented quality tracking to integrated quality intelligence
TeraCliq eQMS helps regulated teams accelerate investigations, strengthen compliance, and drive measurable quality improvement from one connected platform.