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Quality Management System (QMS)
Built-In Quality, Compliance, and
Continuous Improvement for Modern
Laboratories
Quality is not an isolated function in regulated laboratories—it is a continuous,
organization-wide responsibility. Our Quality Management System (QMS) is natively
embedded within the LIMS, ensuring that quality, compliance, and operational
execution work as one unified system.
Overview: Embedding Quality into Every Laboratory Process
Managing SOPs, deviations, CAPAs, audits, and change control manually or across disconnected systems often
leads to compliance gaps, audit stress, and operational inefficiencies. This integration enables laboratories to
maintain audit-ready operations at all times, while continuously improving processes and outcomes.
Quality events are directly linked to samples, tests, instruments, users, and workflows, providing complete traceability and context.
Standardize and control quality processes
Manage deviations, CAPAs, and non-conformances
Control SOPs and document versions
Execute internal and external audits
Manage change control systematically
Ensure continuous compliance
Key Functional Capabilities
Comprehensive quality management features for audit-ready laboratories
1
SOP & Document Management
Maintain full control over laboratory documentation.
- SOP creation and version control
- Controlled document distribution
- Effective date and expiry management
- Role-based document access
- Acknowledgement and training linkage
Benefit:
Ensures staff always follow the latest approved procedures
2
Deviation & Non-Conformance Management
Capture, investigate, and resolve quality issues effectively.
- Deviation logging from workflows, tests, or instruments
- Root cause analysis documentation
- Impact assessment
- Corrective and preventive action initiation
- Deviation trend analysis
Benefit: Enables proactive quality control and continuous improvement
3
CAPA Management
Drive corrective and preventive actions to closure.
- CAPA creation and tracking
- Assignment with due dates
- Approval workflows
- Effectiveness checks
- CAPA history and reporting
Benefit: Prevents recurrence of issues and supports continuous improvement
4
Change Control Management
Manage changes in a controlled, compliant manner.
- Change request initiation
- Impact analysis (process, test, instrument, compliance)
- Approval workflows
- Implementation tracking
- Post-change review and validation
Benefit: Ensures changes do not introduce compliance or quality risks
5
Audit Management
Stay audit-ready at all times.
- Internal and external audit planning
- Audit checklists and schedules
- Findings and observations tracking
- Evidence attachment
- Audit closure and reporting
Benefit: Reduces audit preparation time and inspection stress
6
Risk Management
Proactively identify and mitigate risks.
- Risk identification and assessment
- Risk scoring and prioritization
- Mitigation plans
- Ongoing risk monitoring
Benefit: Strengthens operational resilience and compliance posture
7
Training & Competency Management
Ensure staff are qualified and compliant.
- Training assignment based on role
- SOP-linked training records
- Competency assessments
- Training expiry alerts
Benefit: Ensures only qualified personnel perform critical tasks
Advanced QMS Capabilities
Automated quality event triggers from workflows
Cross-module quality linkage (samples, tests, instruments)
Quality trend dashboards
Regulatory inspection readiness reports
Global quality standardization across labs
Compliance & Standards Supported
Built to meet global regulatory requirements and industry standards.
GMP / GLP / GCP
ISO 17025
21 CFR Part 11
FDA & EMA Guidelines
ICH Q10 Quality Systems
ALCOA+ Data Integrity
Built-In Compliance Controls
Time-stamped audit trails
Electronic signatures
Role-based approvals
Full traceability of quality events
Business & Operational Benefits
Measurable impact across all levels of your organization.
For Laboratories
- Consistent quality execution
- Reduced deviations and rework
- Improved process discipline
For Quality & Compliance Teams
- Always audit-ready
- Simplified regulatory inspections
- Centralized quality oversight
For Management
- Visibility into quality performance
- Reduced compliance risk
- Continuous improvement culture
Why Our QMS Stands Out
Fully embedded within LIMS (not a bolt-on)
End-to-end quality traceability
Configurable workflows aligned to regulations
Scalable across global lab networks
Designed for continuous improvement
