Driving GxP Compliance and Quality
Zentixs Track streamlines quality management, enhancing productivity, reducing risks, and ensuring compliance.
Quality Enchantment for Data,
Compliance, and Collaboration
Incident management
Incident management in labs and pharmaceutical settings is crucial for ensuring safety, compliance, and operational efficiency.
Features
Categorization and Prioritization
- Incident Types: Classification of incidents (e.g., safety, equipment failure, compliance).
- Priority Levels: Ability to assign urgency and impact levels to incidents.
Workflow Automation
- Approval Processes: Automated workflows for incident review and approval.
- Task Assignment: Automatic assignment of tasks to relevant personnel based on incident type.
Investigation and Root Cause Analysis
- Utilize templates for investigation plans, assign roles and tasks to stakeholders, apply tools for identifying root causes systematically, implement the 5 Whys technique to delve deeper into issues, and use Fishbone Diagrams for visualizing potential causes.
Corrective and Preventive Actions (CAPA)
- Action Tracking: Tools for tracking the implementation of corrective and preventive actions.
- Effectiveness Review: Mechanisms to review the effectiveness of actions taken.
Compliance and Regulatory Features
- Audit Trails: Detailed logs of incident management processes for compliance audits.
- Regulatory Compliance Checklists: Built-in compliance checklists relevant to pharma regulations.
Data Analytics and Reporting
- Dashboards: Visual dashboards for monitoring incidents and trends over time.
- Custom Reports: Ability to generate custom reports for different stakeholders.
Training and Awareness
- Training Modules: Integrated training resources related to incident management.
- Training Modules: Integrated training resources related to incident management.
Integration Capabilities
- LIMS Integration: Ability to integrate with Laboratory Information Management Systems (LIMS) for seamless data flow.
- Other Systems: Integration with other enterprise systems (e.g., ERP, EHR).
Industries We Serve
Empowering diverse industries with tailored digital solutions, scalable technology, and results-driven innovation.
Pharmaceutical Companies
Biopharmaceutical Organizations
Manufacturing Plants
Clinical Research Organizations (CRO)
QA/QC Laboratories
Medical Device Companies
Analytical Laboratories
Life Sciences Organizations
Advantages of Zentixs Track
Zentixs Track streamlines quality management, enhancing productivity, reducing risks, and ensuring compliance.
Inspection Readiness at All Times
Zentixs Track keeps quality records, SOPs, CAPA documentation, and audit evidence organized, secure, and readily accessible. Comprehensive audit trails and centralized record management help maintain continuous inspection readiness.
Proactive Quality Risk Management
Identify, assess, and mitigate quality risks through structured risk assessments and real-time quality event tracking. Enable faster decision-making while reducing compliance and operational risks.
Accelerated Review and Approval Cycles
Automated workflows, electronic signatures, and configurable approval processes reduce delays and improve efficiency across quality operations while maintaining compliance.
Unified Quality Management
Manage document control, CAPA, deviations, change control, training, audits, and supplier quality within a single integrated platform, ensuring consistency across the organization.
Controlled Training and Qualification
Automate training assignments, retraining requirements, and qualification tracking to ensure employees remain competent, compliant, and audit-ready.
Built for Regulatory Compliance
Designed to support FDA 21 CFR Part 11, EU Annex 11, GMP, and ISO requirements, Zentixs Track embeds compliance controls throughout every quality process.
Achieve Compliance,
Enhance Quality, Drive Growth
Our software stands as a sentinel, guarding both product quality and process enhancements. Through its robust framework, it champions compliance with regulatory giants like US FDA and ISO 9001:2015, ensuring product strength, quality, and purity.
Guided by ICH Q10 and ISO principles, it fosters employee involvement, customer focus, and a process-oriented ethos. For organizations, it becomes the catalyst for maintaining quality control while embarking on an unwavering voyage of continuous improvement.
Empower Your Quality Journey with Integrated Solutions!
Introducing our comprehensive Quality Management Software feature, seamlessly integrating Change Control, Deviation, Risk Management, and CAPA processes. Effortlessly manage document preparation, review cycles, comment resolution, and electronic signatures within a unified platform. Maintain impeccable version control, ensuring accuracy and compliance throughout. Streamline your quality processes and elevate operational excellence with this all-encompassing software solution.
Zentixs Track in Focus
Comparing Modern QMS Capabilities
Analyze how Zentixs Track compares with Other QMS Software
| Feature | Zentixs Track | Traditional QMS Solutions |
|---|---|---|
Industry Focus | Purpose-built for Life Sciences and regulated industries | Generic platforms requiring extensive customization |
Compliance Readiness | Designed for GMP, FDA 21 CFR Part 11, EU Annex 11, and ISO requirements | Compliance often requires additional configuration and validation |
Implementation Speed | Rapid deployment with pre-configured quality workflows | Lengthy implementation and customization cycles |
User Adoption | Intuitive, role-based interface designed for quality teams | Complex interfaces leading to higher training requirements |
Integrated Quality Processes | Documents, CAPA, Deviations, Change Control, Training, Audits, and Supplier Quality in one platform | Multiple modules or third-party integrations often required |
Validation & Audit Readiness | Built-in audit trails, electronic signatures, and traceability | Audit readiness may depend on additional setup and controls |
Total Cost of Ownership | Lower operational overhead with a unified platform | Higher costs due to customization, maintenance, and integrations |
Compliance Support
Streamlining regulatory processes with reliable, secure, and efficient compliance management solutions.
21 CFR Part 11
Support compliant electronic records with secure audit trails.
EU Annex 11
Enable validated computerized systems with data integrity.
GxP Guidelines
Align quality processes with global regulatory requirements.
GMP Support
Digitize manufacturing workflows with controlled documentation.
GLP Standard
Support laboratory compliance with reliable data management.
GCP Protocol
Facilitate compliant clinical documentation and process management.
ALCOA+ Principles
Promote data integrity with accurate complete digital records.
ICH Q10 Framework
Support operational quality systems with standardized processes.
Seamless Product Integrations
Connect Track with the entire Zentixs ecosystem
Seamless Product Integrations
Connect Track with the entire Zentixs ecosystem
Frequently Asked Questions
Zentixs Track is a Quality Management System (QMS) software designed to facilitate change control, CAPA management, deviation, incident reporting, risk management, and market complaint handling in regulated industries.
Zentixs Track is suitable for organizations in regulated sectors, including pharmaceuticals, healthcare, and manufacturing, where quality management and compliance are essential.
- Comprehensive risk management tools (FMEA).
- Change Control for managing modifications to processes.
- CAPA management for tracking corrective and preventive actions.
- Incident Management for reporting and resolving incidents.
- Market Complaint handling for efficient resolution of customer complaints.
- Deviation Management for logging and investigating deviations.
- Out of Specification (OOS) management for handling OOS results.
- Out of Trend (OOT) and Out of Trend Category (OOTC) analysis for trend monitoring.
Users can initiate a Change Control request by accessing the "Change Control" module, completing the request form, and submitting it for evaluation by stakeholders.
All changes go through a systematic review process, including impact assessments and approvals, which are logged in the system for transparency and traceability.
