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Driving GxP Compliance and Quality

Intrix Track streamlines quality management, enhancing productivity, reducing risks, and ensuring compliance.

Trusted by the best companies in the world

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apotex
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Quality Enchantment for Data, Compliance, and Collaboration

  • Incident management
  • Change control
  • Deviation
  • CAPA
  • Risk management
  • OOS, OOC and OOT
  • Market compliant

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).

Change control

  • Change control is a critical component of quality management systems in the pharmaceutical industry. It ensures that any changes to processes, equipment, materials, or systems are evaluated, documented, and controlled to maintain product quality and compliance with regulatory requirements.

Features

Change Request Submission

  • Standardized Forms: Use of standardized forms for submitting change requests to ensure consistency and completeness of information.
  • Identification of Change Types: Categories for changes (e.g., minor, major, emergency) to streamline the review process.
  • Generate the QC Number: Upon initial approval, a unique Quality Control (QC) number is generated for tracking purposes throughout the change control process.

Impact Assessment

  • Risk Assessment: Evaluation of potential impacts on product quality, safety, efficacy, and compliance with regulatory standards.
  • Stakeholder Involvement: Inclusion of relevant stakeholders (e.g., quality assurance, production, regulatory affairs) in the assessment process.

Documentation and Approval Process

  • Review and Approval Workflow: Clearly defined workflows for reviewing and approving changes, including timelines and responsible parties.
  • Version Control:Maintaining version history of documents to track changes and ensure access to the most current information.

Implementation Planning

  • Implementation Procedures: Detailed procedures for implementing approved changes, including timelines, resources needed, and training requirements.
  • Communication Plan: Clear communication of changes to all affected personnel to ensure understanding and compliance.

Monitoring and Verification

  • Post-Implementation Review: Assessment of the effectiveness of the change after implementation to verify that it has achieved its intended goals.
  • Quality Metrics: Monitoring of key performance indicators (KPIs) to evaluate the impact of changes on product quality and process performance.

Training and Awareness

  • Training Programs: Development of training materials and programs to ensure that staff are aware of changes and understand their implications.
  • Documentation Access: Easy access to documentation related to change control for training and reference purposes.

Historical Analysis and Trend Monitoring

  • Change History Log: Maintenance of a comprehensive log of all changes made, including details such as date, type, and reason for change.
  • Trend Analysis: Analysis of change data over time to identify recurring issues or opportunities for improvement.

Regulatory Compliance

  • Alignment with Regulations: Ensuring that the change control process complies with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ICH, ISO).
  • Audit Trails: Maintaining comprehensive records of all change control activities for regulatory inspections and internal audits.

Deviation

  • A Quality Management System (QMS) deviation typically includes features that allow organizations to track, investigate, and resolve deviations from standard operating procedures (SOPs), regulatory guidelines, or internal processes.

Features

Classification of Deviations

  • Critical, Major, Minor Categories: Categorization based on the severity of the deviation (e.g., minor, major, critical) to prioritize the response.
  • Root Cause Identification: Tools for identifying the root cause of the deviation, including dropdown menus or linked root cause analysis tools.

Workflow Management

  • Deviation Approval Process: Defined workflow for routing deviations for review, approval, and closure.
  • Escalation Protocols: Automated escalation when deviations exceed defined thresholds (e.g., unresolved for a certain time).

CAPA Integration

  • Corrective and Preventive Actions (CAPA): Link deviations to CAPA processes to ensure systematic investigation and resolution.
  • Action Plan Tracking: Monitoring and tracking of action plans tied to the deviation, with deadlines and task assignments.

Audit Trails and Traceability

  • Version Control and History: Audit trails that track all changes and updates made to the deviation report.
  • Regulatory Compliance: Built-in tools to ensure compliance with regulations like FDA 21 CFR Part 11, EU GMP, ISO standards, etc.

Risk Assessment and FMEA Integration

  • Risk Evaluation: Assess the risk impact of the deviation on product quality or patient safety.
  • FMEA (Failure Modes and Effects Analysis): Integration with FMEA to assess and mitigate risks associated with recurring or systemic deviations.

Real-Time Dashboards and Reporting

  • Visual Dashboards: Real-time status of all open and closed deviations, with KPIs for timely resolution.
  • Analytics and Trend Analysis: Reporting tools for identifying deviation trends across processes or time periods.

Notification and Alerts

  • Automated Notifications: Email or system alerts when deviations are assigned, escalated, or nearing deadlines.
  • SLA Management: Alerts tied to Service Level Agreements (SLAs) for deviation closure.

Cross-Functional Collaboration

  • Task Assignment and Collaboration: Ability to assign tasks to different team members across departments (e.g., QA, production, R&D) for cross-functional input.
  • Commenting and Documentation Upload: Space for collaboration through comments and attaching supporting documents.

Compliance and Audits

  • Audit-Ready Documentation: Comprehensive deviation records stored in a format ready for audits by internal and external parties (regulators, clients).
  • Regulatory Reporting: Automated generation of reports for regulatory submission.

CAPA

  • A CAPA (Corrective and Preventive Action) software is designed to streamline the identification, investigation, and resolution of quality issues while ensuring compliance with regulatory standards.

Features

CAPA Initiation and Reporting

  • Issue Detection and Reporting: Allows users to log CAPA cases for various triggers such as deviations, audits, customer complaints, non-conformances, or incidents.
  • Customizable Forms: Predefined and customizable templates for entering CAPA details, such as the type of issue, severity, and affected departments.

Root Cause Analysis (RCA)

  • Root Cause Investigation Tools: Built-in tools to perform root cause analysis, such as Fishbone (Ishikawa) diagrams, 5 Whys, or Fault Tree Analysis (FTA).
  • Linking to Issues: Ability to link the identified root cause to specific issues, deviations, or non-conformances within the system.

Corrective and Preventive Action Planning

  • Action Plan Creation: Generate detailed corrective and preventive action plans to address root causes, prevent recurrence, and ensure compliance.
  • Task Assignment and Tracking: Assign CAPA tasks to relevant team members, with tracking mechanisms for due dates, task completion, and status updates.

Workflow Automation and Management

  • Automated Workflows: Predefined or customizable workflows to guide the CAPA process from initiation to closure.
  • Escalation Procedures: Automated escalations based on defined triggers such as missed deadlines or unresolved critical issues.

Risk Assessment and FMEA Integration

  • Risk Evaluation Tools: Built-in risk assessment features to evaluate the impact of identified issues and CAPA effectiveness.
  • FMEA (Failure Modes and Effects Analysis): Integration with FMEA tools to assess risks associated with the identified issues and preventive measures..

CAPA Effectiveness Verification

  • Verification of Effectiveness (VoE): Tools for verifying the effectiveness of implemented corrective and preventive actions through follow-up assessments or monitoring data.
  • Continuous Monitoring: Mechanisms to track whether similar issues reoccur, ensuring the CAPA is effective in preventing recurrence.

Regulatory Compliance and Audit Trails

  • Audit-Ready Documentation: Automatically generate and store audit-ready CAPA records that meet regulatory requirements such as FDA 21 CFR Part 11, ISO 9001, and ISO 13485.
  • Audit Trails: Complete history of all changes, actions, and decisions made throughout the CAPA process, ensuring transparency and traceability.

Cross-Functional Collaboration

  • Team Collaboration: Collaboration features allowing cross-departmental teams (e.g., QA, R&D, operations) to work on CAPA resolutions, with commenting and document-sharing functionality.
  • Notifications and Alerts: Automated notifications and reminders to team members when actions are assigned, escalated, or nearing deadlines.

CAPA Reporting and Analytics

  • Customizable Reports: Generate reports on CAPA performance, including open cases, closure rates, trends, and recurring issues.
  • Dashboard Visualization: Real-time dashboards with visual analytics for tracking CAPA status, key metrics, and areas for improvement.
  • Trend Analysis: Identify patterns and trends in non-conformances, deviations, or other issues to proactively address underlying problems.

Document Control and Attachment

  • Documentation Upload: Attach supporting documents such as SOPs, test reports, risk assessments, or audit findings to CAPA cases.
  • Document Version Control: Ensure that all attached documentation is version-controlled and aligned with QMS document management protocols.

Integration with Other QMS Modules

  • Link to Deviations, Audits, and NCRs: CAPA software can be integrated with other QMS modules like deviation management, non-conformance reporting (NCR), and audit management for seamless workflows.
  • Compliance with Industry Regulations: Ensure that CAPA processes align with regulatory standards relevant to the industry, such as ISO, FDA, GMP, and ICH Q10.

Training Management

  • Training Integration: Link CAPA actions to training requirements, ensuring that employees receive relevant training when corrective actions are implemented.
  • Automated Training Assignment: Assign new or revised training to employees after implementing CAPA actions to prevent recurrence.

Mobile and Cloud Access

  • Mobile Accessibility: Access CAPA workflows and reports via mobile devices, enabling on-the-go management and updates.
  • Cloud-Based Functionality: Cloud-hosted solutions for real-time collaboration and data access from multiple locations or devices.

Data Security and Compliance

  • Access Controls and Permissions: Role-based access to ensure only authorized personnel can view, edit, or approve CAPA actions.
  • Electronic Signatures: Compliant with regulatory requirements (e.g., FDA Part 11) for secure approvals through electronic signatures.

Risk management

  • Risk management tool widely used in regulated environments like pharmaceuticals, manufacturing, and healthcare. It helps identify potential failure modes within a process, system, or design, evaluate the impact of those failures, and determine actions to mitigate risks. Intrix Track software provides for risk management, aligned with FMEA (Failure Modes and Effects Analysis)

Features

Define the Scope and System/Process

  • Users can define the process, system, or product they want to analyze within the software.
  • Intrix Track allows setting boundaries and constraints to clarify the scope of the analysis.

Assemble the FMEA Team

  • The software enables team collaboration, allowing various stakeholders with expertise to join the risk assessment process.
  • Roles and responsibilities can be assigned within the platform for effective participation.

Identify Potential Failure Modes

  • Intrix Track provides tools for brainstorming and identifying potential failure modes for different parts of the system or process.
  • It supports documentation and categorization of these failure modes for better tracking.

Identify Effects of Each Failure Mode

  • The software allows users to analyze the potential effects of each identified failure mode on the system, product, or user.
  • This step includes capturing both operational impacts and regulatory or safety concerns.

Determine the Cause of Each Failure Mode

  • Users can document and link the root causes of each failure mode.
  • The software supports analysis of multiple causes, providing insight into why failures might occur.

Assign Severity, Occurrence, and Detection Ratings

  • Intrix Track has an integrated rating system where users can assign: - Severity (S): Rate the seriousness of the failure's impact. - Occurrence (O): Rate the likelihood of the failure happening. - Detection (D): Rate the ability to detect the failure before it impacts the system or users.
  • These ratings help quantify risk for each failure mode.

Calculate the Risk Priority Number (RPN)

  • The software automatically calculates the Risk Priority Number (RPN) by multiplying the severity, occurrence, and detection ratings: RPN = S × O × D
  • This helps prioritize the most critical risks.

Prioritize Failure Modes

  • Intrix Track ranks the failure modes based on their RPN values.
  • Higher RPN values indicate higher risk, enabling teams to focus on the most pressing failure modes first.

Develop and Implement Action Plans

  • The software allows users to create action plans to mitigate identified risks.
  • It supports assigning tasks, setting deadlines, and tracking progress on the mitigation efforts.

Document Control and Attachment

  • Documentation Upload: Attach supporting documents such as SOPs, test reports, risk assessments, or audit findings to CAPA cases.
  • Document Version Control: Ensure that all attached documentation is version-controlled and aligned with QMS document management protocols.

Integration with Other QMS Modules

  • Link to Deviations, Audits, and NCRs: CAPA software can be integrated with other QMS modules like deviation management, non-conformance reporting (NCR), and audit management for seamless workflows.
  • Compliance with Industry Regulations: Ensure that CAPA processes align with regulatory standards relevant to the industry, such as ISO, FDA, GMP, and ICH Q10.

Training Management

  • Training Integration: Link CAPA actions to training requirements, ensuring that employees receive relevant training when corrective actions are implemented.
  • Automated Training Assignment: Assign new or revised training to employees after implementing CAPA actions to prevent recurrence.

Mobile and Cloud Access

  • Mobile Accessibility: Access CAPA workflows and reports via mobile devices, enabling on-the-go management and updates.
  • Cloud-Based Functionality: Cloud-hosted solutions for real-time collaboration and data access from multiple locations or devices.

Data Security and Compliance

  • Access Controls and Permissions: Role-based access to ensure only authorized personnel can view, edit, or approve CAPA actions.
  • Electronic Signatures: Compliant with regulatory requirements (e.g., FDA Part 11) for secure approvals through electronic signatures.

OOS, OOC and OOT

  • Out-of-Specification (OOS), Out-of-Trend (OOT), and Out-of-Control (OOC) events are critical aspects of quality management in regulated industries like pharmaceuticals and biotech. A QMS (Quality Management System) designed to handle these events would include specialized features to monitor, document, investigate, and resolve these issues.

Features

Event Detection and Reporting

  • Automated Data Capture: Automatically capture data from lab systems (LIMS), production equipment, or manufacturing systems to detect OOS, OOT, or OOC events in real-time.
  • Customizable Reporting Templates: Pre-defined templates for reporting OOS, OOT, or OOC events with fields such as test results, specifications, and control limits.
  • Immediate Notifications: Automated alerts and notifications to relevant personnel when an OOS, OOT, or OOC condition is detected.

Classification and Categorization

  • OOS, OOT, OOC Differentiation: Tools for differentiating between OOS (test results outside established specifications), OOT (data outside expected trend over time), and OOC (process or control charts showing deviation beyond control limits).
  • Severity and Risk Classification: Categorize events based on their severity (critical, major, minor) and potential impact on product quality or patient safety.

Investigation and Root Cause Analysis (RCA)

  • Preliminary Investigation: Initiate a preliminary investigation into OOS, OOT, or OOC events to determine if retesting or further analysis is required.
  • Root Cause Analysis Tools: Integrated RCA tools such as 5 Whys, Fishbone Diagrams, and Fault Tree Analysis to identify the root causes of the event.
  • Deeper Investigations: In cases of confirmed OOS, OOT, or OOC events, support for conducting thorough investigations including data review, retesting protocols, and operator interviews.

Deviation and CAPA Integration

  • Link to Deviation Management: If an OOS, OOT, or OOC event is confirmed, automatic linking to the deviation management process to track the issue.
  • Corrective and Preventive Actions (CAPA): Trigger CAPA processes based on investigation findings to address root causes and prevent recurrence.

Statistical Analysis and Trending

  • Statistical Process Control (SPC): Tools to monitor process stability using control charts and alerting when processes go out of control (OOC).
  • Trend Analysis: Trend monitoring for OOT events, analyzing data over time to identify shifts or drifts in processes or results before they turn into OOS events.
  • Real-Time Data Analytics: Dashboard views of current and historical performance, with the ability to detect trends or deviations early in the process.

Workflow and Task Management

  • Automated Workflows: Predefined workflows to guide users through the OOS, OOT, or OOC investigation, review, and approval process.
  • Task Assignment: Assign tasks to specific team members (e.g., lab analysts, QA, production staff) for investigation, retesting, and approval steps.
  • Deadline Management: Set deadlines for investigation and resolution, with automatic escalation if timelines are not met.

Documentation and Record Management

  • Document Control: Centralized document repository for storing all records related to OOS, OOT, or OOC investigations, including test results, investigation reports, and final conclusions.
  • Electronic Signatures: Compliant with FDA 21 CFR Part 11 for secure electronic signatures, ensuring audit readiness and regulatory compliance.

Regulatory Compliance and Audit Readiness

  • Regulatory Templates: Ensure reports and investigations meet regulatory standards such as FDA, EMA, or ICH guidelines (e.g., ICH Q7 for OOS events).
  • Audit Trails: Full audit trails capturing every action taken during the event lifecycle, ensuring traceability and accountability.
  • Validation Support: Tools for validation of lab equipment or production processes to demonstrate that OOS, OOT, or OOC events are properly managed.

Risk Assessment and FMEA Integration

  • Risk Evaluation: Risk assessment tools to evaluate the impact of the event on product quality and patient safety.
  • Failure Modes and Effects Analysis (FMEA): Integration with FMEA to identify potential failures and mitigate risks for processes showing OOS, OOT, or OOC trends.

Training and Competency Management

  • Training Requirements: Automatically trigger training for personnel when OOS, OOT, or OOC events occur to ensure staff are up-to-date on procedures and corrective actions.
  • Competency Tracking: Track employee competency and certifications related to the testing and review processes associated with OOS/OOT/OOC events.

Cross-Departmental Collaboration

  • Team Collaboration Tools: Built-in features for cross-departmental collaboration between QC, QA, manufacturing, and R&D to investigate and resolve OOS/OOT/OOC events.
  • Commenting and Document Sharing: Enable teams to collaborate by sharing documents, attaching evidence, and leaving comments on specific OOS/OOT/OOC cases.

Integration with Other Systems

  • LIMS and ERP Integration: Seamless integration with Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP), and Manufacturing Execution Systems (MES) to streamline data flow.
  • Equipment Data Integration: Directly pull data from production or laboratory equipment for automated analysis and detection of OOS/OOT/OOC events.

Customizable Reporting and Dashboards

  • Real-Time Dashboards: Visual dashboards showing key metrics such as number of OOS, OOT, and OOC events, investigation status, and root cause distribution.
  • Custom Reports: Generate custom reports for trend analysis, regulatory submission, or internal audits, focusing on OOS/OOT/OOC events and resolutions.

Data Security and Compliance

  • Access Controls and Permissions: Role-based access to ensure only authorized personnel can view, edit, or approve CAPA actions.
  • Electronic Signatures: Compliant with regulatory requirements (e.g., FDA Part 11) for secure approvals through electronic signatures.

Market compliant

  • A Quality Management System (QMS) designed to manage market complaints focuses on ensuring that customer complaints related to product quality, safety, and performance are captured, investigated, resolved, and reported in a manner that meets regulatory requirements.

Features

Complaint Intake and Logging

  • Multi-Channel Complaint Capture: Ability to log complaints from multiple sources such as email, phone, website, or social media.
  • Customizable Complaint Forms: Predefined and customizable forms for logging complaints with fields such as product details, batch/lot number, complaint category, and customer information.
  • Automated Complaint Number Generation: Unique identification numbers automatically assigned to each complaint for easy tracking.

Complaint Categorization and Classification

  • Complaint Type Classification: Classify complaints by type (e.g., quality defect, safety issue, packaging problem, delivery delay) and severity (e.g., critical, major, minor).
  • Product and Batch Identification: Capture product-specific information such as SKU, batch/lot numbers, and manufacturing date for traceability.
  • Risk-Based Categorization: Assign risk levels to complaints based on potential impact on product quality, safety, or patient health.

Workflow and Task Management

  • Automated Workflow: Predefined workflows to guide users through the complaint handling process, from intake to resolution, with automated task assignments.
  • Task Assignment and Tracking: Assign tasks to relevant teams (e.g., quality assurance, manufacturing, regulatory) for investigation, root cause analysis, and corrective actions.
  • Escalation Management: Escalate critical complaints that require immediate attention or investigation if deadlines are missed or certain thresholds are exceeded.

Root Cause Analysis (RCA)

  • Investigation Tools: Built-in tools to perform root cause analysis, such as 5 Whys, Fishbone Diagrams, and Pareto Analysis, to identify the underlying cause of the complaint.
  • Link to Product or Process Deviations: Automatically link the market complaint to related deviations, non-conformances, or internal investigations, enabling comprehensive RCA.

Corrective and Preventive Actions (CAPA)

  • CAPA Integration: Link market complaints to CAPA processes to ensure corrective actions are taken to resolve the issue and preventive measures are put in place to avoid recurrence.
  • Action Plan Management: Create and track action plans tied to complaints, with clear timelines and task assignments to relevant teams.

Regulatory Compliance and Reporting

  • Regulatory Reporting: Automatically generate reports for regulatory authorities, such as FDA, EMA, or MHRA, based on complaint severity and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485).
  • Audit Trails: Maintain comprehensive audit trails of all activities related to complaint handling, including who logged the complaint, investigation steps, actions taken, and approvals.
  • Electronic Signatures: Compliant with FDA 21 CFR Part 11 for electronic signatures to ensure secure and compliant approval workflows.

Customer Communication and Feedback

  • Automated Notifications: Send automated email or SMS updates to customers about the status of their complaint, from receipt to resolution.
  • Customer Feedback Loop: Capture customer feedback post-resolution to assess satisfaction with the complaint handling process and identify areas for improvement.

Data Analytics and Reporting

  • Customizable Dashboards: Real-time dashboards displaying key metrics, such as the number of complaints, resolution time, root cause trends, and complaint severity distribution.
  • Trend Analysis: Analyze complaint data over time to identify recurring issues, product trends, or potential areas of concern.
  • Regulatory and Management Reporting: Generate detailed reports for internal and external stakeholders, including regulatory authorities, senior management, and quality assurance teams.

Product Recall Management

  • Recall Initiation: Trigger product recalls if market complaints indicate widespread quality or safety issues. Link complaints directly to recall processes for seamless coordination.
  • Recall Tracking: Track the status of product recalls, including product retrieval, communication with regulatory bodies, and customer notifications.

Integration with Other QMS Modules

  • Integration with CAPA, Deviations, and Non-Conformance: Seamless integration with other QMS modules such as CAPA, deviation management, and non-conformance reporting, ensuring that complaints are thoroughly investigated and linked to broader quality issues.
  • ERP and CRM Integration: Integration with Enterprise Resource Planning (ERP) and Customer Relationship Management (CRM) systems to pull in product, customer, and order information for faster complaint processing.

11. Document Management and Attachments

  • Document Upload: Attach supporting documentation such as photos, test results, inspection reports, and customer correspondence to the complaint record.
  • Version Control: Ensure version control of any documents related to complaint handling, ensuring consistency and compliance with document control policies.

Mobile and Cloud Accessibility

  • Mobile Complaint Logging: Allow employees to log and track complaints via mobile devices, improving response times for field teams or remote workers.
  • • Cloud-Based Access: Cloud-hosted solutions for real-time collaboration, allowing global teams to access complaint data and take action from multiple locations.

Risk Management and FMEA Integration

  • Risk Assessment: Tools for assessing the risk of a complaint to product safety and compliance, helping prioritize investigation efforts based on potential impact.
  • FMEA (Failure Modes and Effects Analysis): Integrate with FMEA to analyze risks associated with recurring complaints and implement measures to mitigate future risks.

Training and Competency Management

  • Training Assignments: Link market complaints to employee training needs, ensuring that staff receive updated training in response to quality or safety concerns.
  • Training Tracking: Monitor the completion of training programs related to complaint resolution, product quality, and customer service.

Global Compliance and Multi-Language Support

  • Multi-Language Interface: Support for multiple languages, allowing international teams to log and manage complaints in their local language.
  • Global Regulatory Compliance: Ensure compliance with country-specific regulations, including EU, US, and other regional standards for complaint handling and reporting.

Continuous Improvement and Lessons Learned

  • Lessons Learned Database: Store outcomes and learnings from market complaints to build a knowledge base for continuous improvement and prevent recurrence of similar issues.
  • Continuous Improvement Tools: Tools for identifying improvement opportunities based on complaint trends, root causes, and product performance feedback.

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.

Frequently Asked Questions

Intrix 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.

Intrix 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.
Intrix Track allows users to identify, assess, and mitigate risks through structured tools and methodologies, ensuring compliance and safety.

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.

CAPA should be initiated for any non-conformances, significant deviations, incidents, or feedback that may impact product quality or regulatory compliance.
Users can create CAPA records, assign responsibilities, set deadlines, and monitor progress until closure, ensuring accountability and timely resolution.
Users can report incidents through the “Incident Management” module by completing a form that captures the details of the incident, including actions taken and individuals involved.
Deviations are reported through the “Deviation Management” module, where users provide details about the deviation and its impact, followed by an investigation and corrective action as needed.
Market Complaints can be logged in a dedicated module, enabling organizations to document, investigate, and resolve complaints effectively while maintaining compliance with regulatory requirements.
A Market Complaint report should include the complainant’s details, product specifics, a description of the complaint, and any relevant documentation to support the investigation.

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Intrix Docs

Manage documents and compliance with simplicity.

Intrix Talent

Effortless & cost effective solutions for your training and compliance.

Intrix Track

A complete solution for quality management.

Intrix Eye

Manage audits and compliance efficiently.

Intrix Labs

Enabling automated integration with compliance and security.

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Elevate your decorum with the precision of a digital sign.

Intrix Caliber

Maximize equipment lifecycle, efficiency and compliance.

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Simplify record-keeping with electronic logbook.

Intrix Sprint

Execute projects flawlessly, monitoring with precision.

Intrix Saga

Securely consolidate and organize archived data.

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Manage tickets and helpdesk to improve response times.

Intrix Ibook

The inventory software for store and issuance

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