Comprehensive User Guide - InnoQualis EQMS

This comprehensive user guide covers all aspects of using the InnoQualis Electronic Quality Management System (EQMS), from basic user operations to advanced administrative functions. It serves as the complete reference for all user types and roles.

Last Updated: January 2025
Status: Active

Table of Contents

1. Getting Started
2. User Roles and Permissions
3. Dashboard Overview
4. Document Management
5. Training Management
6. Deviation Management
7. CAPA Management
8. Audit Management
9. Electronic Signatures
10. AI Assistant
11. Tips and Best Practices
12. Troubleshooting

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Getting Started

Accessing the System

1. Navigate to the Application: Use the URL provided by your administrator
2. Log In: Enter your username and password
3. Verify Role: Your permissions and visible features depend on your assigned role

Tip: If you cannot see a feature described in this guide, you might not have permission. Contact your administrator.

First-Time Setup

1. Complete Profile: Update your profile information
2. Review Permissions: Understand your role-based access
3. Complete Initial Training: Complete any assigned training modules
4. Explore Dashboard: Familiarize yourself with the interface

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User Roles and Permissions

Role Overview

Admin

• Full system access including user management, auditor allocation, and system configuration
• System-wide metrics and comprehensive oversight
• User and role management capabilities
• System configuration and maintenance

QA (Quality Assurance)

• Quality oversight including document approvals, deviation management, and audit findings
• Approval workflows for documents and processes
• Deviation investigation and CAPA management
• Compliance monitoring and reporting

User

• Standard user access to documents, training, deviations, and basic system features
• Personal dashboard with assigned tasks and recent activity
• Document creation and management within assigned scope
• Training completion and certification

Auditor

• External auditor access with scoped access to assigned documents
• Document review and findings submission
• Audit trail access for assigned resources
• Findings management and reporting

Permission Matrix

Feature	Admin	QA	User	Auditor
Document Management	Full Access	Approve/Review	Create/View Own	View Assigned
Training Management	Full Access	Assign/Review	Complete Assigned	View Assigned
Deviation Management	Full Access	Investigate/Resolve	Report/View Own	View Assigned
CAPA Management	Full Access	Manage/Review	View Assigned	View Assigned
Audit Management	Full Access	Manage Audits	View Own Activity	Submit Findings
User Management	Full Access	View Users	View Own Profile	View Own Profile
System Configuration	Full Access	Limited	None	None

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Dashboard Overview

The dashboard provides a comprehensive overview of your quality management activities and serves as the central hub for all operations.

My Tasks Section

Training Due

• Overdue Training: Shows training assignments that are past due
• Upcoming Training: Displays training scheduled for the next 30 days
• Completion Status: Shows progress on assigned training modules

Pending Approvals

• Document Approvals: Documents awaiting your review and approval (including workflow-based approvals)
• CAPA Approvals: Corrective and preventive actions requiring approval (including draft CAPAs)
• Deviation Approvals: Deviations awaiting approval

Open Deviations

• Active Investigations: Deviations currently under investigation
• Assigned Actions: Deviations assigned to you for action
• Overdue Items: Deviations requiring immediate attention

Active CAPA

• In Progress Actions: CAPA actions currently being implemented
• Effectiveness Reviews: CAPA actions requiring effectiveness verification
• Overdue Actions: CAPA actions past their due date

Quick Actions

Direct navigation to key modules:

• Documents: Create, view, and manage documents
• Training: Access training modules and assignments
• Deviations: Report and manage deviations
• CAPA: Manage corrective and preventive actions
• Audit: Access audit trails and findings
• Analytics: View system analytics and reports
• AI Assistant: Access AI-powered features

Recent Activity

• Audit Trail Summary: Recent system activities and changes
• Notification Center: Priority-based alerts and notifications
• System Updates: Recent system changes and announcements

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Document Management

Document Lifecycle

The document management system follows a comprehensive lifecycle from creation to obsolescence, with support for configurable workflow templates.

Document Statuses

1. Draft: Initial document creation and editing
2. In Review / In Approval: Document under review or awaiting approval from designated approvers
3. Released: Document approved and released for training
4. Effective: Document active and in use (training completed if required)
5. Superseded: Document replaced by newer version
6. Obsolete: Document retired and no longer in use

Workflow System Note: Documents using workflow templates follow workflow-defined states and transitions. Each workflow state can have different approval requirements, and the system automatically transitions documents to the next state when all approvals are collected.

Creating Documents

1. Navigate to Documents: Click "Documents" in the main navigation
2. Create New Document: Click "Upload Document" or "Create New Document" button
3. Fill Required Fields:
   • Title: Descriptive document title
   • Document Type: Select from dropdown (SOP, Work Instruction, etc.) - Required for workflow system
   • Workflow Template: Select workflow template (or use default for document type)
   • Category: Choose appropriate category
   • File: Upload the document file
   • Description: Brief description of the document
   • Keywords: Searchable keywords for the document
4. Assign Collaborators: Add reviewers and approvers (for legacy documents)
5. Save Draft: Save as draft for further editing

Workflow System: When you select a document type and workflow template, the system automatically initializes a workflow instance with the template's initial state. The document will follow the workflow-defined approval process.

Document Review Process

1. Review Assignment: Reviewers receive notification of assigned documents
2. Review Document: Access document and provide feedback
3. Add Comments: Add review comments and suggestions
4. Approve or Reject: Make approval decision with comments
5. Submit Review: Submit review for next stage

Document Approval

For Workflow-Based Documents:

1. Workflow State: Document is in a workflow state requiring your approval
2. Review Document: Access document and review content
3. Check Approval Requirements: Verify you are a required approver for the current state
4. Approve: Provide approval with electronic signature
5. Auto-Transition: System automatically transitions to next state when all approvals collected

For Legacy Documents (without workflow templates):

1. Approval Assignment: Approvers receive notification of documents ready for approval
2. Review Document: Access document and review content
3. Check Compliance: Verify document meets compliance requirements
4. Approve or Reject: Make final approval decision
5. Release Document: Release approved document for training

Document Training

1. Training Assignment: Users receive notification of new document training
2. Complete Training: Access training module and complete requirements
3. Pass Assessment: Complete any required assessments or quizzes
4. Electronic Signature: Sign training completion
5. Document Effective: Document becomes effective after training completion (if training gate enabled)

Document Search and Filtering

Search Options

• Full Text Search: Search document content and metadata
• Advanced Search: Filter by multiple criteria
• Semantic Search: AI-powered content search
• Saved Searches: Save frequently used search criteria

Filter Options

• Status: Filter by document status
• Type: Filter by document type
• Category: Filter by document category
• Date Range: Filter by creation or modification date
• Owner: Filter by document owner
• Assigned To: Filter by assigned reviewer/approver

Document Versioning

Version Control

• Automatic Versioning: New versions created on document updates
• Version History: Complete history of document changes
• Version Comparison: Compare different document versions
• Rollback Capability: Revert to previous versions if needed
• Manual Upload: Upload new versions from the Versions tab in document details

Version Management

• Superseded Versions: Previous versions marked as superseded
• Version Notes: Comments explaining version changes
• Approval Tracking: Track approvals for each version
• Training Requirements: Training requirements for each version

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Training Management

Training Program Overview

The training management system provides comprehensive training program management with group assignments, completion tracking, and electronic certifications.

Training Types

1. Document Training: Training on specific documents
2. Process Training: Training on procedures and processes
3. Compliance Training: Regulatory compliance training
4. Safety Training: Safety and security training
5. System Training: System usage and functionality training

Training Assignment

1. Group Assignment: Assign training to groups of users
2. Individual Assignment: Assign training to specific users
3. Role-Based Assignment: Assign training based on user roles
4. Scheduled Assignment: Schedule training for future dates
5. Recurring Training: Set up recurring training requirements

Training Completion

1. Access Training: Users access assigned training modules
2. Complete Content: Review training materials and content
3. Pass Assessment: Complete required assessments or quizzes (adaptive quizzes available)
4. Electronic Signature: Sign training completion
5. Certification: Receive electronic certification

Training Tracking

1. Completion Status: Track training completion status
2. Progress Monitoring: Monitor training progress
3. Overdue Tracking: Identify overdue training
4. Compliance Reporting: Generate compliance reports
5. Certification Management: Manage training certifications

Training Dashboard

My Training

• Assigned Training: Training assigned to you
• Completed Training: Training you have completed
• Overdue Training: Training past due date
• Upcoming Training: Training scheduled for the future

Training Management (QA/Admin)

• All Training: View all training assignments
• Completion Reports: Generate completion reports
• Overdue Reports: Identify overdue training
• Certification Reports: Generate certification reports

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Deviation Management

Deviation Lifecycle

The deviation management system tracks non-conformances from reporting through investigation to resolution, with support for dynamic form builders and AI-powered classification.

Deviation Statuses

1. Open: Initial deviation report
2. Under Review: Deviation under investigation
3. Actions In Progress: Corrective actions being implemented
4. Awaiting Effectiveness Check: Actions completed, awaiting verification
5. Resolved: Deviation resolved and closed
6. Approved: Final QA approval

Reporting Deviations

The system supports configurable, template-based deviation forms with sections and fields:

1. Navigate to Deviations: Click "Deviations" in main navigation
2. Report New Deviation: Click "Report Deviation" button
3. Fill Dynamic Form:
   • Basic Information Section: Title (text), Description (textarea), Severity (select with AI suggestion enabled)
   • Additional Details Section: Product Name, Lot Number, Batch Number, Impact Assessment (textarea), Customer Impact (select)
   • Related Items Section: Related Documents (document_picker - multi-select), Related CAPAs (capa_picker - multi-select)
   • Attachments Section: Images (image upload with drag-and-drop), Supporting Documents (file upload)
4. AI Classification: AI analyzes description and suggests severity with confidence score
5. Submit Report: Submit deviation for investigation

Form Builder Note: The system uses configurable form templates. The default template includes 4 sections covering all standard deviation reporting needs. Admins can create custom templates with additional sections and fields.

Deviation Investigation

1. Investigation Assignment: Investigators receive notification
2. Investigation Process: Conduct thorough investigation
3. Root Cause Analysis: Identify root cause of deviation
4. Impact Assessment: Assess impact on quality and compliance
5. Investigation Report: Document investigation findings

CAPA Creation

1. Auto-Creation: System may automatically create CAPA based on policy (e.g., 2+ related deviations)
2. Manual CAPA Creation: Create CAPA from deviation findings
3. Action Planning: Plan corrective and preventive actions
4. Implementation: Implement planned actions
5. Effectiveness Verification: Verify action effectiveness
6. Closure: Close CAPA after verification

Deviation Dashboard

My Deviations

• Reported Deviations: Deviations you have reported
• Assigned Investigations: Deviations assigned for investigation
• Open Actions: Actions assigned to you
• Overdue Items: Items requiring immediate attention

Deviation Management (QA/Admin)

• All Deviations: View all system deviations
• Investigation Reports: Generate investigation reports
• Trend Analysis: Analyze deviation trends
• Compliance Reports: Generate compliance reports

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CAPA Management

CAPA Lifecycle

The CAPA (Corrective and Preventive Action) management system manages corrective and preventive actions from planning through implementation to effectiveness verification.

CAPA Statuses

1. Draft: CAPA created without linked document (requires QA/Admin approval)
2. Open: CAPA approved and active
3. Planned: Actions planned and approved
4. In Progress: Actions being implemented
5. Completed: Actions completed
6. Effectiveness Verified: Actions verified as effective
7. Closed: CAPA closed after verification

Draft Approval Note: CAPAs without linked documents start as "draft" status and require QA Manager or Admin approval before they can be activated. Once approved, draft CAPAs transition to "open" and actions can be assigned.

CAPA Creation

1. Navigate to CAPA: Click "CAPA" in main navigation
2. Create New CAPA: Click "Create CAPA" button
3. Fill Required Fields:
   • Title: Brief description of the CAPA
   • Description: Detailed description of the issue
   • Type: Corrective or Preventive Action
   • Priority: High, Medium, Low
   • Due Date: Target completion date
   • Linked Deviations: Select related deviations (many-to-many associations supported)
4. Draft Status: If no document_id is set, CAPA starts as "draft"
5. Draft Approval: QA Manager or Admin must approve draft CAPAs
6. Assign Actions: Assign specific actions to team members (after approval)
7. Submit CAPA: Submit CAPA for approval (if draft) or activate (if approved)

Action Implementation

1. Action Assignment: Action owners receive notification
2. Implementation: Implement assigned actions
3. Progress Updates: Provide regular progress updates
4. Completion: Mark actions as completed
5. Evidence Submission: Submit evidence of completion

Effectiveness Verification

1. Verification Planning: Plan effectiveness verification
2. Verification Process: Conduct verification activities
3. Results Documentation: Document verification results
4. Effectiveness Assessment: Assess action effectiveness
5. CAPA Closure: Close CAPA if effective

CAPA Dashboard

My CAPA Actions

• Assigned Actions: Actions assigned to you
• Completed Actions: Actions you have completed
• Overdue Actions: Actions past due date
• Pending Verification: Actions awaiting verification

CAPA Management (QA/Admin)

• All CAPA: View all system CAPA (including draft CAPAs)
• Draft Approvals: Approve draft CAPAs to activate them
• Action Reports: Generate action reports
• Effectiveness Reports: Generate effectiveness reports
• Trend Analysis: Analyze CAPA trends

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Audit Management

Audit Trail

The audit management system provides comprehensive audit trails for all system activities and compliance monitoring.

Audit Trail Features

1. Comprehensive Logging: All system activities logged
2. Immutable Records: Tamper-proof audit records
3. Detailed Information: Complete activity details
4. User Attribution: Track user actions
5. Timestamp Tracking: Precise timing of activities
6. Workflow History: Complete workflow state transition history

Audit Trail Access

1. Navigate to Audit: Click "Audit Trail" in main navigation
2. View Audit Logs: Access comprehensive audit logs
3. Filter Options: Filter by user, date, action, resource
4. Search Functionality: Search audit trail content
5. Export Capability: Export audit data for analysis

Audit Trail Information

• User Information: Who performed the action
• Action Details: What action was performed
• Resource Information: What resource was affected
• Timestamp: When the action occurred
• IP Address: Where the action originated
• Additional Context: Additional relevant information
• Workflow State: For workflow-based documents, shows state transitions

Planned Audits

Audit Planning

1. Audit Creation: Create planned audits
2. Audit Scheduling: Schedule audit activities
3. Auditor Assignment: Assign auditors to audits
4. Resource Allocation: Allocate resources for audit
5. Audit Execution: Execute planned audits

Audit Findings

1. Finding Creation: Create audit findings
2. Finding Classification: Classify findings by severity
3. Finding Assignment: Assign findings for resolution
4. Resolution Tracking: Track finding resolution
5. Closure Verification: Verify finding closure

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Electronic Signatures

Electronic Signature System

The electronic signature system provides GMP-compliant electronic signatures for all critical processes and approvals.

Signature Requirements

1. Identity Verification: Verify signer identity
2. Intent Confirmation: Confirm signing intent
3. Timestamp Recording: Record precise timestamp
4. Integrity Verification: Verify signature integrity
5. Audit Trail: Complete audit trail of signatures

Signature Process

1. Signature Request: Receive signature request
2. Identity Verification: Verify your identity
3. Review Content: Review content to be signed
4. Intent Confirmation: Confirm your intent to sign
5. Signature Creation: Create electronic signature
6. Verification: Verify signature creation

Signature Verification

1. Signature Validation: Validate signature integrity
2. Identity Verification: Verify signer identity
3. Timestamp Verification: Verify signature timestamp
4. Content Verification: Verify signed content
5. Audit Trail: Complete audit trail

Signature Dashboard

My Signatures

• Pending Signatures: Signatures awaiting your action
• Completed Signatures: Signatures you have created
• Signature History: Complete signature history
• Verification Status: Signature verification status

Signature Management (QA/Admin)

• All Signatures: View all system signatures
• Verification Reports: Generate verification reports
• Compliance Reports: Generate compliance reports
• Audit Reports: Generate signature audit reports

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AI Assistant

AI-Powered Features

The AI assistant provides intelligent features for content creation, report generation, and document analysis.

AI Content Generation

1. Document Creation: AI-assisted document creation
2. Content Enhancement: Improve existing content
3. Report Generation: Generate automated reports
4. Template Creation: Create document templates
5. Content Analysis: Analyze document content

AI-Powered Search

1. Semantic Search: AI-powered content search
2. Intelligent Filtering: Smart filtering options
3. Content Recommendations: Recommend relevant content
4. Trend Analysis: Analyze content trends
5. Insight Generation: Generate content insights

AI Analytics

1. Performance Analytics: Analyze system performance
2. Compliance Analytics: Analyze compliance metrics
3. Trend Analysis: Analyze system trends
4. Predictive Analytics: Predict future trends
5. Insight Generation: Generate actionable insights

AI Severity Classification

For deviations, the AI can:

1. Analyze Description: AI analyzes deviation descriptions
2. Suggest Severity: Provides severity suggestion (Low/Medium/High/Critical)
3. Confidence Score: Shows confidence level (0-100%)
4. Rationale: Provides explanation for the suggestion
5. User Override: Users can always override AI suggestions

AI Assistant Dashboard

AI Features

• Content Generation: Access AI content generation
• Search Enhancement: Use AI-powered search
• Analytics Dashboard: View AI analytics
• Insights: Access AI-generated insights
• Recommendations: View AI recommendations

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Tips and Best Practices

User Best Practices

1. Regular Login: Log in regularly to check for updates
2. Complete Training: Complete all assigned training
3. Report Issues: Report any system issues promptly
4. Follow Procedures: Follow established procedures
5. Maintain Security: Maintain security best practices
6. Use Workflow System: Leverage workflow templates for standardized processes
7. Dynamic Forms: Use form builder templates for comprehensive deviation reporting

Administrative Best Practices

1. Regular Monitoring: Monitor system regularly
2. Backup Procedures: Follow backup procedures
3. Security Updates: Apply security updates promptly
4. User Training: Provide regular user training
5. Documentation: Maintain current documentation
6. Workflow Configuration: Configure workflow templates for common document types
7. Form Template Management: Maintain and update deviation form templates

Compliance Best Practices

1. Follow Regulations: Follow applicable regulations
2. Maintain Records: Maintain complete records
3. Audit Preparation: Prepare for audits
4. Continuous Improvement: Continuously improve processes
5. Risk Management: Manage compliance risks

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Troubleshooting

Common Issues

Login Issues

1. Forgotten Password: Use password reset functionality
2. Account Locked: Contact administrator for unlock
3. Permission Denied: Verify role and permissions
4. Session Expired: Log in again
5. Browser Issues: Clear browser cache and cookies

Document Issues

1. Upload Failures: Check file size and format
2. Permission Denied: Verify document permissions
3. Version Conflicts: Resolve version conflicts
4. Approval Delays: Check approval workflow or workflow state
5. Training Issues: Verify training requirements
6. Workflow Issues: Check workflow template configuration and state requirements

Deviation Issues

1. Form Not Loading: Verify form template is active
2. AI Classification Not Working: Check OpenAI API configuration
3. Attachment Upload Fails: Check file size and type restrictions
4. Document Picker Not Showing: Verify document permissions

CAPA Issues

1. Draft CAPA Not Appearing: Check if you have QA/Admin role for approval
2. Actions Not Assigning: Verify CAPA is approved (not draft)
3. Effectiveness Review Issues: Check action completion status

System Issues

1. Performance Issues: Check system resources
2. Connection Issues: Verify network connectivity
3. Error Messages: Check error logs
4. Feature Not Available: Verify permissions
5. Data Issues: Check data integrity

Getting Help

Support Resources

1. Documentation: Check system documentation
2. Help Desk: Contact help desk support
3. Administrator: Contact system administrator
4. Training: Access training materials
5. Community: Access user community

Escalation Procedures

1. Level 1: Basic user support
2. Level 2: Technical support
3. Level 3: System administration
4. Level 4: Vendor support
5. Emergency: Emergency procedures

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Welcome to InnoQualis EQMS! 🎉

This comprehensive user guide provides everything you need to effectively use the InnoQualis Electronic Quality Management System. Whether you're a new user learning the basics or an experienced administrator managing the system, this guide serves as your complete reference.

Remember to keep this guide updated and refer to it regularly as you work with the system. The team is committed to providing excellent support and continuously improving the system based on user feedback.

Related Documentation:

• User Actions Reference: See developer documentation for detailed role-based actions
• BDD User Journeys: See docs/user-journeys-bdd-2.md for complete workflow scenarios
• Implementation Status: See stakeholders documentation for system status