Quality Management System
Industry-agnostic quality management system for investigations, quality documentation & quality processes within a single 21 CFR Part 11 compliant platform.
One Platform for
All Quality Documentation
Professional Document Creation
Create, edit, and format SOPs, protocols, and quality documents using advanced authoring tools and standardized templates.
Version Control & Document Release
Maintain complete version history and release management to ensure only current, approved documents are accessible across sites.
Bulk Import & Auto-Capture
Migrate legacy SOPs and records through drag-and-drop, email upload, or monitored folders with automatic metadata tagging.
Your All-in-One System for Controlled Quality Management
Bring investigations, CAPA, deviations, audits, and quality documentation together within one connected system using Qualis QMS Replace disconnected quality processes with a structured solution built for consistency, accountability, collaboration, and operational control.
Coordinate quality activities, streamline approvals, and manage records, workflows, and compliance processes more efficiently across the organization.
Global Oversight
Maintain standardized quality management across multiple global sites.
Traceable Processes
Track investigations, deviations, CAPAs, and approvals with full audit history.
Role-Based Access Control
Control user permissions and approvals to secure quality processes and records.
Centralized Workspace
Manage investigations, CAPAs, SOPs, audits, and quality records in one secure workspace.
Structured Quality Workflows
Standardize investigations, reviews, approvals, and CAPAs with automated routing.
Global Oversight
Maintain standardized quality management across multiple global sites.
Traceable Processes
Track investigations, deviations, CAPAs, and approvals with full audit history.
Role-Based Access Control
Control user permissions and approvals to secure quality processes and records.
Centralized Workspace
Manage investigations, CAPAs, SOPs, audits, and quality records in one secure workspace.
Structured Quality Workflows
Standardize investigations, reviews, approvals, and CAPAs with automated routing.
Manage Every
Critical Quality Process From Start to Finish
Non-Conformance Management
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Deviation & OOS Logging
Capture incidents and Out-of-Specification results through configurable forms with automatic unique ID assignments.
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Structured Investigation Workflows
Route investigations through predefined review paths with automated task allocation and clearly assigned investigation leads.
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CAPA Linkage & Traceability
Connect investigations directly to corrective and preventive actions with complete audit trails from detection to closure.
Discuss Your Quality Workflow
Risk Management
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Risk Assessments
Perform FMEA-based evaluations to assess severity, occurrence, and detectability of deviations or proposed changes.
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Risk-Driven Escalation Controls
Automatically trigger additional review layers and approvals when predefined risk thresholds are exceeded.
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Documented Risk History
Maintain complete records of risk evaluations and mitigation actions for inspection-ready quality control.
Download QMS Brochure
Change Management
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Change Request Initiation
Initiate change requests directly from investigations or audit findings and route them through role-based approval workflows.
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Impact & Compliance Assessment
Evaluate operational, regulatory, and risk implications before approval of process, equipment, or system modifications.
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Controlled Review & Release
Manage approvals with electronic signatures and ensure only formally approved changes are implemented.
See QMS in Action
Controlled Review Lifecycle
Manage CAPA activities from initiation through execution, verification, and closure with controlled review, approval, and release workflows that ensure compliance and accountability.
Vendor & Supplier Qualification
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Supplier Qualification Records
Maintain structured supplier profiles with controlled approval tracking and documentation.
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Linked Vendor Investigations
Connect supplier-related deviations and audit findings directly to quality records for accountability.
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Performance Trend Monitoring
Monitor supplier performance trends to proactively identify risks and maintain ongoing compliance.
Download QMS Brochure
Resource & Training Management
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Competency & Certification Tracking
Track employee competencies, certifications, and training records aligned to job roles and responsibilities.
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Automated Retraining Assignment
Trigger retraining automatically when SOPs are updated, deviations occur, or process changes are approved.
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Inspection-Ready Training Records
Maintain complete, secure training documentation to show workforce compliance during regulatory inspections.
Book a personalized Demo
Audit Management
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Audit Scheduling & Planning
Manage internal and external audits across departments and sites within a standardized tracking system.
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Audit Findings Tracking
Document audit findings in structured logs and link observations directly to investigations, change records, or corrective actions.
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Timely Response & Closure Monitoring
Track corrective responses with automated alerts to ensure findings are addressed and formally closed on time.
Connect With a Quality Expert
Secure Repository for
Quality Documentation
Centralized Workspace
Organize documents and records within hierarchical workspaces aligned to departments, sites, or quality functions.
Smart Search & Metadata Filtering
Locate any record instantly using full-text search and dynamic metadata filters.
Case Closure & Secure Archival
Formally close records and safely store them within a compliant quality system.
See How QMS Fits You
Centralized Workspace
Organize documents and records within hierarchical workspaces aligned to departments, sites, or quality functions.
Smart Search & Metadata Filtering
Locate any record instantly using full-text search and dynamic metadata filters.
Case Closure & Secure Archival
Formally close records and safely store them within a compliant quality system.
Built for
Global Regulatory Compliance
Electronic Records & E-Signatures
Aligned with 21 CFR Part 11, Annex 11, GLP, GAMP 5, and ALCOA+ principles.
Comprehensive Audit Trails
Automatic capture of every action with date and time stamps.
Role & Site-Based Access Control
Granular permissions with logical segregation of data.
Version & Release Management
Maintain complete version history and ensure only effective versions are available.
Configurable Password Policies
Enterprise-grade authentication and security rules.
Benefits of Switching to Qualis QMS
Centralized Quality Hub
Integrate all your quality documents and investigations in a single, organized workspace.
Automated Workflows
Streamline tasks with rule-driven routing and event-triggered actions
Audit-Ready
Every action tracked and every version saved,always ready for inspection
Effortless Access
Instantly locate records and stay updated with real-time notifications.
Would you like to learn more about Qualis QMS?
Submit this form and our sales representative will contact you soon. E-Mail us: sales@agaramtech.com
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