QSuite - Software
QSuite is an affordable eQMS system. It is designed for small to mid sized businesses, early stage to Fortune 500 companies. It serves as a documentation control system and also has all the standard quality system modules: Training, Design Control, Supplier Control, Equipment Management, CAPA, Complaints, and more. Our standard system is designed to be flexible enough to fit most company’s structures and processes, but can also be customized to exactly fit your unique needs. We use this system daily to manage the Quality and Regulatory Systems of several companies. It has “business Friendly” designed into its coding. Let us know if you would like a demonstration.
Read more about the Features and functions of QSuite application:
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Document Control
- Document Management and Storage
- Document approval (Part 11 Compliant)
- Automated System for training management for new and updated documents
- Dashboard View with all user tasks and easy navigation to QMS elements
- Revision Control and Mgt of older versions
- Security Controls to manage which users can edit/view data/documents
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Training Management
- Automated Task and Email reminder system for all quality related tasks (reviews, approvals, trainings, etc.)
- Automated Training for Document Changes
- Training Documentation – Single place for all document storage
- Ability to add “external trainings” to system
- Tasks/reminders for upcoming and new trainings – Emails automatically generated and sent to required employees
- Verification quiz for SOP and WI Training to better assess the trainee’s degree of learning
- Integration with Thinkific to allow single place documentation of all employees’ training records
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Human Resource
- Ability to Group Users into Functional Categories
- Ability to Set User Permissions to Read/Write/Edit all QMS sections and documents
- Ability to store Job Descriptions, CVs, Performance Reviews, or any other external HR files by employee
- PIN/Password Assignments
- Management of Training Records for each employee
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Supplier Management
- Master Vendor List Electronically
- Automated Tool for Supplier Risk Assessment
- Supplier Information Storage (Address, Contact Names/numbers, Emails, and more)
- Tracks POs to Supplier
- Tracks Products and Part numbers from Suppliers
- Stores Supplier Audits and Reviews
- Stores and Tracks Supplier Corrective Actions (SCARs)
- Stores and records Supplier Incoming Receiving Inspections per product
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Purchase Order (PO) Management
- Links with Suppliers in System
- Tracks Dates and Users/Inspectors
- Creates electronic receiving inspection forms for online use
- Links to Non-Conformances as needed
- Tracks Approvals and Dates for Receiving Inspections
- Provides a link to the Receiving WI for each Order
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Facilities Management
- Stores Facility Requirements Documents
- Tracks and stores any records for facility repairs, maintenance, and pest control
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Equipment Log and Calibration Management
- Tracks all Equipment in a Facility
- Automates and sends reminder emails for Equipment due for Calibration
- Stores Calibration reports and records
- Automates and sends reminder emails for Equipment Maintenance
- Links to Process/Equipment Validation reports and protocols
- Stores and/or Links to Current Maintenance/Calibration Instructions
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Compliant Management
- Automates and Manages Complaint Reporting Process
- Sends emails to each required reviewers and approvers for each step; this helps maintain regulatory timing compliance
- Ability to store additional external documents related to the compliant
- Walks User through complaint process and steps
- Provides areas for Event Investigation and Regulatory Review
- Links to CAPA Process as needed
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Corrective Action/Preventative Action Management
- Automates and Manages CAPA Process
- Sends emails to each required reviewers and approvers for each step
- Ability to store additional external documents related to the CAPA
- Walks User through CAPA process and steps
- Provides areas for Containment, Risk Mgt Review, Verification plans, Event Investigation and Regulatory Review
- Links to NCRs, Complaints, Audits as needed
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Internal Audit Management
- Stores Internal Audit Documents
- Links/Creates CAPAs for Findings
- Ability to store additional external documents related to the Audit
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Management Review Management
- Stores Management Review Documents (Minutes, Agenda)
- Ability to store additional external documents related to the Management Review
- Summary of Action Items
- Documents Meeting attendance
- Easy to use Metric download for analysis and reports
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Non-Conformance Management
- Automates and Manages NC Process
- Sends emails to each required reviewers and approvers for each step
- Ability to store additional external documents related to the NC
- Walks User through NC process and steps
- Provides areas for Quarantine, Material Review Board, Event Investigation and Regulatory Review
- Links to POs, Products, Software, CAPAs, and SCARs as needed
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Process Validation Management
- Stores Process Validation Documents (Protocols, Reports)
- Ability to store additional external documents related to the Process Validation
- Links to Related Equipment, Products and Software
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Design Control Management
- Stores Design Control Documents (Protocols, Reports, Specs, etc)
- Ability to store additional external documents related to the Design Control
- Links to Related Equipment, Products and Software
- Electronic creation of Product and User Specifications
- Electronic creation of Risk Mgt
- Provides Traceability Matrix
- Manages Design Review Process and approvals
- Provides Electronic DMR
- Provides Electronic DHF
