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What is SimplerQMS?
                SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. 
This innovative platform ensures adherence to an array of regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others, and is fully validated under GAMP5 guidelines.
The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities.
Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel.
In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.
            
        
            What is Audit Manager?
                The Audit Manager software streamlines the quality management process by enabling digital monitoring of audits, quality controls, and assessments through every phase, from planning and checklist development to evidence gathering, field assessments, and handling nonconformities. Users can conveniently utilize the integrated calendar feature to schedule audits while including vital information like the subject matter, checklist, lead auditor, co-auditor, and participant details. The system allows both internal and external team members to receive prompt email notifications and access the audit timetable directly within the application. Once the inspection concludes, users can swiftly create audit reports in either PDF or Excel formats, making it easy to share them with company leadership or relevant stakeholders via mobile devices. Additionally, all meeting minutes are systematically archived for easy retrieval, ensuring they can be effectively incorporated into the organization’s document management systems. This efficient approach not only saves valuable time but also fosters improved communication and collaboration among all involved parties, ultimately leading to a more accountable audit process. Moreover, the software's user-friendly interface enhances the overall experience, making it accessible for all users regardless of their technical expertise.
            
        
            API Availability
            
                Has API
            
            
        
        
    
                API Availability
            
                Has API
            
            
        
        
    
                Pricing Information
        $13,750/year
        
    
    
    
        
        
            
                Free Trial Offered?
            
            
        
        
    
        
        
            
                Free Version
            
            
        
        
    
            Pricing Information
        Pricing not provided.
        
        
    
    
    
        
        
            
                Free Trial Offered?
            
            
        
        
    
        
        
            
                Free Version
            
            
        
        
    
            Supported Platforms
            
                SaaS
            
            
        
        
    
        
        
            
                Android
            
            
        
        
    
        
        
            
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                Windows
            
            
        
        
    
        
        
            
                Mac
            
            
        
        
    
        
        
            
                On-Prem
            
            
        
        
    
        
        
            
                Chromebook
            
            
        
        
    
        
        
            
                Linux
            
            
        
        
    
                Supported Platforms
            
                SaaS
            
            
        
        
    
        
        
            
                Android
            
            
        
        
    
        
        
            
                iPhone
            
            
        
        
    
        
        
            
                iPad
            
            
        
        
    
        
        
            
                Windows
            
            
        
        
    
        
        
            
                Mac
            
            
        
        
    
        
        
            
                On-Prem
            
            
        
        
    
        
        
            
                Chromebook
            
            
        
        
    
        
        
            
                Linux
            
            
        
        
    
                Customer Service / Support
            
                Standard Support
            
            
        
        
    
        
        
            
                24 Hour Support
            
            
        
        
    
        
        
            
                Web-Based Support
            
            
        
        
    
                Customer Service / Support
            
                Standard Support
            
            
        
        
    
        
        
            
                24 Hour Support
            
            
        
        
    
        
        
            
                Web-Based Support
            
            
        
        
    
                Training Options
            
                Documentation Hub
            
            
        
        
    
        
        
            
                Webinars
            
            
        
        
    
        
        
            
                Online Training
            
            
        
        
    
        
        
            
                On-Site Training
            
            
        
        
    
                Training Options
            
                Documentation Hub
            
            
        
        
    
        
        
            
                Webinars
            
            
        
        
    
        
        
            
                Online Training
            
            
        
        
    
        
        
            
                On-Site Training
            
            
        
        
    
                Company Facts
Organization Name
SimplerQMS
Date Founded
2017
Company Location
Denmark
Company Website
www.simplerqms.com
Company Facts
Organization Name
Focus Informatica
Company Location
Italy
Company Website
www.focus-auditmanager.com/software-audit-ispezioni-controlli
Categories and Features
Audit
                                        Alerts / Notifications
                                        
                                    
                                    
                                    
                                        Audit Planning
                                        
                                    
                                    
                                    
                                        Compliance Management
                                        
                                    
                                    
                                    
                                        Dashboard
                                        
                                    
                                    
                                    
                                        Exceptions Management
                                        
                                    
                                    
                                    
                                        Forms Management
                                        
                                    
                                    
                                    
                                        Issue Management
                                        
                                    
                                    
                                    
                                        Mobile Access
                                        
                                    
                                    
                                    
                                        Multi-Year Planning
                                        
                                    
                                    
                                    
                                        Risk Assessment
                                        
                                    
                                    
                                    
                                        Workflow Management
                                        
                                    
                            
                        CAPA
                                        Audit Management
                                        
                                    
                                    
                                    
                                        CAPA Planning
                                        
                                    
                                    
                                    
                                        Change Management
                                        
                                    
                                    
                                    
                                        Complaint Management
                                        
                                    
                                    
                                    
                                        Incident Management
                                        
                                    
                                    
                                    
                                        Nonconformance Tracking
                                        
                                    
                                    
                                    
                                        Quality Control
                                        
                                    
                                    
                                    
                                        Risk Management
                                        
                                    
                                    
                                    
                                        Root Cause Analysis
                                        
                                    
                                    
                                    
                                        Training Management
                                        
                                    
                            
                        Compliance
                                        Archiving & Retention
                                        
                                    
                                    
                                    
                                        Artificial Intelligence (AI)
                                        
                                    
                                    
                                    
                                        Audit Management
                                        
                                    
                                    
                                    
                                        Compliance Tracking
                                        
                                    
                                    
                                    
                                        Controls Testing
                                        
                                    
                                    
                                    
                                        Environmental Compliance
                                        
                                    
                                    
                                    
                                        FDA Compliance
                                        
                                    
                                    
                                    
                                        HIPAA Compliance
                                        
                                    
                                    
                                    
                                        ISO Compliance
                                        
                                    
                                    
                                    
                                        Incident Management
                                        
                                    
                                    
                                    
                                        OSHA Compliance
                                        
                                    
                                    
                                    
                                        Risk Management
                                        
                                    
                                    
                                    
                                        Sarbanes-Oxley Compliance
                                        
                                    
                                    
                                    
                                        Surveys & Feedback
                                        
                                    
                                    
                                    
                                        Version Control
                                        
                                    
                                    
                                    
                                        Workflow / Process Automation
                                        
                                    
                            
                        Document Control
                                        Archiving & Retention
                                        
                                    
                                    
                                    
                                        Automated Routing
                                        
                                    
                                    
                                    
                                        Change Management
                                        
                                    
                                    
                                    
                                        Compliance Management
                                        
                                    
                                    
                                    
                                        Electronic Signature
                                        
                                    
                                    
                                    
                                        Escalation Management
                                        
                                    
                                    
                                    
                                        Periodic Review
                                        
                                    
                                    
                                    
                                        Version Control
                                        
                                    
                            
                        Quality Management
                                        Audit Management
                                        
                                    
                                    
                                    
                                        Complaint Management
                                        
                                    
                                    
                                    
                                        Compliance Management
                                        
                                    
                                    
                                    
                                        Corrective and Preventive Actions (CAPA)
                                        
                                    
                                    
                                    
                                        Defect Tracking
                                        
                                    
                                    
                                    
                                        Document Control
                                        
                                    
                                    
                                    
                                        Equipment Management
                                        
                                    
                                    
                                    
                                        ISO Standards Management
                                        
                                    
                                    
                                    
                                        Maintenance Management
                                        
                                    
                                    
                                    
                                        Risk Management
                                        
                                    
                                    
                                    
                                        Supplier Quality Control
                                        
                                    
                                    
                                    
                                        Training Management
                                        
                                    
                            
                        Categories and Features
Audit
                                        Alerts / Notifications
                                        
                                    
                                    
                                    
                                        Audit Planning
                                        
                                    
                                    
                                    
                                        Compliance Management
                                        
                                    
                                    
                                    
                                        Dashboard
                                        
                                    
                                    
                                    
                                        Exceptions Management
                                        
                                    
                                    
                                    
                                        Forms Management
                                        
                                    
                                    
                                    
                                        Issue Management
                                        
                                    
                                    
                                    
                                        Mobile Access
                                        
                                    
                                    
                                    
                                        Multi-Year Planning
                                        
                                    
                                    
                                    
                                        Risk Assessment
                                        
                                    
                                    
                                    
                                        Workflow Management
                                        
                                    
                            
                        CAPA
                                        Audit Management
                                        
                                    
                                    
                                    
                                        CAPA Planning
                                        
                                    
                                    
                                    
                                        Change Management
                                        
                                    
                                    
                                    
                                        Complaint Management
                                        
                                    
                                    
                                    
                                        Incident Management
                                        
                                    
                                    
                                    
                                        Nonconformance Tracking
                                        
                                    
                                    
                                    
                                        Quality Control
                                        
                                    
                                    
                                    
                                        Risk Management
                                        
                                    
                                    
                                    
                                        Root Cause Analysis
                                        
                                    
                                    
                                    
                                        Training Management
                                        
                                    
                            
                        Compliance
                                        Archiving & Retention
                                        
                                    
                                    
                                    
                                        Artificial Intelligence (AI)
                                        
                                    
                                    
                                    
                                        Audit Management
                                        
                                    
                                    
                                    
                                        Compliance Tracking
                                        
                                    
                                    
                                    
                                        Controls Testing
                                        
                                    
                                    
                                    
                                        Environmental Compliance
                                        
                                    
                                    
                                    
                                        FDA Compliance
                                        
                                    
                                    
                                    
                                        HIPAA Compliance
                                        
                                    
                                    
                                    
                                        ISO Compliance
                                        
                                    
                                    
                                    
                                        Incident Management
                                        
                                    
                                    
                                    
                                        OSHA Compliance
                                        
                                    
                                    
                                    
                                        Risk Management
                                        
                                    
                                    
                                    
                                        Sarbanes-Oxley Compliance
                                        
                                    
                                    
                                    
                                        Surveys & Feedback
                                        
                                    
                                    
                                    
                                        Version Control
                                        
                                    
                                    
                                    
                                        Workflow / Process Automation
                                        
                                    
                            
                        EHS Management
                                        Audit Management
                                        
                                    
                                    
                                    
                                        Corrective / Preventive Actions
                                        
                                    
                                    
                                    
                                        Environmental Management
                                        
                                    
                                    
                                    
                                        Environmental Risk Assessment
                                        
                                    
                                    
                                    
                                        Forms Management
                                        
                                    
                                    
                                    
                                        Incident Management
                                        
                                    
                                    
                                    
                                        Industrial Safety Management
                                        
                                    
                                    
                                    
                                        Injury Reporting 
                                        
                                    
                                    
                                    
                                        Inspection Management
                                        
                                    
                                    
                                    
                                        MSDS
                                        
                                    
                                    
                                    
                                        OSHA Recordkeeping
                                        
                                    
                                    
                                    
                                        Occupational Health Management
                                        
                                    
                                    
                                    
                                        Safety Risk Assessment
                                        
                                    
                                    
                                    
                                        Training Management
                                        
                                    
                                    
                                    
                                        Waste Management
                                        
                                    
                            
                        Inspection
                                        Appointment Management
                                        
                                    
                                    
                                    
                                        Customer Database
                                        
                                    
                                    
                                    
                                        Dispatch Management
                                        
                                    
                                    
                                    
                                        Equipment Tracking
                                        
                                    
                                    
                                    
                                        Photos In Reports
                                        
                                    
                                    
                                    
                                        Print on Site
                                        
                                    
                                    
                                    
                                        Report Templates
                                        
                                    
                                    
                                    
                                        Speech Recognition
                                        
                                    
                                    
                                    
                                        Subcontractor Management 
                                        
                                    
                            
                        Quality Management
                                        Audit Management
                                        
                                    
                                    
                                    
                                        Complaint Management
                                        
                                    
                                    
                                    
                                        Compliance Management
                                        
                                    
                                    
                                    
                                        Corrective and Preventive Actions (CAPA)
                                        
                                    
                                    
                                    
                                        Defect Tracking
                                        
                                    
                                    
                                    
                                        Document Control
                                        
                                    
                                    
                                    
                                        Equipment Management
                                        
                                    
                                    
                                    
                                        ISO Standards Management
                                        
                                    
                                    
                                    
                                        Maintenance Management
                                        
                                    
                                    
                                    
                                        Risk Management
                                        
                                    
                                    
                                    
                                        Supplier Quality Control
                                        
                                    
                                    
                                    
                                        Training Management
                                        
                                    
                            
                        Safety Management
                                        Audit Management
                                        
                                    
                                    
                                    
                                        Corrective / Preventive Actions
                                        
                                    
                                    
                                    
                                        Incident Management
                                        
                                    
                                    
                                    
                                        Injury Reporting
                                        
                                    
                                    
                                    
                                        Inspection Management
                                        
                                    
                                    
                                    
                                        OSHA Recordkeeping
                                        
                                    
                                    
                                    
                                        Safety Risk Assessment
                                        
                                    
                                    
                                    
                                        Training Management
                                        
                                    
                            
                         
         
         
         
         
         
         
        