Stendard SolutionStendard
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Related Products
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About
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry.
This comprehensive QMS platform helps ensure compliance with various regulatory requirements, 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, ICH Q10, and others.
The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience.
SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.
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About
We are a regulatory consultancy and technology company that helps businesses implement international standards, streamline business processes across the organization, and accelerate global growth. Our team of in-house ISO consultants can provide trusted guidance towards your management systems requirements. Given our international expertise, besides experience with companies handling hardware and software products in nature, our advisory services have proven successful for a wide variety of clients. From setting up your QMS with a complete set of documents to maintaining your QMS through proper document version control and automated workflow processes, you will find valuable features tailored to your organization, regardless of whether you are a start-up or an established organization.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Companies in the Life Science industries - Medical Device, Pharmaceutical, Biotechnology, Laboratory, and others.
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Audience
Document Generation and management platform for companies
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Version
Free Trial
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Pricing
$250 per month
Free Version
Free Trial
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Reviews/
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Reviews/
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Pros & Cons from Real UsersPros
Cons
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationSimplerQMS
Founded: 2017
Denmark
www.simplerqms.com
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Company InformationStendard
Founded: 2016
Singapore
stendard.com
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Categories |
Categories |
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Document Control Features
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Audit Features
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management
CAPA Features
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Compliance Features
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Quality Management Features
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
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Document Control Features
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Document Generation Features
Batch Processing
Collaboration
Digital Signature
Interaction Tracking
Multiple Output Formats
Templates
Document Management Features
Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control
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Integrations
Microsoft 365
Microsoft Entra ID
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