qmsWrapper
4.4
47
qmsWraper is a cloud-based QMS system designed to help medical companies comply with ISO standards and FDA regulations. It includes various modules such as Document, Project, Quality, Risk, Training, CAPA, Change, Complaint, Supplier, Audit, and Nonconformity. It also offers a Traceability Matrix for DHFs, inbuilt Team Messaging, Processes, Procedure Templates, Quality Manual, Forms, and Jira integration. The pricing is affordable, starting from $165/month/25 users +1GB, and includes access to all modules and services for all users from day one, as well as lifetime in-house support. Over 800 companies have already used qmsWraper to transform their quality management systems into a collaborative and paperless environment for continual improvement.
Strengths
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User-friendly interface
Easy to navigate and use
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All-in-one solution
Includes project management, document control, and quality management
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Customizable workflows
Tailored to fit specific business needs
Weaknesses
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Limited integrations
Does not integrate with many third-party tools
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Limited reporting options
Reporting capabilities are not as robust as some competitors
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Limited mobile app functionality
Mobile app is not as comprehensive as desktop version
Opportunities
- Increased need for compliance and risk management
- Potential to integrate with more third-party tools
- Potential to improve mobile app features and usability
Threats
- Competing against larger, more established quality management software providers
- Decreased demand for quality management software due to economic factors
- Potential for data breaches and loss of customer trust
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qmsWrapper Plan
qmsWrapper offers a subscription-based pricing model with three versions (Essential, Professional, and Enterprise) starting at $49/month.
eQMS for MedDev
1
25 users Per Year
Purpose-built to facilitate compliance with standards ISO 13485, ISO 14971, 21 CFR part 11, and regulations enacted by the FDA.
Agile Project management
Comprehensive Quality Management
Document Management
In-depth Risk Management per ISO 14971
CAPA Management
Nonconformity Management
Training Management
Change Management
Complaint Management
Supplier Management
Audit Management
Report Module
Traceability Matrix with connected Risk Matrix
GAP Report Tool
Team Messaging
Quality Manual prepared per ISO 13485, editable
Form and Process Editor
More than 100 ready-made, editable Procedure Templates per ISO 13485 &14971
Ready-made process workflows defined according to the ISO and FDA requirements
Ready-made form templates
eQMS: ISO 9001
1
25 users Per Year
Purpose-built to facilitate compliance with standard ISO 9001 and regulations enacted by the FDA.
Agile Project management
Comprehensive Quality Management
Document Management
Risk Management to address risk and opportunities
CAPA Management
Nonconformity Management
Training Management
Change Management
Complaint Management
Supplier Management
Audit Management
Report Module
Traceability Matrix
GAP Report Tool
Team Messaging
Form and Process Editor
Ready-made, editable Procedure Templates per ISO 9001:2015
Ready-made workflows driven through QMS processes built according to ISO 9001:2015 requirements
Ready-made form templates
SSO Free Forever
Manage Basecamp, Smartsheet, ClickUp, Asana, Navan (Formerly TripActions), SAP Concur, Expensify, Airtable, Wrike, Microsoft Dynamics 365 with SSO
