Audience
Companies of all sizes
About MyBlueLabel
Now you have the option of your own Quality Management Expert in the shape of an online platform. Templates ready to be integrated in your company to enable smooth processes. We offer complete Quality Management Systems and online solutions for ISO 13485 Medical Devices and ISO 9001 General Quality Management.
Other Popular Alternatives & Related Software
Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health.
With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems.
What Qualio delivers:
✔️ Audit ready in weeks
✔️ Inspection ready anytime — no fire drills
✔️ Faster market entry
✔️ Lower total cost of compliance
✔️ Confident, risk-managed scaling
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isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11 and has been validated to it.
It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management.
It can be configured to meet an organization's specific needs and provides free training and free support.
It has been independently judged to provide the best customer support in its category.
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Total Lean Management (TLM) Software
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals.
TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types.
Core modules include:
• Audits
• Contact Manager (CRM)
• CAPA
• Customer Feedback
• Document Management
• Electronic Forms
• Employees
• Employee Feedback
• Equipment Calibration
• Evaluations
• FMEA
• Inspections
• Inventory/parts
• Library
• Meetings/Reviews
• Metrics
• Projects
• Purchase Orders
• Quality Record Mgt
• Rejected Materials
• Risk & Opportunities
• Sales Orders
• Strategic Planning
• Surveys
• Tasks/Events
• Training
• Work Orders
Learn more
Dot Compliance QMS
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements.
Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE!
Processes included:
▶ Document Management
▶ Training Management
▶ Quality Event Management
▶ CAPA Management
▶ Change Management
▶ Complaint Management
▶ Audit Management
▶ Supplier Quality Management
▶ Risk Management
▶ Design Control
▶ Deviations/Non-conformances
✔ Seamless Install
✔ Cost Effective
✔ One-Stop-Shop
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Pricing
Starting Price:
$235 per month
Free Version:
Free Version available.
Integrations
No integrations listed.
Company Information
MyBlueLabel
Founded: 2018
Denmark
www.mybluelabel.com
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Product Details
Platforms Supported
Cloud
Training
Documentation
Webinars
Support
Online
MyBlueLabel Frequently Asked Questions
MyBlueLabel Product Features
CAPA
CAPA Planning
Supported
Change Management
Supported
Incident Management
Supported
Quality Control
Supported
Risk Management
Supported
Root Cause Analysis
Supported
Training Management
Supported
Audit Management
Not Supported
Complaint Management
Not Supported
Nonconformance Tracking
Not Supported
Quality Management
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Supported
Maintenance Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
