Audience
Designed for Pharmaceutical, Biotechnological, Medical Device & Cannabis manufacturers
About 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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The SBS QMS Suite of modules:
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Great product for efficient and affordable QMS Compliance
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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.
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Total Lean Management (TLM) Software
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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
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SimplerQMS
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.
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Pricing
Starting Price:
$10,000 / Annually
Pricing Details:
Starting at just 10,000$ a year
(validation included)
(validation included)
Free Trial:
Free Trial available.
Company Information
QMS for Life Sciences
Founded: 2007
United States
www.dotcompliance.com
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Product Details
Platforms Supported
Cloud
Windows
Mac
Linux
iPhone
iPad
Android
Training
Documentation
Live Online
Webinars
Videos
Support
Phone Support
Online
Dot Compliance QMS Frequently Asked Questions
Dot Compliance QMS Product 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
Change Management
Approval Workflow
Audit Trail
Change Calendar
Compliance Management
Prioritization
Release Management
Task Management
Training Management
Automated Notifications
Change Planning
Tracking & Reporting
Complaint Management
Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Survey Management
Self Service Portal
Social Media Monitoring
Compliance
Archiving & Retention
Audit Management
Compliance Tracking
Controls Testing
FDA Compliance
ISO Compliance
Incident Management
Risk Management
Surveys & Feedback
Version Control
Workflow / Process Automation
Artificial Intelligence (AI)
Environmental Compliance
HIPAA Compliance
OSHA Compliance
Sarbanes-Oxley Compliance
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Document Management
Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
File Recovery
File Type Conversion
Forms Management
Offline Access
Print Management
Version Control
Email Management
Full Text Search
Optical Character Recognition
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
Risk Management
Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment
