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

Pricing

Starting Price:
$10,000 / Annually
Pricing Details:
Starting at just 10,000$ a year
(validation included)
Free Trial:
Free Trial available.

Integrations

API:
Yes, Dot Compliance QMS offers API access

Ratings/Reviews

Overall 0.0 / 5
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features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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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

Q: What kinds of users and organization types does Dot Compliance QMS work with?
Q: What languages does Dot Compliance QMS support in their product?
Q: What kind of support options does Dot Compliance QMS offer?
Q: Does Dot Compliance QMS have an API?
Q: Does Dot Compliance QMS have a mobile app?
Q: What type of training does Dot Compliance QMS provide?
Q: Does Dot Compliance QMS offer a free trial?
Q: How much does Dot Compliance QMS cost?
Q: What pricing for support is available for Dot Compliance QMS?
Q: What pricing for training is available for Dot Compliance QMS?

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

SPC

Job Management
Performance Metrics
Corrective Actions (CAPA)
OPC Data Collection
Data Linking
Real Time Data Collection
Point-of-Production Analysis
Data Entry
Excel Loader
Regulatory Compliance
Data Management