Dot Compliance QMSQMS for Life Sciences
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KOŚA DMSKOŚA
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Related Products
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About
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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About
KOŚA DMS is a cloud-based document management system for pharmaceutical, biotechnology, medical-device and other life-sciences organizations. It supports controlled document creation, review, approval, release, distribution and revision tracking, with workflows for SOPs, policies, forms and other quality records. Teams can manage role-based access, electronic signatures, audit trails, periodic reviews and controlled copies to maintain traceable document histories for regulated processes. Microsoft Word integration supports document drafting within familiar authoring workflows, while ERP and LIMS connections can link documentation with operational systems. The system is intended for quality assurance, quality control, regulatory affairs and document-control teams that need to coordinate document lifecycle activities across sites, functions and regulated operations.
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Platforms Supported
Windows
Supported
Mac
Supported
Linux
Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Supported
iPad
Supported
Android
Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Designed for Pharmaceutical, Biotechnological, Medical Device & Cannabis manufacturers
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Audience
Pharmaceutical manufacturers, biotechnology companies, medical device manufacturers, contract manufacturing organizations (CMOs), CDMOs, clinical research organizations (CROs), laboratories, and life sciences companies. Ideal for Quality Assurance, Quality Control, Regulatory Affairs, Compliance, and Document Control teams.
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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API
Offers API
Supported
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API
Offers API
Supported
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
$10,000 / Annually
Starting at just 10,000$ a year
(validation included)
Free Version
Not Supported
Free Trial
Supported
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Not Supported
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Training
Documentation
Supported
Webinars
Supported
Live Online
Not Supported
In Person
Supported
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Company InformationQMS for Life Sciences
Founded: 2007
United States
www.dotcompliance.com
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Company InformationKOŚA
Founded: 2025
India
kosa-ai.com/pharmaceutical-document-management-system/
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Categories |
Categories |
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Document Control Features
Archiving & Retention
Supported
Automated Routing
Supported
Change Management
Supported
Compliance Management
Supported
Electronic Signature
Supported
Escalation Management
Supported
Periodic Review
Supported
Version Control
Supported
Document Management Features
Access Controls
Supported
Archiving & Retention
Supported
Collaboration Tools
Supported
Compliance Tracking
Supported
Document Archiving
Supported
Document Assembly
Supported
Document Capture
Supported
Document Conversion
Supported
Document Delivery
Supported
Document Indexing
Supported
Document Retention
Supported
Electronic Signature
Supported
Email Management
Not Supported
File Recovery
Supported
File Type Conversion
Supported
Forms Management
Supported
Full Text Search
Not Supported
Offline Access
Supported
Optical Character Recognition
Not Supported
Print Management
Supported
Version Control
Supported
Audit Features
Alerts / Notifications
Supported
Audit Planning
Supported
Compliance Management
Supported
Dashboard
Supported
Exceptions Management
Supported
Forms Management
Supported
Issue Management
Supported
Mobile Access
Supported
Multi-Year Planning
Supported
Risk Assessment
Supported
Workflow Management
Supported
CAPA Features
Audit Management
Supported
CAPA Planning
Supported
Change Management
Supported
Complaint Management
Supported
Incident Management
Supported
Nonconformance Tracking
Supported
Quality Control
Supported
Risk Management
Supported
Root Cause Analysis
Supported
Training Management
Supported
Change Management Features
Approval Workflow
Supported
Audit Trail
Supported
Automated Notifications
Not Supported
Change Calendar
Supported
Change Planning
Not Supported
Compliance Management
Supported
Prioritization
Supported
Release Management
Supported
Task Management
Supported
Tracking & Reporting
Not Supported
Training Management
Supported
Complaint Management Features
Case Management
Supported
Complaint Classification
Supported
Corrective Actions (CAPA)
Supported
Customer Complaint Tracking
Supported
Feedback Management
Supported
Forms Management
Supported
Issue Tracking
Supported
Quality Assurance Management
Supported
Routing
Supported
Self Service Portal
Not Supported
Social Media Monitoring
Not Supported
Survey Management
Supported
Compliance Features
Archiving & Retention
Supported
Artificial Intelligence (AI)
Not Supported
Audit Management
Supported
Compliance Tracking
Supported
Controls Testing
Supported
Environmental Compliance
Not Supported
FDA Compliance
Supported
HIPAA Compliance
Not Supported
Incident Management
Supported
ISO Compliance
Supported
OSHA Compliance
Not Supported
Risk Management
Supported
Sarbanes-Oxley Compliance
Not Supported
Surveys & Feedback
Supported
Version Control
Supported
Workflow / Process Automation
Supported
Quality Management Features
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
Risk Management Features
Alerts/Notifications
Supported
Auditing
Supported
Business Process Control
Supported
Compliance Management
Supported
Corrective Actions (CAPA)
Supported
Dashboard
Supported
Exceptions Management
Supported
Internal Controls Management
Supported
IT Risk Management
Supported
Legal Risk Management
Supported
Mobile Access
Supported
Operational Risk Management
Supported
Predictive Analytics
Supported
Reputation Risk Management
Supported
Response Management
Supported
Risk Assessment
Supported
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