Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
SmartISO

SmartISO

ODACITY LLC
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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

About

SmartISO is a cloud-based compliance and quality management platform for organizations managing ISO systems internally. It brings document control, internal audits, corrective and preventive actions (CAPA), risk management, training records, management review, supplier evaluation, and quality dashboards into one workspace. Teams can coordinate quality, environmental, and occupational health and safety activities, with workflows aligned to ISO requirements. AI-assisted features support document drafting and analysis, with generated content available for user review. SmartISO is intended for quality and HSE managers, compliance teams, and ISO consultants at small and mid-sized organizations. Plans vary by standards, storage, AI allowances, and other included features; a 14-day free trial is available.

Platforms Supported

Windows Supported
Mac Supported
Linux Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported

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

Audience

Designed for Pharmaceutical, Biotechnological, Medical Device & Cannabis manufacturers

Audience

Quality managers, HSE managers, compliance officers and ISO consultants at small and mid-sized organizations

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

API

Offers API Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

No images available

Pricing

$10,000 / Annually
Starting at just 10,000$ a year
(validation included)
Free Version Not Supported
Free Trial Supported

Pricing

$39/month/user
Starter is $39 per user per month and includes ISO 9001, 5 GB storage, 50 AI calls per month, 10 client portal users, 2 external auditors, and email support. The site advertises 20% savings on annual billing. Professional is $79/user/month; Business is $119/user/month. All plans include a 14-day free trial; no credit card is required to start.
Free Version Not Supported
Free Trial Supported

Reviews/Ratings

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

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Reviews/Ratings

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

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Company Information

QMS for Life Sciences
Founded: 2007
United States
www.dotcompliance.com

Company Information

ODACITY LLC
Founded: 2024
United States
smartiso.io/

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Categories

Categories

ISO Compliance 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

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

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

Integrations

Salesforce Supported

Integrations

Salesforce Not Supported
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Claim Dot Compliance QMS and update features and information
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