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Description

Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance solution includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured processes, enabling customers to deploy quickly and cost effectively. Dot Compliance ready to use solutions include full project validation services and product validation packages. Dot Compliance offers the industry’s most cost-effective quality and compliance management solution available, allowing users to quickly deploy flexible and scalable solutions. Automate core quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, Supplier Quality, and more. Our solution is fully configurable and offers seamless integration abilities, with easy adaptation and implementation of customer’s specific requirements.

Description

Our Quality Management System (QMS) encompasses comprehensive modules that cover every phase of the product life cycle, ranging from Design Control to Corrective and Preventive Actions (CAPA). We empower your entire workforce through training and are ready to assist you whenever necessary. Enzyme Consulting, LLC. specializes in tailoring and implementing your Quality System to meet your specific needs. Once you complete your onboarding process, our team remains accessible for follow-up discussions and to address any inquiries you may have. Created by seasoned industry professionals who were disillusioned with current QMS options, Enzyme's system is specifically designed for life science companies, with a strong focus on the unique hurdles of developing FDA-regulated software. With the support of our committed consultants, you can bring your product to market with assurance. Our consultants possess not only direct experience in the medical device sector but also a keen ability to evaluate risks accurately, allowing them to truly understand and relate to the challenges faced during the product development journey. This level of support ensures that you are not alone in navigating these complexities.

API Access

Has API Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

GitHub No 
Jenkins No 
Jira No 
Salesforce Yes 

Integrations

GitHub Yes 
Jenkins Yes 
Jira Yes 
Salesforce No 

Pricing Details

$10,000 / Annually
Starting at just 10,000$ a year
(validation included)
Free Trial Yes 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
Mac Yes 
Linux Yes 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

QMS for Life Sciences

Founded

2007

Country

United States

Website

www.dotcompliance.com

Vendor Details

Company Name

Enzyme

Founded

2016

Country

United States

Website

www.enzyme.com

Product Features

Audit

Alerts / Notifications Yes 
Audit Planning Yes 
Compliance Management Yes 
Dashboard Yes 
Exceptions Management Yes 
Forms Management Yes 
Issue Management Yes 
Mobile Access Yes 
Multi-Year Planning Yes 
Risk Assessment Yes 
Workflow Management Yes 

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

Change Management

Approval Workflow Yes 
Audit Trail Yes 
Automated Notifications No 
Change Calendar Yes 
Change Planning No 
Compliance Management Yes 
Prioritization Yes 
Release Management Yes 
Task Management Yes 
Tracking & Reporting No 
Training Management Yes 

Complaint Management

Case Management Yes 
Complaint Classification Yes 
Corrective Actions (CAPA) Yes 
Customer Complaint Tracking Yes 
Feedback Management Yes 
Forms Management Yes 
Issue Tracking Yes 
Quality Assurance Management Yes 
Routing Yes 
Self Service Portal No 
Social Media Monitoring No 
Survey Management Yes 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing Yes 
Environmental Compliance No 
FDA Compliance Yes 
HIPAA Compliance No 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance No 
Risk Management Yes 
Sarbanes-Oxley Compliance No 
Surveys & Feedback Yes 
Version Control Yes 
Workflow / Process Automation Yes 

Document Control

Archiving & Retention Yes 
Automated Routing Yes 
Change Management Yes 
Compliance Management Yes 
Electronic Signature Yes 
Escalation Management Yes 
Periodic Review Yes 
Version Control Yes 

Document Management

Access Controls Yes 
Archiving & Retention Yes 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture Yes 
Document Conversion Yes 
Document Delivery Yes 
Document Indexing Yes 
Document Retention Yes 
Electronic Signature Yes 
Email Management No 
File Recovery Yes 
File Type Conversion Yes 
Forms Management Yes 
Full Text Search No 
Offline Access Yes 
Optical Character Recognition No 
Print Management Yes 
Version Control Yes 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Risk Management

Alerts/Notifications Yes 
Auditing Yes 
Business Process Control Yes 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard Yes 
Exceptions Management Yes 
IT Risk Management Yes 
Internal Controls Management Yes 
Legal Risk Management Yes 
Mobile Access Yes 
Operational Risk Management Yes 
Predictive Analytics Yes 
Reputation Risk Management Yes 
Response Management Yes 
Risk Assessment Yes 

SPC

Corrective Actions (CAPA) No 
Data Entry No 
Data Linking No 
Data Management No 
Excel Loader No 
Job Management No 
OPC Data Collection No 
Performance Metrics No 
Point-of-Production Analysis No 
Real Time Data Collection No 
Regulatory Compliance No 

Product Features

Quality Management

Audit Management No 
Complaint Management No 
Compliance Management No 
Corrective and Preventive Actions (CAPA) No 
Defect Tracking No 
Document Control No 
Equipment Management No 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control No 
Training Management No 

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