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What is MyCellHub?

Optimize the various processes related to batch records, sanitation, environmental monitoring, and inventory management. Leverage software designed specifically for Good Manufacturing Practice (GMP) to improve the production of advanced therapies. This solution acts as a cohesive platform to align your team towards achieving manufacturing excellence on the first attempt. Remove the disarray caused by fragmented documentation by employing a singular software system that streamlines data gathering, review, approval workflows, detailed reporting, and valuable analytics. Ensure your staff follows the appropriate protocols in a timely manner with interactive work instructions that guide them through every stage. Rest assured that this software adheres to 21 CFR part 11 and EU Vol 4 annex 11 regulations. Ease the process of information recording with features such as barcode scanning, embedded data integrity safeguards, and automated calculations. The system also possesses features for detecting out-of-spec conditions and ensuring comprehensive review and approval processes. Keep track of your samples during the testing phases seamlessly, while efficiently arranging sample plans and automating trend analysis. Furthermore, oversee tasks related to maintaining cleanroom protocols and track various production stages to guarantee optimal outcomes. This holistic strategy not only boosts operational efficiency but also cultivates a culture of responsibility and accuracy within the manufacturing environment, ultimately leading to better product quality and compliance.

What is Dot Compliance QMS?

Dot Compliance has introduced the first ready-to-use Quality Management Solution integrated with the Salesforce.com platform. This innovative solution encompasses a comprehensive array of pre-configured eQMS and compliance processes, allowing clients to implement it swiftly and affordably. Included in the Dot Compliance offerings are complete project validation services alongside product validation packages. Their solution stands out as the most economical option for quality and compliance management in the industry, empowering users to deploy adaptable and scalable solutions without delay. Key quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, and Supplier Quality can be automated effortlessly. Furthermore, the solution is designed to be fully configurable and supports seamless integration, which makes it easy for customers to tailor the system to meet their unique specifications. By prioritizing user needs, Dot Compliance ensures a smooth transition and effective management of quality across various operations.

Media

Media

Integrations Supported

Salesforce

Integrations Supported

Salesforce

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

$10,000 / Annually
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

MyCellHub

Date Founded

2019

Company Location

Belgium

Company Website

www.mycellhub.com

Company Facts

Organization Name

QMS for Life Sciences

Date Founded

2007

Company Location

United States

Company Website

www.dotcompliance.com

Categories and Features

Manufacturing Execution

Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability

Categories and 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
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management

Complaint Management

Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey Management

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

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
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

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

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

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