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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 MasterControl?

Bringing innovative products to market in heavily regulated sectors often feels like an unending series of compromises. However, MasterControl's GxP software streamlines workflows, ensuring that you don't have to sacrifice quality for cost or innovation in the face of regulation. With a perfect blend of completeness and connectivity, combined with a focus on flexibility and speed, MasterControl Quality Excellence turns quality data and processes into a significant competitive advantage. The journey toward modernizing your manufacturing operations begins with advanced software solutions. MasterControl Manufacturing Excellence simplifies the digital transformation of manufacturing, covering everything from work orders and production records to logbooks and work instructions, making it the most straightforward approach to digitizing your manufacturing processes.

What is DELMIAworks?

To enhance the efficiency of your production floor, integrate manufacturing, MES, and supply chain software into a cohesive system. Discover how DELMIAworks, previously known as IQMS, can enhance transparency across your manufacturing processes and tackle the toughest production challenges. By minimizing downtime, you can boost manufacturing efficiency, product quality, profit margins, and overall operational excellence. Access to real-time data throughout the supply chain significantly enhances decision-making capabilities. A single system can accommodate all ERP, manufacturing, MES, and supply chain needs. Streamlining your operations through automation can drastically reduce both your investment and ongoing maintenance expenses. With our user-friendly solution, you can significantly increase your plant's output while reducing human errors and refining production planning efficiency. To further mitigate unplanned downtime and maximize throughput, it is essential to effectively manage, monitor, and track every facet of the production line. Additionally, OEE graphs and charts receive dynamic updates with real-time performance and quality metrics, ensuring you have the latest insights at your fingertips. By implementing this comprehensive approach, you can transform your manufacturing environment into one that is both agile and resilient.

Media

Media

Media

Integrations Supported

DELMIA Apriso
DELMIA Ortems
Inspired eLearning HR & Compliance
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Protected Flow Manufacturing
Res_Q
SAP Business ByDesign
Showpad Coach
Tactic
VIPRE Security Awareness
Vergo

Integrations Supported

DELMIA Apriso
DELMIA Ortems
Inspired eLearning HR & Compliance
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Protected Flow Manufacturing
Res_Q
SAP Business ByDesign
Showpad Coach
Tactic
VIPRE Security Awareness
Vergo

Integrations Supported

DELMIA Apriso
DELMIA Ortems
Inspired eLearning HR & Compliance
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Protected Flow Manufacturing
Res_Q
SAP Business ByDesign
Showpad Coach
Tactic
VIPRE Security Awareness
Vergo

API Availability

Has API

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

$25,000 / 1st year
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
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

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

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

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

MasterControl

Date Founded

1994

Company Location

United States

Company Website

www.mastercontrol.com

Company Facts

Organization Name

Dassault Systemes

Date Founded

1981

Company Location

France

Company Website

www.iqms.com

Categories and Features

Manufacturing Execution

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

Categories and Features

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

Document Version Control

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

EHS Management

Audit Management
Corrective / Preventive Actions
Environmental Management
Environmental Risk Assessment
Forms Management
Incident Management
Industrial Safety Management
Injury Reporting
Inspection Management
MSDS
OSHA Recordkeeping
Occupational Health Management
Safety Risk Assessment
Training Management
Waste Management

Manufacturing Execution

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

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

Safety Management

Audit Management
Corrective / Preventive Actions
Incident Management
Injury Reporting
Inspection Management
OSHA Recordkeeping
Safety Risk Assessment
Training Management

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

Work Instructions

Branding & Style Sheets
Content Management System
Drag and Drop
Dynamic Tags
Employee Feedback
Guide Approval Workflows
Media Editor
Multi-Brand Publishing
Rich Text Editor
SSO (SAML)
Translations
User Management
Version Control

Categories and Features

ERP

Accounting Integration
Accounting Management
CRM
Dashboard
Distribution Management
Enterprise Asset Management
Financial Management
HR Management
Inventory Management
Order Management
Project Management
Purchase Order Management
Purchasing
Reporting/Analytics
Sales Management
Supply Chain Management
Warehouse Management

Job Shop

Billing & Invoicing
Capacity Management
Job Costing
Job Tracking
Order Management
Purchasing
Quality Control
Quotes / Estimates
Scheduling
Shipping Management
Traceability
Work Order Management

Manufacturing

Accounting Integration
ERP
MES
MRP
Maintenance Management
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping Management

Manufacturing Execution

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

MRP

Bills of Material
Compliance Management
Document Management
Forecasting
Formula Management
Inventory Management
Order Management
Process Manufacturing
Product Configurator
Production Scheduling
Quality Control
Quality Management
Quote Management
Reporting/Analytics
Resource Management
Safety Management
Supplier Management
Supply Chain Management

Production Scheduling

"What If" Scenarios
Automated Scheduling
Bottleneck Optimization
Capacity Planning
Constraint Scheduling
Job Scheduling
Material Planning
Priority-Based Scheduling
Quality 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

Vendor Managed Inventory (VMI)

Audit Trail
Bin-Level Management
Compliance Management
Demand Forecasting
EDI
Lot & Shelf Life Management
Performance Metrics
Self-Service Portal
Serial Number Control / Management
Sourcing Management
Transaction History
Vendor Master Data Management

Warehouse Management

3PL Management
Barcoding / RFID
Category Customization
Channel Management
Demand Planning
Inventory Management
Location Control
Order Management
Purchasing
Quality Control
Receiving / Putaway Management
Returns Management
Shipping Management

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