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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 BatchLine?

Tailored for pharmaceutical and other organizations adhering to GxP standards, this innovative solution optimizes the digitization of manufacturing workflows, quality assurance, and compliance with regulatory frameworks. By leveraging data-driven decision-making, teams are equipped to swiftly react to real-time developments, thereby improving overall performance and effectively addressing quality issues as they emerge. Provide operators with a user-friendly tool designed to ensure they can achieve precision on their initial attempts. The complexities of manufacturing increase significantly when considering GMP regulations; however, by arming your teams with the right resources, you can confront substantial challenges and realize noteworthy advancements. This strategy significantly reduces the time and effort required for batch review and approval by implementing review-by-exception, which negates the necessity of scrutinizing complete batch records. Additionally, it automates cumbersome processes such as manual data entry and verification, the circulation of paper documents within the production environment, and the management of calculations and workflows, ultimately boosting operational efficiency and productivity. In this manner, organizations can cultivate a more streamlined and effective manufacturing landscape, paving the way for continuous improvement and innovation.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
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

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

BatchLine

Date Founded

2015

Company Location

Thailand

Company Website

batchline.com

Categories and Features

Manufacturing Execution

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

Categories and Features

Manufacturing Execution

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

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