The Efficient EBR System For ATMPs

Advanced Therapy Medicinal Products (ATMPs) offer great new opportunities for the treatment of patients and their diseases or injuries. In ATMP laboratories and cleanrooms all over the world, experts work on the manufacturing and quality control of these medicines, based on genes, tissues or cells. 

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Features

Especially designed for ATMPs

Efficient management of workflows plays a crucial role in laboratories and cleanrooms.  

 

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Design Your Master Batch Record Workflow

Point&Click interface to easily create all steps in your EBR workflow

ATMPKick allows you to create a step-by-step workflow in which you can define different types of steps which must be executed in consecutive order.

In each step you can define different fields which will be used to receive input during step execution. Besides the usual field types (numeric, text, etc.) you can also define a formula which automatically performs calculations using values from other fields.

Additionally you can define Out Of Spec (OOS) values for the different form fields which will be automatically checked and raised during batch execution.

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Execute Batch Runs Easily

User-friendly interface for step-wise batch execution

Once you validate the previously designed Master Batch Record, you can assign it to a patient and start a batch run. The user-friendly point&click interface guides the operator through all the necessary steps and allows to record the relevant data.

Calculations are performed automatically and Out Of Spec (OOS) events can be reviewed, after which a batch can be released remotely by the Qualified Person (QP).

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Manage Patients, Cleanrooms, Facilities, and more...

You can manage these aspects within the system or easily integrate with other systems to obtain data

Within ATMPKick you can  already manage aspects like patients, cleanrooms, facilities and locations, to enable you to have all the data you need. Other data management requirements or integrations with external systems and instruments can easily be developed on top of it.

ATMPKick Whitepaper

Please, fill in the form to download the ATMPKick whitepaper.

ATMPKick™ Advantages

Digitalize and automate ATMP workflows and work remotely with multiple cleanrooms, hospitals and operators. 

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An easily accessible web-based solution

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Specifically designed for ATMPs, allowing centralized follow-up and release of multiple, decentralised production sites

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Customizable for different types of manufacturing sites

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Suitable for decentralised and personalised manufacturing

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Possibility for dynamic checklist creation and batch runs

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Developed according to FDA 21 CFR part 11 compliance guidelines

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Cloud-based set-up with backup and disaster recovery out-of-the-box

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Assignment of different roles and tasks to different people

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Very easy to validate, as validation was a key focus during development

What people are saying

"ATMPKick was the ideal solution for us to efficiently manage our production workflows and quality control. Together with QbD Software we developed a customised version, tailored to our specific working methods and needs."

— Hans de Munter, CEO at Neuroplast

"ATMPKick was the ideal solution for us to efficiently manage our production workflows and quality control. Together with QbD Software we developed a customised version, tailored to our specific working methods and needs."

— Hans de Munter, CEO at Neuroplast

Contact Us

If you would like to receive a demo, pricing or more information, please fill in the form below.