GMP Facility Services

The easiest implementation of GMP processes and quality control.

Without paperwork. Without complicated tools.
With peace of mind.

Improve your operational efficiency

Going digital with MyCellHub means that you can easily see what needs to be done at each facility and where your team is in the process.

Easily track the ins-and-outs of each facility

Every customer you work with is totally unique. MyCellHub’s platform is easy to adapt to every workflow so you’ll never overlook an important step.
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Flexible solutions to meet your needs
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Flexible solutions to meet your needs
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Flexible solutions to meet your needs
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Flexible solutions to meet your needs
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Flexible solutions to meet your needs
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Flexible solutions to meet your needs
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Flexible solutions to meet your needs
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Flexible solutions to meet your needs
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Flexible solutions to meet your needs
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Flexible solutions to meet your needs
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Flexible solutions to meet your needs
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Our intelligent workflows bring efficiency across life science teams

Reduce risk by preventing errors

Get granular control of productions & prevent errors to reduce risk.

Optimize your workflows based on analytics

Bring data together automatically to create accurate batch records and gain insights across processes to optimize your workflows based on analytics.

Ensure accuracy and standardization in your workflow

Define step-by-step processes with user consent to proceed to ensure workflows are executed correctly

Gain more control and get notifications to know when you're needed

Release batches confidently with near-real-time document compliancy to gain more control.

Get what you need at your fingertips instead of compiling lenghty reports

Compiling reports has never been easier. All data is already entered into the software so all you need to do is hit export and your report is complete.

Ensure accurate data input

Enforce data integrity throughout the entire manufacturing process to ensure accurate data input.

Works with your current systems

Our platform easily integrates into your existing software with APIs.

Compliant out of the box

Move towards a paperless operation leveraging EU Annex 11 and CFR part 11 compliance.
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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How it works
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MyCellHub’s Electronic Batch Recording app provides interactive step-by-step work instructions and enables the user to collect process data in real-time.

The workflows are extremely versatile. Additionally, since the app is compatible with both tablets and computers, MyCellHub digitizes any workflow in manufacturing, material reception, quality control, or maintenance.

Get up and running quickly by starting from our library of standard unit operations. Make use of MyCellHub’s smart workflow configuration to anticipate variations in process executions.

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What our users have to say

With electronic batch records, our processes are effortlessly standardized and errors dramatically reduced.

Future you with MyCellHub
SVP Quality

I can now generate environmental-monitoring trending analysis and reports in a simple click. What a game-changer!

Future you with MyCellHub
Head of QC

All of our cleanroom-cleaning data is now on one single platform and we can work faster.

Future you with MyCellHub
Facility Manager
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Frequently asked
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Frequently asked
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Frequently asked
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Frequently asked
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Frequently asked
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Frequently asked
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What is the pricing model?

MyCellHub is a Software as a Service (SaaS) platform, you only pay for what you use!

We allow you to focus on what matters most to you while we take care of all the technical things like server configurations, cloud deployment, hosting, validation and daily data back-ups.

If needed, MyCellHub offers Professional Services on a project basis, delivered by our Customer Success team.

Contact us at info@mycellhub.com for a tailored quotation.

Can I integrate MyCellHub with other systems?

Yes! MyCellHub is designed to communicate with external systems.

For software this is done via an API integration. For hardware we set up OPC communication.

MyCellHub works with specialized partners to make custom integrations.

What is included in the user license?

Peace of mind!

The license fee includes cloud hosting, built-in back-up services, user manual, training material, and all future updates of the current software modules with a change control mechanism that allows the user to remain in a validated state continuously.

Additionally, MyCellHub provides customer support and validation documentation for Installation Qualification and Operational Qualification.

I want to use the software in a GMP environment. What about validation?

MyCellHub comes validated out of the box!

As part of the user license, MyCellHub provides customer support and validation documentation for Installation Qualification and Operational Qualification. 21-CFR-part-11 and EU GMP-annex-11 documentation is available as well. We can also assist you with the generation of Performance Qualification templates.

Can I implement this on my own servers or is it only cloud?
The software is designed to be hosted in the cloud.

But
it is entirely possible to deploy it on a local server as well if cloud is not an option. We don’t recommend on-premise installation for companies without an internal IT-team.
How long does it take to implement your platform?
It depends. Technically speaking, the deployment of the software in cloud servers takes 20 minutes. Building and preparing validation of simple workflows takes a couple of days.

But for most installations that are handling a dozen GMP processes, the deployment (configuration of customer-specific workflows + installation + validation + training) could take up to 6 months. If a lot of tailor-made integrations are needed, or if there are hundreds of processes to digitalise and validate, it could take even longer. In summary, it depends on your User Requirements.
What are the different service levels?
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Do you have any case studies in the field of ATMPs?
We realised a business case based on data gathered with a large biopharmaceuticals company. This report is available on request.
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Ready to see
MyCellHub in action?

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Or contact us directly:

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Kempische Steenweg 303/200
3500 Hasselt, Belgium
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demo@mycellhub.com