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Up-to-date plans. Error-free execution. Anywhere approvals.

Bio-manufacturing execution system for GMP

Batch records, cleaning, environmental monitoring & inventory management

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See how it works

Manufacturing Excellence

Optimize advanced therapy production with software designed for GMP. It’s one more way to align your workforce for ‘right first time manufacturing’.

Built for

GMP facility services

Cell and gene therapies

CDMOs

Connect your departments

Get rid of fragmented paperwork with one software that everyone can use for data collection, review & approval workflows, reporting and analytics.

Illustration of departments in life science manufacturing connected by MyCellHub

Illustration of a person filling up a test tube while getting instructions from a tablet

Reduce risk

Ensure your team follows the correct steps in due time and enable ‘right-first-time' manufacturing with interactive work instructions.

GMP compliance by design

21 CFR part 11 and EU Vol 4 annex 11 compliant for your peace of mind.

A diagram showing the connection between a laptop and tablet

Accurate data entry and fast approvals

Make logging information intuitive with bar code scanning, built-in data integrity checks and automated calculations. Highlighting out of specs and review by approval comes built-in.

Discover modules

Electronic batch records

Track any production process

Cleanroom cleaning

Manage tasks to keep cleanrooms clean

Environmental monitoring

Organize sample plans and automate trending

Sample tracking

Know where your samples are in the testing process

Cleanroom testing

Know where your samples are in the testing process

Extensions to our platform

Inventory management

Track stock levels and expiration dates

Training management

Keep track of your workforce’s L&D

Equipment management

Know when to maintain your devices

Device integration

Connect hardware and software

From:

1. Complex manual operations
Time-consuming and error-prone manual efforts for masterplan preparation and scheduling, data entry, and audit preparation.
2. Inefficient paperwork management
‍Multiple hours a week spent per schedule on paperwork logistics including printing, pickups, and deliveries.
3. Complex manual operations
Manual work to remain compliant was time-consuming and tedious.

To:

1. Simplified task management
Significant time saved and fewer errors with MyCellHub's automated system from masterplan prep to task allocation and logging to reporting.
2. Efficient digitalized documentation
Elimination of physical paperwork, streamlining the logistics and management processes.
3. Seamless compliance
Smooth GMP compliance with automated documentation and improved traceability.

Start at your own pace.

Digitalizing your facility is no small feat.
We’re here to help, every step of the way.

Vanessa Morini from cleanroom cleaning company TRU

"Since we started collaborating with MyCellHub the data is digital and accessible from anywhere, sign-off is easy, saving even more time and making it easier to detect mistakes."

Vanessa Morini, CEO TRU