Electronic Batch Records

“If it’s not written down, then it didn’t happen!”. Strict regulation, known as Good Manufacturing Practices (GMP), requires biotech and pharmaceutical production processes to be thoroughly documented. Ultimately, this process information ends up in a batch manufacturing record. Check out our blog to learn what information is included in a batch record.

‍Collecting and managing all this data on paper is a challenge. Manually filling out paperwork is prone to errors, the papers need to be handed over between multiple stakeholders, reviews and approvals tend to get delayed and in the end, all the data ends up locked up in a paper data silo.

‍Digitalizing GMP workflows are the key to scaling your operations without compromising quality.
MyCellHub’s Electronic Batch Record application provides interactive work instructions and automated data collection tools, These tools actively support operators and manufacturers to guarantee product quality in the lab and in the cleanroom.

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 digitalizes 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 parameterization to anticipate variations in process executions.