Paperless manufacturing, the key to operational efficiency
“If it’s not written down, then it didn’t happen!”. Strict regulation, known as Good Manufacturing Practices (GMP), requires biotech and pharmaceutical production process 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.
Digitalising GMP workflows are the key to scale 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.
Advantages of Electronic Batch Records over paper-based workflows
- "Right-First-Time" manufacturing with interactive work instructions
- 75% time savings with automated reporting, online review and release mechanisms
- Real-time synchronisation of equipment status and raw material inventory
- Increase data integrity with built-in calculation, barcode scanning and resource status checks
- Facilitate 21 CFR part 11 and EU Vol 4 annex 11 compliance
Interactive work instructions
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 digitalises any workflow in manufacturing, material reception, quality control, or maintenance.
Get up and running quickly by starting from our library of standard unit operation. Make use of MyCellHub’s smart workflow parameterisation to anticipate variations in processes executions.
Real-time data recording
Get reminded when and how to collect process data during the execution of a workflow. Built-in data integrity checks and warnings actively prevent operators from making mistakes. As data is synced in real-time, instant verifications of expiry dates and updates of inventory levels streamline data flows within your whole facility.
Regulatory compliance
Improved data quality and data integrity facilitate regulatory compliance. MyCellHub is designed for use in GMP environments and therefore actively supports the user with 21 CFR part 11 and EU vol. 4 Annex 11 compliance.
Remote review and approval
Remotely monitor the progress of each workflow in real-time. Operators, production mangers or QA can review, provide comments and approve the execution of a workflow.
Data integration
Get rid of data silo’s and have all data you need to efficiently manage your operations at the tip of your fingers. Contact us to discuss integrations with your LIMS, ERP or manufacturing devices.
What's next?
Schedule a demo with one of our experts to learn how MyCellHub can help digitalise your GMP workflows.
Or learn more about the key requirements for an efficient Electronic Batch Record on our blog.