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Digitalise GMP Production.
Without the Complexity.
A cGMP-ready MES for pharmaceutical,
biotech, cell& gene therapy, and
medical device manufacturers.
Digitise batch execution and support
compliance with FDA 21 CFR Part 11 and
EU Annex 11 without the complexity of a
traditional MES rollout.
BatchLine replaces paper-heavy processes with a modern, affordable MES built for regulated operations — so you scale digital quality without the complexity.
What does a Pharma MES do?
BatchLine MES creates a digital bridge between your ERP and shop floor
operations, connecting production workflows with your QMS, LIMS, equipment,
and other systems.
Your teams gain one real-time view of batch execution, review, exceptions, and
progress from material dispensing to final release.
Compliance built into every record
Electronic signatures, audit trails,
access controls, and complete documentation support FDA 21 CFR Part 11, EU Annex 11, and cGMP
requirements.
Quality at every step
Guided workflows help operators follow the laid-out process, required verification checks, and completeness checks before they move to the next stage.
“Right First Time” manufacturing
Enforce approved SOPs through controlled workflows, automate data capture and integrity checks, and enable Review by Exception to reduce review time and accelerate batch release.
Visibility & traceability across production
Track EBR execution from raw materials to finished products.
Real-time dashboards show exactly which step each batch is at in the production process.
Customer Success
See how manufacturers move from paper records to faster, fully digital GxP operations.
Start Small.
Scale with Confidence.
For pharmaceutical, biotech, medical device, cell and gene therapy, regulated cannabis, and nicotine manufacturers.
Start with 1–10 users.
Add more as production grows
Need tasks completed in sequence or
at the same time?
Configure workflows so teams can work step by step or in parallel.
Need 2 or more reviewers?
Configure multi-step reviews that match your process.
Found a mistake after approval?
Reopen, correct, and re-submit with full traceability.
Need a final sign-off?
Apply a final electronic signature after all section reviews are complete.
Want to know who changed what?
Complete audit trails show who, what, and when.
Manufacturing medical devices?
Configure BatchLine to manage Device History Records (DHRs), not just generic batch records.
Which deployment fits your team?
SaaS or private cloud (single-tenant). We’ll help you choose.
See BatchLine in action
Request a personalized BatchLine demo.
Common questions, clear answers.
For small and mid-sized pharmaceutical manufacturers, the best Manufacturing Execution System (MES) is typically a cloud-native, modular solution rather than traditional, monolithic software.
Smaller operations need systems that are affordable, easy to validate, and quick to deploy without requiring a large, dedicated IT team.
BatchLine is one option designed specifically for growing life sciences manufacturers, offering a scalable MES and EBR platform that can expand as production needs evolve.
A pharma MES should support FDA 21 CFR Part 11 and EU Annex 11 requirements through features such as electronic signatures, secure audit trails, access controls, and data integrity safeguards.
BatchLine is designed for regulated life sciences manufacturing and provides these essential capabilities to help manufacturers build and maintain compliant, validated processes.
Modern pharmaceutical MES platforms connect shop floor operations withcore business, quality, and laboratory systems to reduce data silos.Integration capabilities across ERP, QMS, LIMS, and equipment depend onthe required scope and existing system architecture.
BatchLine (Best for Small and Mid-Sized Manufacturers): BatchLine offers aflexible, scalable MES and EBR platform that can integrate with existingenterprise systems and shop floor equipment based on eachmanufacturer’s requirements.
Choose SaaS if: You have a small IT team and want faster deployment with vendor-managed infrastructure and updates.
Choose private cloud if: You need a dedicated environment and more control over integrations and validation schedules.
Choose on-premises if: Strict security policies, limited connectivity, or infrastructure requirements prevent cloud deployment.
BatchLine supports SaaS and single-tenant private cloud deployment for small and mid-sized life sciences manufacturers.
BatchLine, Apprentice.io, and Körber PAS-X Neo are designed for faster implementation and validation through cloud-based architecture, configurable workflows, and validation support.
While traditional enterprise MES projects can take 12–24 months, timelines vary by scope and system complexity. For example, BatchLine has been implemented and fully validated in as little as 4.5 months.
BatchLine provides supplier qualification documentation, including the qualification plan, risk assessment, factory acceptance testing (FAT) , requirements traceability matrix (RTM), qualification report, and controlled release documentation.
We can also support your customer-side CSV activities, including process and data integrity risk assessment, risk-based user acceptance testing (UAT) planning and execution, recipe verification, validation documentation, and operational SOPs. The scope can be tailored to your quality system and intended use.
