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BatchLine MES

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Here you’ll find clear, straightforward answers to the most common questions about BatchLine MES—how it works, how it integrates with your systems, and how it helps simplify your daily operations.

Terminology and Glossary Explanation

Explanation of the terminology and Acronyms used and how they relate to BatchLine. Which in the EBR / MES area is often confusing, as different companies use different names for the same thing.

Acronym / Abbreviation Name Details
EBR
Electronic Batch Record
An electronic record of the batch execution. This is often a subset of MES.
MES
Manufacturing Execution System
Refers to an overarching system to manage manufacturing data, master data, and operations. There is no formal definition of MES, and it can cover Order management, Recipes, MBRs, EBR, Warehouse, Inventory, Material management, Logbooks, and more.
MBR
Master Batch Record
The primary document in the pharmaceutical, medical device, and Cell and gene therapy production industry that compiles complete formulations, ingredients, manufacturing procedures, quality controls, and instructions—used as a master template before initiating production for each batch.

General System Functionality

Yes, customers can revise specific sections of the EBR. However, when creating a new
revision, it is treated as a single document. This means any changes need to be made to
the complete Master Batch Record (MBR), followed by a review, approval, and activation
before it can be used.

To create a production batch record, you first need to build a Master Batch Record
(MBR) Specification, which includes the entire process flow and serves as the master
specification. The MBR acts as the blueprint, and the Batch Production Record (BPR)
documents the execution of that blueprint for each batch. Both BMR and BPR can be
created independently or integrated into a single flow, depending on user preferences
and operational needs.

The system allows users to design MBRs for both commercial and non-commercial batches. Users can leverage the filtering function within the system to easily separate and manage commercial EBR from pilot or trial EBR. This classification ensures that each type of batch is handled according to its specific requirements and intended use.

The system can be configured to ensure steps are completed sequentially or in parallel,
with necessary reviews and verifications. This setup is defined during the MBR
specification design workshop.

Integration Capabilities

BatchLine Lite MES can seamlessly integrate with Laboratory Information Management
Systems (LIMS) and Enterprise Resource Planning (ERP) systems via REST API
connectors. This integration enables fluid data exchange and streamlines operations.


Typical Use Cases:

  • LIMS Integration: Automatically transfer laboratory results and quality control
    data into the batch recording system, ensuring production only uses tested and
    approved materials.
  • ERP Integration: Sync production order schedules and material consumption
    data between ERP and MES.
    These integrations enhance operational efficiency, reduce manual data entry, and
    improve accuracy by maintaining a single source of truth across systems.
The system can be integrated with weighing scales for reading the weighing data. To
integrate, the scale should connect with our Gateway to communicate. BatchLine uses
the MQTT protocol, so a Gateway is needed. The scale also needs to have interfacing
capability.

Yes, BatchLine can integrate with barcode scanners, enhancing the efficiency and
accuracy of data entry.

Instruments used for tests such as leak test, hardness, friability, and moisture content can be integrated into the EBR by automatically receiving data from cloud-based sources. If the data is not available on the cloud, it can be entered manually. Results recorded in the EBR undergo a review and approval process by designated personnel to ensure accuracy and compliance.

Operation and Continuity

Exceptions in the manufacturing process are managed by Batchline, which tracks
production-related exceptions requiring review and approval by a supervisor and QA.
Any deviations resulting from these exceptions should be addressed through
the customer’s QMS.

In the event of a power failure, the last submitted data is securely saved in the system, ensuring no data is lost or corrupted. If there is a connectivity issue, production can continue using a PDF specification for manual entry. Once the connection is restored, the completed PDF can be uploaded to the EBR system to ensure all records are properly integrated and attached.

Support

Support requests are managed through the JIRA ticketing system, which is available to customers at any time. Customers can submit issues, requests, or inquiries directly through the portal for tracking and resolution.

Each support case is evaluated based on its impact (extent of effect on operations) and urgency (how quickly resolution is needed). This determines the case priority level (e.g., high, medium, low or no priority).

The Service Level Agreement (SLA) is defined in the support contract and specifies the target response and resolution times according to the assigned priority level.

For example:

  • High: Immediate acknowledgment and priority resolution
  • Medium: Response within agreed timeframe and expedited handling
  • Low/ No priority: Handled within standard business response times

Support is available according to the service coverage defined in the contract.

(e.g. during business hours or up to 24/7)

All updates, status changes, and communication are maintained within the JIRA system, allowing customers to track progress and communicate with the support team in real time.

Support typically includes:

  • System incidents or malfunctions
  • Technical troubleshooting
  • User access or configuration issues
  • Guidance on system usage or functionality

Enhancement or change requests may be handled separately as part of change management or project scope discussions.

To ensure faster resolution, please include:

  • Clear description of the issue
  • Steps to reproduce (if applicable)
  • Screenshots or error messages
  • System or environment details
  • Contact person for follow-up

Implementation

The expected timeline for the EBR scope with ERP integration is approximately 4-6
months, depending on the readiness of interfaces from the customer’s side. We can
conduct an onsite assessment to understand the machine’s current capabilities and
determine which machines will be connected as part of the project scope. This
assessment can typically be completed within one day’s visit.

We provide comprehensive training for key users, including operators, supervisors, QA
for batch execution, review, approval, and archiving, MBR builders, and administrators.
These training sessions are usually completed within 3-5 days.

Upgrades

On average, we release upgrades twice a year. Users with their own virtual
private cloud (VPC) environment have more flexibility about when upgrades are
deployed. We encourage upgrading to the latest version for better performance and
enhanced functionality.

Ready to get started?

Discuss your business requirements with one of our consultants and arrange a demo.

Contact us