Siemens SIMATIC IT Electronic Batch Records (EBR)


SIMATIC IT EBR is an Electronic Batch Records (EBR) and Manufacturing Execution System (MES) platform from Siemens, focused specifically on Life Science manufacturing.

More than 120 plants worldwide have utilized SIMATIC IT EBR to improve efficiency, quality and visibility in Life Science production processes including Bio-technologies, Blood Fractionation, Chemical API, Drug Manufacturing, Vaccine Manufacturing, Cosmetics and Neutraceuticals.


Source: Siemens SIMATIC IT EBR

Functionalities of SIMATIC IT EBR

As a fully functional MES platform, SIMATIC IT EBR provides many of the functions you would expect from a traditional MES including:

  • Material genealogy
  • Tracking and tracing
  • Lot/container-level inventory management
  • Work order management
  • Equipment status and lifecycle management
  • Manufacturing business intelligence and reporting
  • Plant floor data collection

Additionally, since SIMATIC IT EBR is specifically optimized for Life Science manufacturing, it goes a step further by providing a host of features geared towards this challenging industry. SIMATIC IT EBR is fully compliant with ISA-95 regulations and the core software comes pre-validated to GAMP 5 standards.

Features of SIMATIC IT EBR

The key functionality for Life Science manufacturing is Electronic Batch Records (EBR), and SIMATIC IT EBR delivers a powerful and intuitive EBR engine that enables a more streamlined, paperless and automated process while ensuring full compliance with FDA and international regulations. SIMATIC IT EBR's engine enables exciting features, including:

  • Paperless shop floor with Electronic Batch Records (EBR)
  • Built-in standard weighing and dispensing management
  • Electronic record and electronic signature storage compliant with 21CFR11
  • Automated enforcement of cGMP procedures
  • Built-in data validation and alert tracking enabling batch review and release by exception
  • Increased process visibility with built-in GxP reporting capabilities

Benefits of SIMATIC IT EBR

This fusion of out-of-the-box MES and EBR functionalities creates an impressive array of benefits that should appeal to any Life Science manufacturer. By utilizing the key features of SIMATIC IT EBR to help drive your manufacturing process while tracking and collecting critical process data in real-time, you can increase quality and productivity while simultaneously reducing cycle times and increasing process visibility. Benefits of a MES/EBR system include:

  • Decreased cycle times and accelerated time-to-market via electronic batch review and release
  • Reduced costs (reduction in rework, deviations and research time) through automated error checking and process controls
  • Improved regulatory compliance driven by built-in cGMP features and complete manufacturing traceability
  • Greater process visibility due to built-in GxP reporting and genealogy features
  • Improved quality as SIMATIC IT EBR allows you to build institutional knowledge and best practices into your process while delivering instructions for them in a clear and consistent format

Hyla Soft's Expertise 

Hyla Soft has executed SIMATIC IT EBR projects of all sizes, from a pre-weighing system for an over-the-counter pharmaceutical manufacturer to the development and qualification of a full Electronic Batch Record, Equipment Management and Stock Management system for one of the largest vaccine producers in North America.

As Siemens’ preferred integration partner, Hyla Soft consultants are the leading functional experts on SIMATIC IT EBR in North America and have participated in and led implementations all over the world. Our deep product knowledge combined with our Life Science sector experience gives us insight into the specific needs and requirements of companies in this challenging industry. From solution design and quality planning, to project management and execution, to system integration and validation, Hyla Soft has the SIMATIC IT EBR experience to make your MES/EBR implementation a success.

Interested in speaking to one of our experts? Contact us at

Xfp 2
Article Template Based Manufacturing Feature Image 72

Apr 29, 2016

Video Machine Shop Job Management Feature Image 721X42

Feb 15, 2016


Contact Us