SIMATIC IT XFP 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 XFP 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 XFP

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

The key functionality for Life Science manufacturing is Electronic Batch Records (EBR), and XFP 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. XFP's EBR 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

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 XFP 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 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 has executed XFP 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 XFP 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 XFP experience to make your MES/EBR implementation a success.

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