SIMATIC IT eBR

By embedding GAMP methodologies from the ground up, SIMATIC IT eBR software offers robust, pre-validated, Life Sciences-specific solutions to effectively translate manufacturing processes into operational excellence.

SIMATIC IT eBR is based on the proven SIMATIC IT XFP platform that has enabled multiple plants worldwide to improve visibility and efficiency in their entire facility.

SIMATIC IT eBR integrates seamlessly with SIMATIC IT complementary solutions, ERP and PLM systems.

Main Benefits

  • Achieve operational excellence with optimized, controlled and secure manufacturing processes

  • Accelerate time-to-market through electronic batch reviews and releases

  • Exceed regulatory compliance with adequate cGMP features and complete manufacturing traceability

  • Promote total quality and reduce cost by eliminating errors, reducing scrap and avoiding process delays


SIMATIC IT eBR Design (MBR)

SIMATIC IT eBR Design provides an advanced workflow tool that helps optimize processes across multiple facilities. The design module enables users to design electronic templates or Master Batch Records and graphically model, maintain and optimize processes, without any IT skills required. SIMATIC IT eBR Design enables point & click modeling, reusable process objects and offers standardized work instructions.

The ISA88-compliant process hierarchy simplifies and accelerates process modeling, updates and validation. With the version control feature, it is easy to forecast the impact of process changes, thus greatly optimizing process maintenance and creation. A testing environment allows for process simulation before production.

SIMATIC IT eBR Execution

SIMATIC IT eBR Execution automates and streamlines the manufacturing processes while ensuring full compliance with FDA regulations.

Manufacturing instructions and tasks are automatically displayed to the right user through an easy-to-use and intuitive interface.

The SIMATIC IT eBR Execution module simplifies data collection, performing automatic controls and minimizing errors while the electronic batch record is being completed.

The process execution is efficient and totally secure. Process data are gathered in a central repository, where they are available for reporting and analysis. This provides extended visibility and enables continuous process improvement.

Seamlessly integrated with third party systems, SIMATIC IT eBR Execution provides full paperless manufacturing solutions.

SIMATIC IT eBR Review

SIMATIC IT eBR Review automates and streamlines the manufacturing processes while ensuring full compliance with FDA regulations.

Through configurable signature paths, SIMATIC IT eBR Review ensures and records compliant review by qualified personnel. Real-time visibility of batch review tasks allows the signatories to organize and manage their tasks with greater efficiency. They can instantly view exceptions and associated solutions, simplifying the validation process.