SIMATIC IT ebr 6.1SP1

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1 SIMATIC IT ebr 6.1SP1 Release of SIMATIC IT ebr 6.1 SP1 (December 2016) SIMATIC IT ebr 6.1 SP1 is the latest software update of the Siemens MES solution for electronic batch recording in life sciences manufacturing, new version of the successful and proven SIMATIC IT ebr / XFP platform that has been installed in over 130 production environments around the world. Principal new features in version 6.1 SP1 include some enhancements of the Master Batch Record module to include the management of the Bill of Materials, additional information in the Project Startup package, and a list of new functionalities embedded in the native integration with Siemens PCS7 Batch. This new service pack also brings the standard support of Windows 10 for Client workstations. Product announcement - Siemens AG All rights reserved.

2 Product announcement SIMATIC IT ebr 2 Target Customers The target customers for SIMATIC IT ebr are manufacturers in regulated industries that are looking to use a Manufacturing Execution System to secure and standardize their entire manufacturing operations and move towards paperless manufacturing. Typically, target customers will come from the pharmaceutical and biotechnology industries, but also Fine Chemical manufacturers and Cosmetics industry. Product Features As a complete electronic batch record system, SIMATIC IT ebr provides advanced features to design, streamline and manage operation processes. The efficiency of all resources is maximized: user guidance, equipment allocation, operating procedures. Every operation within production execution, whether human or PLC controlled, is controlled and tracked. The system permits the review of the product batch record by exception, providing faster and more efficient release products. Powered by an advanced workflow engine, SIMATIC IT ebr can be used to direct manufacturing, while also recording and centralizing all the information required for the review of the completed batch record, therefore enabling release by exception. Management of Master Batch Records facilitates the Key process parameters. SIMATIC IT ebr includes: Out of the box configurable modules for Weighing & Dispensing, Compounding, Equipment Management, Formula Management and Material Flow Management integrated with a flexible process management modules featuring Work Flow and Work Instruction management for Master Batch Record and Electronic Batch Record application System integration capabilities for connecting both enterprise system (ERP, APS, WHM, LIMS ), automation system (SCADA, DCS) and devices such as scales, label printer or barcode reader SIMATIC IT ebr is compliant with pharmaceutical regulation and is delivered with: o o Guidelines for compliance with standards such as 21CFR part 11, GHS and GAMP Templates of protocols for Installation Qualification(IQ) and Operational Qualification(OQ) covering all SIMATIC IT ebr modules Siemens MES Portfolio synergies SIMATIC IT ebr is part of a larger portfolio for regulated industries: Natively integrated with SIMATIC PCS7 Batch via SIMATIC IT Batch Integration Layer (BIL) Connected with the Siemens manufacturing bus: SIMATIC IT Unified Architecture Foundation Integration with Siemens Advance Planning and Scheduling (Preactor), Siemens Laboratory Information Management Systems (Unilab), Siemens weighing modules (Siwarex)

3 Product announcement SIMATIC IT ebr 3 Siemens life sciences solution The Siemens solution for life sciences offers a native integration between the Siemens MES and DCS using SIMATIC IT ebr and SIMATIC PCS7 Batch. This allows an interaction between the different systems at the time of design, execution and review. Electronic Batch Record Design Within SIMATIC IT ebr, an easy-to-use design tool allows users to design processes and implement master batch records (MBR) without the need for IT skills. Recipe information is available in the MES design tool and MES workflow steps can be integrated by simple selection from the list of released master recipes. The combination of reusable building blocks, easy text editing and out-of-the-box functions permits standardization, a reduced development effort and a faster release of the master record. Electronic Batch Record Execution During production, every operation and resource is controlled, tracked, and traced. All the systems coordinate real-time control at every level, synchronizing operations and sharing parameter values. Process rules and sequences are enforced through the workflow engines. The system can integrate with information from other systems such as the enterprise resource planning (ERP) system, lab systems (LIMS) and pull them together to guide manual operations and to track and to trace materials and resources. Electronic Batch Record Review SIMATIC IT ebr automates and streamlines the manufacturing processes while ensuring full compliance with FDA regulations. Through configurable signature paths, SIMATIC IT ebr 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

4 Product announcement SIMATIC IT ebr 4 Customer Benefits SIMATIC IT ebr enables life science manufacturers to achieve operational excellence, accelerate time to market, reduce the cost of compliance and improve quality and productivity. Paperless process Reduce paper use until the system can handle all processes electronically Reduction of development effort and risk Integrate MES and DCS in order to simplify the architecture, to reduce configuration effort (especially with regards to the interfaces) and to lower the total cost of ownership Standardized libraries of process operations Reuse functional blocks and parametric MBRs, to enable harmonization their processes and facilitate global implementation across sites Single point of review of batch-relevant information Reviews are faster and safer and enable release by exception New Features Version 6.1 SP1 of SIMATIC IT ebr is a functional enhancement of the previous SI- MATIC IT ebr version 6.0 (based on former XFP Solution) and provides the following new features: New features of SIMATIC IT ebr 6.1 SP1 Improvements on MBR module to include management of a Bill of Material (formula) and to present iterative parameter set in better way The possibility to call the Batch Element in an Event PI: Possibility to recursively call a Batch in SIMATIC PCS7 from the MES workflow triggered from another Batch in SIMATIC PCS7 Enhancements on the disconnection on Task list control designed to be integrated in HMI system (WinCC) Additional query on Startup Package to create reports or KPI on standard data Support of Windows 10 for client workstations Features of SIMATIC IT ebr 6.1 MBR module to simplify critical parameters management providing synthetic ebr report comparing execution and master data Native integration to SIMATIC PCS7 (Ability to call PCS7 Batch control recipe from ebr workflow, Call of ebr workflow from PCS7 Batch phase, Dynamic call of operating text from batch, without event workflow, to improve rendering of batch phases in ebr and simplify configuration of product specific processes) Task list ActiveX control designed to be integrated in HMI system (WinCC)

5 Product announcement SIMATIC IT ebr 5 Project Startup package including label template, scripts and SQL queries to create reports or KPI on standard data Support of Latin or UTF8 (Unicode) character encoding Generation and attachment of document to an electronic batch record New weighing mode to perform weighing with a graduated cylinder as a virtual scale Improved configuration of electronic signatures to facilitate the management of a single check, a double check or a conditional check, after a manufacturing operation such as a weighing New management of expiry dates: o Based on opening time (shelf life) o Accuracy level improved to nearest minute High availability for shop floor connections Windows CE based Unicode client for radio frequency (not only Teklogix) Support of o Windows server 2008 R2 and 2012 o Windows workstation 7 and 8.1 o Internet explorer 11 o Oracle 11g R2 and 12c