What’s new in SIMATIC IT eBR version 6.1 SP3

Providing a paperless solution for the pharmaceutical market

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Benefits • Reduces paper use until all processes

can be performed electronically

• Reduces development effort and risk by integrating your MES and DCS in order to simplify the architecture, reduce configuration effort (espe-cially in regards to interfaces) and lower ownership cost

• Standardizes libraries of process oper-ations so you can re-use functional blocks and parametric MBR to enable standardization and harmonization processes and facilitate implementa-tion across sites

• Delivers single point of review for batch-relevant information, making reviews faster and safer, and enabling release by exception

SummarySIMATIC IT eBR enables life sciences industry manufacturers to achieve operational excellence, accelerate time-to-market, reduce compliance costs and improve quality and productivity.

With SIMATIC IT eBR, the efficiency of all resources, including user guidance, equipment allocation and operating procedures, is maximized. Every opera-tion in production execution, whether human or programmable logic control-ler (PLC) controlled, is managed and tracked. The system permits the review of the product batch record by excep-tion, providing faster and more efficient release products.

Powered by an advanced workflow engine and an easy-to-use electronic work instructions concept, 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, thereby enabling release by exception. Managing master batch records facili-tates the key process parameters.

Figure 1: New application services console

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What’s new in SIMATIC IT eBR version 6.1 SP3

The Siemens solution for eBR manage-ment offers native integration between the MES and the DCS layer. This expe-dites the design, execution and review steps of eBR and provides real flexibility in the MBR design.

SIMATIC IT eBR enables all regulated processes to be managed without paper-based procedures or documents. The system offers easy configuration and out-of-the-box functionality and allows users to design any process without specific information technology (IT) skills.

Fully compliant with U.S. Food and Drug Administration (FDA) and good manu-facturing practice (GMP) regulations, the system optimizes batch manufactur-ing processes and helps streamline resources, such as user guidance, equipment allocation and standard operating procedures (SOPs). It also systematically controls the correct execution of all stages, either human operations or operations controlled by the automation layer.

Using SIMATIC IT eBR ensures the reli-able acquisition of critical process data. It allows forward and backward searches through genealogy and audit trail tools. In this way, it significantly reduces manufacturing, review, and release times and enables faster time to market.

Features• New application server architecture

• Improved touch screen execution cockpit

• New electronic batch report content and rendering

• Client installation simplified

• Compatibility with GS1 and extensi-bility of bar codes interactions

• Bug fixes and technological updates

Version 6.1 SP3 of SIMATIC IT eBR is a functional enhancement of the previous SIMATIC IT eBR version 6.1 and 6.0 (based on former XFP solution):

New features in SIMATIC IT eBR 6.1 SP3:

• New application server architecture with web console administration

− The new application server architec-ture allows a more precise configuration of multiple and distributed Windows services, enabling native support of redun-dancy and load balancing throughout the entire application servers range. A new web console provides the capacity to adminis-trate services from any network workstation in real time

• Improved touch screen execution cockpit

− The standard execution cockpit is enhanced to improve the end-user experience on touch screens and tablet-like form factors. Access to all functions is facilitated through a clarified ribbon and reworked buttons

Figure 2: Improved touch screen execution cockpit

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• New electronic batch report content and rendering

− The standard electronic batch report provided by SIMATIC IT eBR is completely reworked. The content of the report is improved and extended to enrich the information provided during every step of the production. New embedded PDF attachments (including execution report, weighing and dispense report, annexes attached during the process and any custom reports developed during projects) are encapsulated with a new cleaned header in a comprehensive PDF document. This document is prer-endered through a background service which allows the generation of a 1,000 electronic page docu-ment within seconds. In addition, the system allows for some tasks to be excluded from the electronic batch report, offering different levels of lecture of the report

• Client installation simplified − SIMATIC IT eBR client installation has been simplified by providing the light Oracle® client deployment packages, which avoids the installa-tion of the Oracle client part

• Compatibility with GS1 and extensi-bility of barcode interactions

− The system now accepts applica-tion-wide new barcode format defined by the GS1 DataBar stan-dard which allows complex (multi-information) barcodes. In addition, the barcode recognition can be extended or customized to cover specific customer cases.

• Many other features: − Possibility to import/export between hotfix release

− New tool for electronic work instructions analysis

− New access rights for packaging operations

− Direct access to master batch record from eBR review cockpit

Figures 3-5: New electronic batch report content and rendering

Distinct features of SIMATIC IT eBR 6.1• MBR module to simplify critical pro-

cess parameters management, providing synthetic eBR report com-paring execution and master data, with management of bill-of-materials (BOM) (formula)

• Native integration with 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 control designed to be inte-grated in human machine interface (HMI) system (WinCC)

• Project Startup package including label template, scripts and standard query language (SQL) queries to create reports or key performance indicators (KPI) on standard data

• Support of unicode character encoding

• Generation and attachment of a document to an electronic batch record

• Fifteen weighing modes, including a new one to perform weighing with a graduated cylinder as a virtual scale

• Improved configuration of electronic signatures to facilitate the manage-ment of a single check, a double check or a conditional check after a manufacturing operation such as weighing

• New management of expiry dates based on opening time (shelf life)

• High availability for shop floor connections

• Windows CE-based unicode client for warehouse operations on radio fre-quency terminals

• Client installation simplified

• Bug fixes and technological updates

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Figure 6: Compatibility with GS1 extensibility of barcodes interactions