PAS-X SOFTWARE BUSINESS FUNCTIONS

Transcription

1 PAS-X SOFTWARE BUSINESS FUNCTIONS

2 PAS-X Business Functions The business functions provided by PAS-X cover all areas related to specification, manufacturing control, quality assurance, and process optimization. The functional architecture of PAS-X closely follows the ANSI/ISA 95 standard. SPECIFICATION Process Development IMP Manufacturing Master Batch Records EXECUTION Finite Scheduling Weighing & Dispensing Electronic Batch Recording Equipment Management Material Flow & Inventory Warehouse Management COMPLIANCE Process Quality Control Track & Trace Serialization Aggregation PERFORMANCE Manufacturing Intelligence 2

3 A tailored Start-up Process PAS-X offers you flexible, scalable product configurations to cover your specific needs. The incremental step-by-step deployment approach secures your investment and allows money and time spent on individual projects to be evaluated precisely. Based on the business functions provided by the PAS-X product, we have designed various tailored packages for you. Start-up Packages Start-up Packages are small-scale packages focusing on a specific functionality. These startup packages can be upgraded. Start with a small solution and extend it on a step-by-step basis - up to a functionally complete full-scope MES system. 3

4 Proccess Development IMP Manufacturing Accelerated development and scale-up of manufacturing processes PAS-X Process Development simplifies and speeds up the modeling of manufacturing processes for pre-clinical and clinical production. It is available as a standalone product or an integrated Business Function of Werum s PAS-X Manufacturing IT Business Platform. PROCESS DEVELOPMENT Laboratory Pre-Clinical Production Clinical/IMP Production Launch & Commercial Production Flexible & Open Workflows TECHNICAL BATCHES Process Design CLINICAL BATCHES Process Scale-up Guided Workflows Fine Chemicals Biopharma Blood Plasma Vaccines Liquids Solids FASTER TIME TO MARKET The goals and drivers of PAS-X with respect to process development are as follows: Business Accelerated and enhanced MBR development, MBR validation and batch record review High process visibility due to a single system for all stages Agile response to changing clinical trials demands High flexibility while maintaining GMP-compliant status Knowledge transfer Simplified transfer of processes from development stage to commercial production using structured information Supporting an open, flexible approach for development of technical batches Collection of all GMP-relevant data Predefined library elements to accelerate scale-up process ensuring flexibility and observing compliance requirements Supporting a collaborative approach Allowing on-the-fly definition of the batch record structure at early development stages 4

5 Process development Integrated Design of Experiments (DoE) features Reliable identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) Enabling Quality by Design (QbD) Why PAS-X Process Development? Fast and flexible MBR development Seamless knowledge transfer from development to commercial production High degree of flexibility in early-stage batch recording DoE approach for CPP and CQA identification to enable QbD Improved process visibility, data analysis and information transfer 5

6 Master Batch Records Structured Management of Master Batch Records Master Batch Records (MBRs) are general manufacturing instructions. Batch Records are derived from them and refer to a specific order. Master batch records and batch records are therefore the basis for a precise and detailed description of pharmaceutical manufacturing processes. They contain all pharmaceutically relevant data: the input material list, valid SOPs, detailed work instructions to be applied in production, and also process data, or process steps, such as in-process controls (IPCs), Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). Even today, conventional word processing systems are often used to create and maintain master batch records and batch records. The final result is paper documentation. It really is an uphill struggle: Time-consuming and error-prone manual reconciliation or approval procedures are required to carry out tasks like structuring, maintaining and managing versions of master batch records for reconciling data with the ERP system. Master Batch Records, by contrast, is based on structured master batch records which are subject to automatic version management and which use libraries with reusable building blocks. The use of standardized building blocks makes it much easier for the user to create and maintain master batch records. In particular, PAS-X also administers those recipe elements which are specific to interfaced process control systems (DCS/SCADA). An integration layer that is independent from the actual control system enables the general definition of recipes, which are then implemented in a way suiting the specific control system used. Master Batch Records structured by means of predefined Building Blocks Master Batch Records maps master batch records as graphical structures: Master Batch Records allows the user to set up libraries with standardized, reusable building blocks which can then be used to create a master batch record. These building blocks are subject to version management. Master batch records are defined and displayed using a graphical design tool. The applied master batch record structure meets the requirements of the ANSI/ISA 88 / 95 standards. 6

7 Parameterization of Unit Procedures for Automation and Process Control Systems In fully automated production environments, the standardization of production recipes is moved to level 3 of the S95 model. Thus, the MES becomes the leading system for the definition of recipes while these are actually executed at the level of the process control system. The relevant data tags can be managed as logical or physical tags. Master Batch Records is an intelligent Business Function When master batch records are created, Master Batch Records carries out defined checks to ensure plausibility and completeness. For this purpose, it is possible to set the parameters for more than 50 different test criteria. For instance, it can be checked whether the recipe specifies the required target values for the process. If specifications are missing at any point, the system will display a message to the user. Master Batch Records calculates material quantities across entire MBRs and lists totals of all input material quantities in BOMs. Yield calculations are also taken into account, as they permit the drawing up of the requested material balance sheets. 7

8 Electronic Approval Workflows Master Batch Records supports all workflows necessary for review and approval. The system will notify all peopled concerned by and then deliver the required documents in electronic form directly to the relevant user s desk. Any corrections and changes to the master batch records are made and documented within the system itself. Electronic signatures are used to sign approvals in compliance with 21 CFR Part 11. Master Batch Records facilitates and simplifies workflows, shortening approval cycles and therefore drastically reducing associated documentation work. Integration with ERP Systems Master Batch Records provides standard interfaces to all leading ERP systems. By means of configuration, Master Batch Records can be adjusted to the requirements for different ERP systems. Depending on the specific ERP system, the contents will be simple bills of material or routing structures. When generating orders, Master Batch Records will fill in missing information and maintain it in FDA/GMP-compliant manner. This business function thus offers an essential benefit in the context of software system validation: Master Batch Records business function includes all software functions which are subject to validation and can therefore be validated as master system for the creation of master batch records. It is no longer necessary to carry out additional validation for the higher-level ERP system, which would be costly and time-consuming. 8

9 Finite Scheduling Shop Floor Scheduling Finite Scheduling is a PAS-X business function that enables detailed scheduling of production processes. Since it includes functions for checking material availability and controlling order processing, it is an ideal complement to the ERP system, adding specific shop floor scheduling functionality. Finite Scheduling is highly scaleable and easy to expand. Its functionality ranges from simple to complex. For example, it has uncomplicated, clear, well-arranged graphics, which map the current order status to a chart and allow the user to take manual control. It also offers complex intelligent algorithm-supported production scheduling features. Finite Scheduling adds more shop floor scheduling and control functionality to an ERP system s production planning functionality. Graphic planning boards provide a quick overview of the most important scheduling details; they help the user visualize and optimize complex relationships and make it easier to modify order scenarios down to the shop floor level. Finite Scheduling has a modular structure. This gives the schedulers the flexibility they need to decide by how much they want the software to support them in planning the production process. Order Control 9

10 For the purpose of detailed production planning, Finite Scheduling uses the specifications defined in the ERP system. Finite Scheduling can either directly access the master batch records managed and maintained in the Master Batch Records business function or retrieve routings from the ERP system. If these routings already contain production planning details, Finite Scheduling adopts the orders in corresponding sequence using certified interfaces. The scheduler can then optimize them for the production process by means of the provided simulation and finite scheduling functions. The scheduler can use the simulation functions to develop several production scenarios and to compare them to one another. Graphic evaluation functions create the basis for selecting the most favorable production model. In the context of detailed planning, Finite Scheduling considers marginal conditions which previous production planning operations have not taken into account. Some of these conditions are: - capacities of systems, machines and staff - production preparation times - downtimes and maintenance periods - set-up and cleaning times - product compatibilities - material availabilities - information on material status - release periods Materials Planning The Materials Planning business sub-function provides the option to integrate material usage and material availability checks into the scheduling process. In this context, the focus is on production-integrated scheduling. Finite Scheduling supports the planning operations for material staging and for controlling material replenishment. This functionality is of special importance for production environments requiring large quantities of material. Usually, long-term stockpiling of such materials is not possible and such materials must be delivered just-in-time for use. The periods required to approve raw materials and semi-finished products additionally affect the planning process. They are taken into account in the production-based material availability check. 10

11 Planning Cockpit The most important feature in production scheduling is a constant feedback from the manufacturing process. In a continuous actual-to-target value comparison, Finite Scheduling compares the planned production situation to the actual situation. Malfunctions may affect schedules, bottleneck resources and delays in productions. Instantaneous feedback from the shop floor level based on recorded process data, such as malfunctions, enables the scheduler to take necessary actions at an early stage, whenever necessary. Transparent Planning Process The PAS-X Workplace Concept provides workplace-related dialogs tailored to all users and their individual scope of duties. In addition, anyone involved in the production process, be it supervisors or production managers, can directly view the current status of production scheduling. Of course, PAS-X can also make the same information available to an extended group of people, e.g. the sales & marketing team. Thus, the system provides all employees with information that is relevant to them personally. Evaluations Finite Scheduling provides standardized evaluations to enable optimized production scheduling, such as: - product-oriented evaluations - machine-oriented evaluations - capacity evaluations - stock-oriented evaluations Open interfaces enable an export of the scheduling data to Analysis Tools for the purpose of additional, individual evaluations. 11

12 Weighing & Dispensing The PAS-X Business Function for Weighing & Dispensing The precise Weighing & Dispensing of input materials based on recipe specifications is at the core of any pharmaceutical manufacturing process. Accurate data collection within this first processing step is fundamental to batch tracking and documentation. In a reliable and easy-to-operate way, the Weighing & Dispensing system guides the user through the weighing process and provides the necessary support for compliance with safety regulations and recipes. Weighing & Dispensing - Guides the operator through the entire weighing process with user-friendly electronic work instructions on the screen - Controls any kind of weighing operation including manual and automated weighing, dispensing and filling processes - and thus increases the quality of the weighing process - Enables automatic campaign building and execution - Generates complete labels according to customer-specific parameters - Carries out plausibility checks on materials, containers and scales through barcode identification - Monitors and supports the calibration of scales and sets up a scale logbook - Supports the interfaces of all commercially available scale manufacturers - Documents and archives data in accordance with GxP/FDA regulations for electronic records and electronic signatures (21 CFR Part 11 compliant) - Generates weighing reports and - Maintains audit trails 12

13 Manual Weighing In the case of manual weighing operations Weighing & Dispensing guides the user through graphic operating dialogs, regardless of the type of scale. Workflows for material and container identification are defined within the weighing instructions and can easily be adjusted to individual business processes simply by changing parameters. Source: Genzyme The use of mobile radio terminals for weighing procedures ensures a high level of operator mobility. Operators can make use of wireless barcode scan features to work in parallel at several work centers following easy-to-operate dialog instructions. Weighing & Dispensing ensures that all workflows are carried out accurately and correctly, and it prevents the kind of mix-ups and errors common to manual data entries. Automated Weighing & Dispensing Operations Weighing & Dispensing supports automated dispensing and filling systems, and provides standardized interfaces to PLC systems and dispensing control systems. Interfaced with the ERP system the system administers bills of material and recipe parameters. These order-based data are processed, documented and logged at all weighing stations. Werum s longstanding expertise in the integration of automated systems ensures successful equipment integration for all the different types of system components, even within explosion-proof areas. Material Identification Weighing & Dispensing ensures that the specified input materials are actually used. It therefore controls automated or manual reading and identification operations which can be based on barcode labels and transponders. Weighing & Dispensing then checks the data against the specifications in the shop floor order. Source: Schering-Plough 13

14 Electronic Batch Recording Electronic Execution and Documentation of Batches Efficient electronic and thus paperless batch documentation is one of the core objectives in introducing Manufacturing Execution Systems in pharmaceutical production. In this, special attention must be paid to the regulations of 21 CFR Part 11 Electronic Records; Electronic Signatures. With the Electronic Batch Recording function of PAS-X master batch records are electronically executed and the processes and results are documented in compliance with the applicable statutory provisions. PAS-X ensures an error-free execution of the entire production process. Easy-To-Operate User Prompting Electronic Batch Recording offers user-friendly, standardized operating dialogs for the whole production process. It covers all stages, such as the receiving of incoming goods, production and packaging operations through to the shipping of finished products. The user interface is graphical, but the system also visualizes batch records on screen in a paper-like fashion ( Paper on Glass ). Rules Enforcement throughout the Process The batch record displayed on screen includes all work instructions as they are required. So, the user for example finds bills of input materials with complex formulas for value calculation or specifications on individual process parameters like limiting values for the temperature. Even complete Standard Operation Procedures (SOP) can be displayed on screen in their latest released versions when interfaced with a document management system. With displays in bold red/yellow/green traffic signal fashion as well as dedicated role-based dialogs, PAS-X ensures intuitive and ergonomic working for the user. 14

15 Role-based Workplace Concept Following a role-based workplace concept, PAS-X provides different optimized user display modes and dialogs reflecting a user group s specific role in the production process. This means that various types of user interfaces are available for executing electronic batch records: - Industrial PCs - Mobile terminals - PDAs - Mobile notepads with touch-screens The use of Radio Frequency (RF) capable mobile terminals and notepads with integrated scanners allows for maximum flexibility and freedom of movement. The work instructions as well as material plausibility checks based on scanner input can be accessed by every user at any place and at any required time. Process Data View A Distributed Control System (DCS) or Supervisory Control and Data Acquisition System (SCA- DA) may be employed to control the process. In this case, the role-based workplace concept of PAS-X offers integrated visualization of electronic work instructions and process data. This way, the user obtains a homogenous picture of the process state. 15

16 Equipment Integration By integrating pharmaceutical process equipment via standardized interfaces PAS-X is able to exploit all relevant data of the equipment level: - Electronic Records / Electronic Signatures in compliance with 21 CFR Part 11 (for documentation/archiving purposes), - Specifications/download of recipe parameters to the machine, - Operating state data, - Operational time accounts, and - Malfunction data and periods. PAS-X archives all process data in a 21 CFR Part 11-compliant way, with a particular focus on CQAs and CPPs. All logged process data are thus available for evaluations and as a basis for identifying the potential for optimization. (Manufacturing Intelligence) Deviation Handling During execution on shop floor level, Electronic Batch Recording continuously compares the captured ACTUAL data to the SET values set forth by the batch record. In the event of a deviation, the system immediately displays a traffic-light alert at the quality control panel. The representation in red/yellow/green color enables corrective user intervention into the process in good time. These and other deviation handling functions further enhance the broad PAS-X portfolio and form a solid foundation for comprehensive deviation management. 16

17 Material Flow Control Electronic Batch Recording documents all materials used in course of the production process. At the time of input, the system identifies and verifies the input materials using the connected barcode readers or transponders. In combination with the material flow control component of PAS-X, it also enables control of all material transports with integrated container management and facilitates integration with Automatic Guided Vehicles (AGVs) or pallet handling systems. Audit Trail Electronic data that is produced during execution on the shop floor (Electronic Records and Electronic Signatures) is documented in accordance with the requirements of 21 CFR Part 11. Electronic Batch Record featuring a Deviation Report The electronic batch record summarizes the data to provide it in consolidated form for easy and effective review at a PC saving a lot of time. Electronic Batch Recording also creates a separate report on deviations. At a single glance, the persons in charge can grasp and assess all information relevant to approval or rejection. The approval workflow can be configured in a flexible fashion and define several persons and departments to be in charge. 17

18 Batch Tracking with Graphical Batch Tree The batch data captured throughout the production process is placed available in the Compliant Historian Database of PAS-X for later analysis. To enable easy access, all pharmaceutically relevant batch data and its links to other information is arranged in a graphical batch tree. Moreover, there are standardized search functions helping the user to find specific batch information. 18

19 Equipment Management Electronic Equipment Logbooks Equipment Management uses as an example the Container Management business subfunction to administer and monitor the status of containers, receptacles and pallets. The system keeps status lists, cleaning rules and histories for the individual container types in the form of detailed logbooks. During the weighing operation a plausibility check is carried out to ensure the suitability of source and target containers. The container management component checks that the containers which are being used meet the set requirements. Usually, barcodes or transponders are used to ensure reliable container identification. A comprehensive set of master data is allocated to each container, and includes data on tare administration, complex rules for cleaning or sterilizing, product compatibility and possible product sequences. Equipment Management checks containers prior to their use, e.g. for cleaning status and usability. Equipment Management has much more to offer though. It administers cleaning procedures for all types of production-related objects, including master batch records and particular rules for cleaning scales, work rooms, containers, production equipment and setup parts as well as toolkits. Even complex rules for sterilization and associated sterility expiration dates after cleaning operations can be managed and monitored. With Equipment Management, it is possible to control the assembling of individual equipment modules into complex units and to use these complex units in the production process. In this context, Equipment Management monitors and documents counter values and authorized, parameterizable equipment statuses and status changes. 19

20 Material Flow & Inventory In-plant Material Flow One of the essential core functions of PAS-X is to secure in-plant material flow throughout the pharmaceutical production process. The PAS-X business function Material Flow & Inventory is made up of modules. It contains business subfunctions for manual and automatic transport control as well as in-plant administration of shop floor storage areas. The business subfunctions for transport control cover the complete material flow, from goods receipt, to quality control, to production, through to packaging, order picking and shipments. By adding shop-floor-related functions for material flow control, Material Flow & Inventory is an ideal complement to the material management functionality of classical ERP systems. For example, it provides mobile terminals that support every transport and walk the operator through the entire transport process. Material Identification Material Flow & Inventory ensures that the materials used in pharmaceutical production are uniquely identified on receipt by means of barcodes or transponders. The system supports a multi-step identification concept, which starts with the labeling of pallets, including pallet documents, and reaches down to single handling units. Transport Control Source: Schering Plough Material Flow & Inventory supports flexible mapping of the entire material flow in production and facilitates more efficient transport control procedures. All in-plant material movements are logged in an audit trail. Through its tracking function, Material Flow & Inventory supports uninterrupted tracking of the entire material flow. Standard information functions provide details about material quantities, available batches, batch qualities, and storage locations. At all times, users have access to the necessary work instructions and transport information via stationary computers or mobile radio terminals. 20

21 Cold Chain Monitoring Special functions, such as cold chain monitoring for temperature-sensitive products, round off the range of functions offered by Material Flow & Inventory. Production Line Supply Material Flow & Inventory uses the Order Picking business subfunction to compile input materials for production (line supply). In other words the software is able to supply the packaging lines, for example, with the required packaging materials. Material Flow & Inventory also supports automatic control of material replenishment for production lines, particularly for large batches which have to be supplied in several steps. Automated Transport Systems Material Flow & Inventory also offers specific business subfunction which enable easy configuration of different systems for transport control: - automatic guided vehicles - roller conveyors - overhead conveyors Forklift Control Systems Material Flow & Inventory also includes a Forklift Control business subfunction to establish transport control features for forklifts. The transport orders are communicated to the forklift through radio transmission. Pending orders are displayed to the driver on mobile terminals or forkliftmounted terminals with a touch-screen. Computer-supported forklift activities increase transport safety and efficiency of material flow operations. Even when a large number of forklifts is interfaced to the MES, the system still stands out and operates with a high degree of transparency and efficiency. 21

22 Warehouse Management In-plant Warehouse Logistics The PAS-X Warehouse Management business function supports production-related warehouse logistics. The system components can be configured as required, and form the basis for implementing - Warehouse managements systems - High-bay warehouse control systems - Forklift control systems - Order picking systems - Computer-aided pick systems (e.g. pick-to-light) These systems are specifically designed to meet the requirements of the regulated batchoriented industries. Warehouse Management Systems Use Warehouse Management to configure and parameterize your storage locations and bins. The system supports you in operating - High-bay warehouses: fully automated, semi-automated, or manual - Bin-based storage locations - Storage locations for tanks - Storage locations for silos Order Picking Systems Warehouse Management comes with a number of different configurable system components for order picking. 22

23 Order Picking for Production Floor Warehouse Management deals with the material requests for production, e.g., for manufacturing or packaging. This business function provides special picking functions, which may also be implemented mobile terminals to facilitate flexible processing of the goods. For subsequent transports, e.g., to the production floor, a transport order is initiated and processed. This guarantees that the required materials are ready for use in production at the scheduled time. Picking and Shipping Warehouse Management can also handle the shipping of finished goods. In this case, processing of the picking lists and staging of the goods for shipment is a joint task of the Warehouse Management business function and an interfaced ERP system. Goods Issue The system provides comprehensive functions to render assistance in order picking transactions involving large components, such as big bags and whole pallets, as well as smaller individual handling units. Computer-aided Pick Systems To meet the special order picking requirements for small items, Warehouse Management enables the configuration of computer-aided pick systems. These pick systems will usually consist of picking racks or, alternatively, can be configured to guide the staff through the picking order on mobile terminals. Transparent Warehouse Management, Transport Control and Operator Guidance Our warehouse and logistics systems have open ERP interfaces, which have already been connected to various ERP systems. In particular, we offer certified interfaces for SAP systems, which ensure transparency of your warehouse management, transport control, and operator prompting. 23

24 Process Quality Control Continuous Quality Control during the Manufacturing Process Quality control is of vital importance during the manufacturing process. Its objective is the continuous control and improvement of product quality. The Process Quality Control business function offers you the PAS-X functionality that ensures a continuous monitoring of the production quality. With this business function, you can process any deviations from the specifications during ongoing manufacturing operations. But, more importantly, you can use functions that support process-analytical on-line, in-line, and atline quality controls to take preventative and flexible measures in order to achieve the highest possible quality. Process Quality Control supports you as you implement Process Analytical Technology (PAT) and state-of-the-art Quality by Design (QbD) concepts. Quality Control Dashboard Process Quality Control supports qualified persons in their daily work. Quality Control Dashboards can be configured in flexible ways to show deviations in the different manufacturing and packaging sectors on intuitive traffic light displays. The qualified person can directly intervene, down to the batch record level, evaluate deviations with appropriate audit trails, and take appropriate measures - all with a simple mouse click. Deviations are actively displayed. You don t have to hunt for them. Deviations / events may directly initiate a CAPA process in an external system, e.g., Trackwise. Standard interfaces to the CAPA system are available out-of-the-box (OOB). 24

25 Electronic Batch Recording as the Basis The step towards paperless documentation is a milestone on the path towards more reliability and documentation quality in the pharmaceutical manufacturing sector. Electronic user prompting guides the operator securely through all production steps of the manufacturing process. Process Quality Control is a logical and consistent add-on to the Electronic Batch Recording business function. Process Quality Control, with its core function of workflow-based deviation management, makes good use of all the benefits of Electronic Batch Recording, and it safely controls all critical parameters. 25

26 Automated Deviation Tracking With the help of the Electronic Batch Recording business function, all set values and tolerance bands are uniquely specified within the process, and are electronically verified. On recognition of deviations, Process Quality Control informs the operator and prompts for a response. The electronic early warning mechanisms in Process Quality Control enable the user to take corrective action regarding the production process the moment any negative trend is recorded. Every single deviation is documented. 26

27 Classifying Deviations The system prompts the operator to classify recorded deviations and to add a comment. At the same time, Process Quality Control checks whether a second electronic signature is required. The criteria for required second signatures can be customized within the system. Furthermore, subsequent actions can be parameterized. The system can therefore, for example, in the case of defined deviations, prompt the operator to notify the supervisor in charge before continuing with the process. Analyzing Deviations An electronic workflow ensures that deviations can be evaluated by different members of staff and various departments. This method delivers two vital benefits: On the one hand, time-consuming distribution of paper documents becomes redundant; on the other hand, target and actual process data, required for evaluation, are made readily available. Evaluating Deviations Process Quality Control creates an electronic Deviation Report for the Electronic Batch Record. The deviation report is part of the electronic batch record. A condensed report of all deviations allows the batch record to be released efficiently and with no unnecessary delays. The release process is controlled by a parameterizable electronic document workflow. Audit Trail Once reported and evaluated, the deviations are stored within an audit trail. The system documents electronic signatures in compliance with the 21 CFR Part 11 requirements. Process Quality Control therefore improves the performance of all release processes and, at the same time, fulfils compliance regulations regarding the documented pharmaceutical release process. 27

28 Track & Trace Serialization Aggregation In close collaboration with its partners, Werum has developed a Track & Trace solution for the pharmaceutical industry to comply with anticounterfeiting requirements for medical drugs. PAS-X Track & Trace provides serialization and aggregation functionality for packaging processes and integrates the ERP and the Global Repository with the shop floor packaging equipment and line controllers. Secure Track & Trace System Capabilities Tracking is the process of monitoring products, by means of a secure marker (identifier), as they make their way to the consumer. In this way, a time and location history is built for each product. Tracing is the concept of being able to intercept and authenticate products and trace their route back to the manufacturer. In this way, the time and location history of a specific product is retrieved. Serialization is the unique identification of a medical product to avoid drug counterfeiting via printing a unique serialization number on packaging units e.g. 2D barcode, RFID tag PAS-X Track & Trace Key Functionalities Support of GS1 labeling information Management of modular packaging line layout incl. print layout recipe management Management of serialization numbers in operations Management of modular aggregation for e.g. item, bundle, pallets Integration with centralized Track & Trace repositories using standards like EPCIS Handling of packaging orders and batch information Handling of mass data for serialization and aggregation processes: Dialogs to create, discard, aggregate and disaggregate units and hierarchies User management incl. rights management & audit trail Generation, randomization of serial numbers Support of multiple serial number formats e.g. SGTIN-96 Providing serial number blocks to packaging lines Recording and reconciliation of used and unused serialization numbers Packaging Line Performance Management Out of the Box using T&T connectivity Analysis of OEE (Overall Equipment Effectiveness) for packaging processes 28

29 PAS-X Track & Trace - Systemarchitektur LEVEL 4 ERP System Central Repository SAP Certified Integration with SAP Applications LEVEL 3 Packaging Solution LEVEL 0-2 Line Controller Manual Packaging 21 CFR Part 11 and Electronic Product Code Information Services (EPCIS) compliant Support of EPC Tag Data Standard for electronic product coding, e.g. SSCC, GTIN Standard interfaces: Line Controller: Uhlmann, Seidenader, Systech International, etc. ERP Systems: SAP, ORACLE, etc. Central Repositories: SAP (Auto-Id Infrastructure AII, Object Event Repository OER), IBM (Info Sphere Traceability Server ISTS, Websphere Sensor Events WSE), Axway Track & Trace Standalone system or integrated MES Business Function Multiple language/unicode support Why PAS-X Track & Trace? Independent of ERP systems and line controllers Rich product-based functionality Out of the Box Covering global anti-counterfeiting requirements Analysis of OEE 29

30 Regulatory requirements and deadlines - worldwide 30

31 Manufacturing Intelligence Performance Management in Manufacturing Data collected during manufacturing processes is valuable, in particular with regard to GMP requirements, i. e. in the archiving of electronic batch records and in helping to identify areas where the manufacturing process can be optimized. In order to be useful, however, this data needs to be processed and analyzed in a suitable format. Manufacturing Intelligence is a PAS-X business function which helps you to access manufacturing data and assess it to enhance performance within your manufacturing processes. Manufacturing Intelligence gives you business subfunctions as a basis for using specific criteria to assess and evaluate your production processes, map them graphically, analyze them, and optimize them to suit your specific requirements. Werum offers access to the data through a number of different tools and for a variety of use cases - for simple, printable reports all the way through to complex MII-based information portals. The foundation for this is the transparent PAS-X data model to which the user has access through different configurable methods. Reporting The transparent data model enables the user to access the data in PAS-X. The Crystal Reports tool facilitates easy design and generation of reports. Our standard PAS-X delivery, which varies according to the business functions used, contains preconfigured reports. Once you are trained to work with Crystal Reports, you can modify these standard reports and adjust them to your needs. You can also generate completely new reports using the Crystal Reports Engine. Performance Package The evaluation package incorporated into Manufacturing Intelligence: provides you with predefined evaluations based on PAS-X standard data models without the need for any configuration on your part. For example, you can generate overview charts on materials, deviations or process data for your manufacturing or packaging operations. Visual representation of the evaluation data in the form of diagrams makes it much easier to understand correlations, trends, and results, and thus increases transparency in the pharmaceutical manufacturing process. The performance function of Manufacturing Intelligence: is preconfigured and based on Qlik- View software by QlikTech International AB. Quick implementation and intuitive operation are among the most significant advantages of this software solution. Based on the standard PAS-X data model, this evaluation package provides you with evaluations on the most important manufacturing data. 31

32 Through mouse click, the end user can display the evaluations in graphical form. Special standard functions make it easy for the user to filter out the relevant data from the comprehensive data model and display it in a chart. KPI Feature Package: Decision-Making Tool for Operational Excellence The KPI Feature Package provides powerful functions for ensuring operational excellence and lean manufacturing using PAS-X data for performance management. The KPI Feature Package automatically acquires and evaluates all operating data on shop floor monitors in real time thus turning data into key figures to aid decisions. Operators and supervisors can view the current status of the packaging lines at any time. If data is not provided by the equipment, the KPI Feature Package also allows operators to manually enter the causes of interruptions, such as setup times, pausing times or maintenance. This enables a gapless 100% 65% 65% 98% 32

33 Preconfigured KPIs such as Overall Equipment Effectiveness (OEE), Capability and Availability support transparent processes both for operators and the management. These KPIs can be made available in standard reports immediately. The preconfigured and certified PAS-X standard interfaces guarantee a seamless data exchange with the shop floor equipment. Why KPI Feature Package Manufacturing intelligence tool Real-time data acquisition and evaluation Delivery of key figures to aid decisions Continuous improvements ensured Integrated and transparent data access across levels and systems Key Benefits Management: Reduction of costs factors driving costs such as bottlenecks and reasons for equipment downtimes can be identified easily. Operator: Saving of time data for performance management is available immediately enabling the operator to focus on the production workflows. Administration: Ease of configuration all functions and data are available within a single system. 33

34 Integration with SAP MII and other BI solutions When interfaced with business intelligence (BI) solutions, Manufacturing Intelligence offers further options for determining global key performance indicators (KPI). This is enabled by the open interface external data model of PAS-X. Reporting tools such as SAP MII, SAP Business Objects, IBM Cognos or SAP Crystal Reports can thus use data from PAS-X for extensive reporting and evaluations across systems and facilities in a global network. Easy Integration - Maximum Benefit Data evaluation with Manufacturing Intelligence provides transparency and enables objective assessment, both of which eventually lead to optimization of your business processes. Simple and individual configuration of key operating indicators to your own specifications allows for highly flexible use of your MES system. Manufacturing Intelligence: It pays! M4EN3 34