HIGHLIGHTS BATCH AND SERIAL NUMBER MANAGEMENT QUALITY CONTROL VENDOR RATING ELECTRONIC SIGNATURE AND AUDIT TRAIL R&D MODULE MANAGEMENT OF ACTIVE INGREDIENTS SEQUENCE PLANNING MOBILE SCANNER INTEGRATION
PAGE 2 With its industry solution Tectura Life Sciences based on Microsoft Dynamics NAV, Tectura provides industrial and trading companies from the pharmaceuticals, fine chemicals, cosmetics, biotechnology, medical technology, and dietary supplement industries with a solution designed to meet the requirements of the industry and its regulatory requirements. The Tectura Life Sciences solution was developed in combination with both industry experts and industry users resulting in a commercially available application that addresses their unique and specific requirements. Built using technology standards and leveraged to meet industry specifications - Tectura Life Sciences covers all areas of business: from Purchasing, Sales, Production, Accounting, Quality Control Systems, Vendor Rating, Raw Material Data Management, Laboratory Systems, Resource Management, and Logistics, to Marketing and Distribution. HIGHLY INTEGRATED ERP INDUSTRY SOFTWARE BASED ON MICROSOFT TECHNOLOGY The industry solution Life Sciences, like all the solutions from Tectura, has been created according to the development guidelines of Microsoft Dynamics. This fact guarantees programming that is correct and fit for release and includes extensive online help. This ensures maximum investment security. PROJECT METHOD AND VALIDATION In the pharmaceuticals industry and increasingly also in other areas of the Life Sciences industry, the regulatory demands on computerized systems that serve the manufacture, storage, and distribution of products in a regulated environment are being extended. Tectura provides an efficient and proven implementation methodology for your company. In cooperation with partners for validation, the Tectura implementation method, which is oriented on GMP guidelines, has been further developed. Right from the start, the system introduction is defined by a process-oriented procedure that corresponds with the corporate governance in this industry. The process orientation in the introduction not only facilitates an easier validation of the implemented solution, but is helpful for all companies that want to check the quality and safety of their business processes. The procedure is completely tuned to the product Tectura Life Sciences. In this way, the expense for preparation of the required validation documents can be considerably reduced. WITHIN THE FRAMEWORK OF A SUCCESSFULLY VALIDATED ERP INTRODUCTION, THE INDUSTRY SOLUTION AND THE PROJECT METHOD WON THE INTERNATIONAL LIFE SCIENCES MICROSOFT INNOVATION AWARD FOR 2007. In addition to the software, Tectura also supplies an extensive, system-near business process documentation, numerous templates, and Standard Operating Procedures (SOP s). The standard compliance of the industry solution and Tectura s internal quality management system have been tested in numerous audits by reputable pharmaceuticals manufacturers. So user companies do not just receive an outstanding solution, but, thanks to an intelligent change management, can keep it up to date with manageable expense. INDUSTRY SPECIFIC BASIC FUNCTIONALITY The seamless mapping of batch logistics and of lot and container management is a basic prerequisite for an IT business solution in the Life Sciences industry. Here, the lot and container management must be
PAGE 3 consistently integrated into the entire materials management system, so that the information that is important to this industry (such as lot status or expiry date, for example) is available in all modules, regardless of the process. The industry solution from Tectura fulfills these preconditions and offers a number of important extensions to Microsoft Dynamics NAV, for example: Continuous availability check at lot and container level Possibility of conditional lot release Administration of quarantine periods Multi-stage lot tracing with additional tracing of internal inventory movements and lot data changes (e.g., change of status or expiry date) Lot-splitting/batch-merging Integrated attribute administration for the classification/specification of articles, customers, suppliers, and lots Integrated text module for purchase, sales, and production (e.g., for production protocol or process instructions) Automatic generation of filling articles and filling BOM s THE INDUSTRY SOLUTION ESSENTIALLY PROVIDES THE FOLLOWING MODULES: Document Management The archiving of changed master data and movement data can be freely configured including the selection of sensitive master data fields. Work instructions, guidelines, etc., can be simultaneously administered in version and assignment by means of an additional module. External documents can be used in practically all modules and file formats (using their respective application programs). Quality Control As part of the integrated Labor Information Management System, the Quality Control module provides administration of test attributes, test plans, and test resources. Through the manual or automatic creation of test orders within the process chain (from goods receipt to production and goods dispatch), the required product quality is assured. As this module is also fully integrated in the Lot Management, lots that are under test are blocked from unauthorized use or considered differently for planning purposes in dependence on their respective status. Among other things, the Quality Control module features the following functions: Integrated test stringency regulation (skip-lot procedure) according to DIN ISO 2598 Automatic determination of number of samples Integration of documents in any format into the whole testing system Test resource management Retest functionality for batches Lot Tracing The Lot Tracing runs without media discontinuity. All movements and the use and the origin of a lot can be called up at the press of a button. Optionally, all internal inventory movements (e.g., order picking or the stock movements ) and changes to lot data (e.g., status change or change of expiry date) can also be traced. (SEE FIGURE 1) Data Security and Audit Trail For the easy verification of master data changes, the user is interrogated and checked to ensure his or her authorization to change this master data record. The four eye verification is used as a form of double check. Here, the data to be verified according to this principle can be freely selected. As opposed to the standard logic in Microsoft Dynamics NAV, access authorizations can even be granted for individual fields. The change verification fulfills the requirements of the electronic signature. Furthermore, all changes in the database are automatically documented
PAGE 4 by the existing Audit Trail functionality with time stamp, data, and user information, so that changes carried out can be ordered to the corresponding operation and tracked at any time. (SEE FIGURE 2) Production In the Production module, the entire lot logistics is maintained and continued. In the case of a production order, the lots are automatically assigned and, in the production, inherited in the processing, filling, or packaging processes. A single number lot production can be created and monitored. In addition, there is an extended lot expiry date calculation that takes different raw materials and lots into account. ACTIVE INGREDIENT MANAGEMENT AND QUANTITY CALCULATION Tectura Life Sciences offers a continuous Active Ingredient Management, from goods receipt to internal testing system and production. Within a manufacturing specification, in addition to the absolute percentage by weight or by volume, the required quality and/or the required active ingredient content can also be defined in order to achieve a uniform end product. This target value is the basis for the selection of batches in the production process. As the quality or active ingredient content in the raw materials used does not always correspond with the required target value in the manufacturing specification, the necessary input quantity of the respective raw material has to be calculated on the basis of its quality or its content of active ingredients. In order to achieve the final production quantity, in addition to the automatic calculation of active ingredient input quantities, the required quantity of auxiliary material (e.g., glucose) is also calculated by the system. (SEE FIGURE 3) MANUFACTURING SPECIFICATION Apart from the multi-stage determination of gross or net demand in Microsoft Dynamics NAV, the industry solution Tectura Life Sciences also offers many other planning functionalities to ensure cost optimized resource utilization in the production process. Thus, for example, with the help of the integrated sequence planning, taking account of freely definable planning parameters, a minimization of set-up times and optimum resource utilization and transparency can be achieved in the production. FIGURE 1: MULTI-LEVEL LOT TRACEABILITY FIGURE 2: CERTIFICATION OF MANUFACTURING SPECIFICATION WITH ELECTRONIC SIGNATURE FIGURE 3: INGREDIENT ASSIGNMENT FORM WITH AUTOMATIC INPUT QUANTITY CALCULATION
Delivering Quality, Safety, and Flexibility PAGE 5 Through the display of the inter-process or inter-departmental order network, disturbance variables such as lack of raw materials or insufficient machine capacities can be detected in good time. With the help of these control resources, delivery punctuality can also be optimized and stock inventories can be reduced. (SEE FIGURE 4) PRODUCTION PROTOCOL Batch size dependent Production Protocol can be created, in which parts lists and work operations from the process view can be generated in a mask. Furthermore, the free creation of work and process instructions is possible by means of an integrated text module directly in the Production Protocol. Naturally, the Manufacturing Specifications are version controlled and subject to strict password control. SALES Today, in most cases, the delivery or the whole order handling already represents part of the validation requirement. Over and above the standard of Microsoft Dynamics NAV, various reservation and order picking strategies can be optionally fulfilled. These also include sales restrictions due to legislation. Automatic batch assignment according to the FEFO principle (First Expired, First Out) or the definition of single batch deliveries is also possible. Various batch logistics functions, for example the definition of customer specific lot expiry dates, provide a maximum of functionality. ADDITIONAL FUNCTIONS Tectura provides optional modules and interfaces, which are available to supplement the industry solution. These include the integration of: Weighing Systems and Machines RFID Hazardous Substances Management Electronic Data Interchange Business Intelligence FIGURE 4: SEQUENCE PLANNING WITH TRAFFIC LIGHT WARNING SYSTEM 2009 Tectura Corporation. All rights reserved. Tectura is a registered trademark of Tectura Corporation. All other company, brand, and product names are marks of their respective holders. Version: 04.08