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SIMATIC IT UnilabIntegrated Quality Management

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SIMATIC IT, integrating quality

With SIMATIC IT, Siemens is broadening the scope of MES. Plant IT solutions must be based on a strong technology platform, compatible with the enterprise’s IT infrastructure, flexible and scalable at the same time.

But IT increasingly has to enable the integration of processes and systems across divisions and plants inside the organization, synchronizing manufacturing processes with business processes and complex supply chains.

The SIMATIC IT portfolio can cover these requirements offering the infrastructure to achieve the real-time enterprise for optimum market responsiveness.

• SIMATIC IT Production Suite is the plant-centric IT solution covering all manufacturing needs. SIMATIC IT Production Suite fills the gap between Business Systems (e.g. ERP) and Control Systems, creating the conditions for an efficiency increase at the plant and within supply chain operations

• SIMATIC IT Intelligence Suite makes the real-time enterprise possible, translating critical, real-time manufacturing information into business-level performance indicators.

• SIMATIC IT R&D Suite streamlines R&D and manufacturing processes and enables seamless transition of product data and definitions through the entire manufacturing process by integrating R&D data and workflows with the manufacturing environment.

SIMATIC IT Unilab is a key component of the R&D Suite but can also be implemented as a stand-alone quality management system.

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To efficiently ensure quality and regulatory compliance was always the very purpose of a lab in a nutshell, be it a QC lab, an R&D lab or a service lab. But the combination of strong market competition with an increasingly complex landscape of stringent regulatory requirements put an enormous pressure on manufacturers and production laboratories.

Their goal is not only to safeguard the brand name by ensuring overall product conformity and quality and meeting regulatory demands. The product innovations that are so crucial to the company’s success also find their roots in the lab.

The increasing amount of lab work involved must be handled by a rather decreasing lab workforce, and at the lowest possible cost.

On top of optimizing its own efficiency, the lab is also expected to largely contribute to business and production efficiency, helping improve processes and manufacturing techniques and reduce scrap and rework. This requires an integrated quality management system that can handle large quantities of quality data, covers all quality activities and supports the entire business process, improving not only lab efficiency but manufacturing efficiency as well.

Siemens understands these challenges and offers SIMATIC IT Unilab LIMS (Laboratory Information Management System), a solid and mature quality management system that can be implemented in smaller lab environments, or in multi-site and multi-language environments.

Leverage Lab Activities

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Capitalize on Quality

Much more than LIMS SIMATIC IT Unilab handles all quality is-sues and can be implemented as a stand-alone LIMS or as a part of SIMATIC IT (Manufacturing Execution System), but either way, it is fully compatible and integrated with any standard or home-grown ERP, MES, PLM and lab equipment, bridging the gap between lab and production. For the SAP users, SIMATIC IT Unilab has a certified interface with SAP.

SIMATIC IT Unilab is fully based on the ISA-95 industry standard’s Quality Operations model, offering comprehensive functionality. It manages quality in every aspect of the organization making it a key enabler to implement corporate (quality and brand) strategies and promoting collaboration throughout the enterprise. The modular, scalable structure of SIMATIC IT Unilab ensures a future-

proof “pay for what you need” approach, letting your quality management system grow with your company and your requirements.

Additionally, the exceptional configurability and standard templates drastically speed up implementation and limit the total cost of ownership and thus the total cost of quality.

Meeting customer requirementsSIMATIC IT Unilab is a leading LIMS solution. It was implemented successfully at a large number of multinational companies in process industries, as an independent LIMS or as the core of their quality management system.

In addition, SIMATIC IT Unilab is a tight fit for the environmental, animal health and water quality labs. It is also a key element of the SIMATIC IT R&D Suite which streamlines R&D

and manufacturing processes, and enables seamless transition of product data and definitions through the entire manufacturing process by integrating R&D data and workflows with the manufacturing environment.

A network of Siemens offices and strategic business partners backs up SIMATIC IT Unilab with the relevant skills and know-how, providing a complete range of services, such as training, support, implementation and validation.

Companies bracing themselves to efficiently handle a large variety of lab and quality data in ever increasing quantities will

find themselves in a position to leverage this lab efficiency and use all available quality data to improve overall product

conformity as well as manufacturing and business efficiency.

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Corporate architectureThe multilab concept of SIMATIC IT Unilab supports both a centralized or a distributed architecture providing one enterprise wide LIMS solution for all QC, service and R&D labs.

The high level of configurability, the User Management functionality and the embedded Graphical User Interface guarantee that every lab, department and user has a personalized environment tailored to their respective roles and preferences.

SIMATIC IT Unilab supports a web architecture with configurable, dynamic web screens allowing on-line data exchange between the lab and production operators, warehouse, suppliers, co-manufacturers, etc.SIMATIC IT Unilab is available in six languages.

Managing all quality data From quality checks of raw materials, in-termediate and finished products, over all sorts of analyses (environmental, compe-titor, ring, on-line, off-line, or R&D) to stability studies, SIMATIC IT Unilab ma-nages all types of analyses at multiple sites in multiple languages. All resulting data are stored in a structured way in the central quality repository, a relational and object-oriented database.

SIMATIC IT Unilab models and manages the complete workflow of all quality data in the lab and on the production line: samples, analyses, instruments, reports, and lab personnel, and offers a wide array of functionality and features to

cover quality management:• Time or event based sample Planning• Worklists and worksheet management• Verification and Validation• Trending and SQC• SOP support (Standard Operating

Procedures)• Instrument Connections (Uniconnect)• Audit trail and electronic signatures• Archive & Backup• Unicode and Multilanguage support• Advanced Web Functionality• Multi-time Zone and Multi-site support• Certified SAP Interface

User Authorization Management Data access based on site, department, etc. and functional access based on pro-file (QA, Lab Mgt, Analyst, etc.) and/or in-dividual.

Reporting SIMATIC IT REPORT MANAGER, the stan-dard reporting tool for all of the SIMATIC IT product family is an advanced web-enabled query, reporting and data analy-sis tool for data retrieval and manipulati-on in automated or ad-hoc reports. Thanks to the powerful and user-friendly data model no knowledge of query lan-guages is needed.

Validation PackIllustrates that SIMATIC IT Unilab was developed, encoded, reviewed and tested following a verifiable life cycle and includes a Certificate of Independent Audit.

Equipment ManagementCentralizes all information on each piece of equipment and supports calibration

and maintenance, including the required audit trail.

Qualification Management Centralizes all information on personnel to ensure appropriate certification and training.

Management by Exception and Alarm handling Lab workflow configuration to support automatic validation of in-spec analysis, leaving the lab supervisor the time to fo-cus on off-spec samples.

Barcoding SIMATIC IT Unilab can generate and defi-ne barcode labels for faster uploading and tracing of quality data.

Cost Calculation Module Automates the invoicing process for com-mercial labs by calculating the costs of an analysis based on price catalogs and pas-sing these to accounting.

Stability Module Detects the effect on quality of environ-mental influences such as temperature, humidity, and light. This helps determine storage conditions, retest periods, and shelf lives when new products, ingre-dients or dosage forms are introduced.

Hand-held devicesSIMATIC IT Unilab supports the use of tablet or pocket pc’s by mobile lab or production personnel to save time and avoid duplication errors.

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SIMATIC IT Unilab Benefits

Answering Questions SIMATIC IT Unilab enables fast exchange of quality information all along the pro-duction workflow covering multiple sites and involving different departments and making life easier for the various roles within the laboratory and production test environment.

Receiving dock: does the delivery meet this supplier’s specifications? Production: What material can be used? When do I send a sample to the lab? Is this batch ok for release? Shipping dock: Does this batch meet the customer’s specifications? Customer: Does this product meet my requirements? Certificate of analysis?

Regulatory ComplianceSIMATIC IT Unilab can help your laboratory comply with every major quality standard, such as GLP, GAMP, ISO 9001:2000, ISO 17025 and 21 CFR Part 11. SIMATIC IT Unilab manages and documents the full lab workflow and access control, providing electronic signatures and an audit trail. In addition, SIMATIC IT Unilab provides QA/QC specifications and manages and enforces methods and procedures centrally.

The modules for equipment management and qualification management guarantee that each analysis is performed by a qualified analyst on a calibrated instrument.

Direct connection of instruments to the LIMS guarantees that information required for regulatory compliance is all stored.

Production Efficiency SIMATIC IT Unilab follows the trend to shift from analysis of finished products towards quality analysis during the pro-cess, supporting quality checks during the process as defined in the SOPs, giving immediate feedback to the plant on anal-ysis results. From the reception of raw material, through the different produc-tion steps up to the shipment, the quality and variability of products and processes are monitored and reported.

This optimizes decision-making and supports corrective action taking and drastically reduces scrap and rework.Throughout the production, the quality control laboratory may also be involved in environmental testing. This secures production hygiene and helps control impact on the environment.

Lab EfficiencySimatic IT Unilab offers an intuitive LIMS environment with the GUI (Graphical User Interface) allowing the lab manager to manage LIMS workflows, work load, lab personnel and their qualifications.

The implementation and configuration costs and efforts are drastically reduced by the object oriented laboratory model of SIMATIC IT Unilab and the included templates (sample types, parameters, methods, …) which match a large portion of any lab’s configuration requirements, enabling appropriately authorized lab people to do the configuration themselves. These changes are systematically recorded for audit trail purposes.

SIMATIC IT Unilab provides time based or event based sample planning and automatically generates worklists per analyst. Significant time savings are the direct result of the instrument connections to the LIMS to speed up data entry and eliminate manual data entry errors, as well as the automatic reporting functionality with pre-defined reports and automated generation and distribution of approval reports and certificates of analysis.

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Siemens AG Industry Sector Industry Automation

The information provided in this brochure contains merely general descriptions or characteristics of performance which in case of actual use do not always apply as described or which may change as a result of further development of the products. An obligation to provide the respective characteristics shall only exist if expressly agreed in the terms of contract.

All product designations may be trademarks or product names of Siemens AG or supplier companies whose use by third parties for their own purposes could violate the rights of the owners.

Subject to change without prior notice nted in Germany © Siemens AG

Get more information www.siemens.com/mesmarketing.simatic-it@siemens.com

SIMATIC IT UnilabIntegrated quality management

SIMATIC IT Unilab is a solid and mature Quality Management System. It is fully integrated with ERP, MES, PLM and lab

equipment, bridging the gap between lab and production.

SIMATIC IT Unilab is applicable from single-site implementations with a few users to multi-site, multi-language licenses

for companies with thousands of users.

SIMATIC IT Unilab coordinates quality activities at HQ level with those of multiple plants and R&D Labs, and enforces the

use of common QA/QC methods and procedures.

SIMATIC IT Unilab generates time and cost savings:

• Improves lab efficiency• Reduces administration, errors, scrap and rework• Better decision support and management by exception• Reduces cost of regulatory compliance• Enforces corporate QA/QC procedures• Supports easy and fast roll-out to other plants

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