LABELMANAGEMENT WITH SAP - INTEGRATION

Transcription

1 LABELMANAGEMENT WITH SAP - INTEGRATION Vetter Pharma-Fertigung GmbH & Co. KG LABELING SOLUTIONS FOR PROFESSIONALS SAP Labelmanagement from OPAL and BarTender label software from Seagull Scientific ensure flawless processes at Vetter, a leading provider of pharmaceutical services.

2 cartridges is crucial to patient safety. Since 2012, Vetter Pharma has used SAP -integrated Labelmanagement Printing Solution software, which includes Seagull Scientific's BarTender software, from AutoID specialists OPAL. The result: Top-quality, Top-quality, compliant compliant labeling labeling processes processes. with Our the Labelmanagement new system has realized solution an from enormous OPAL. increase in quality. The OPAL and BarTender solution ensures correct GMP version creation for automated label printing processes, with a transparent audit trail captured along the entire processing chain. We plan further integration in these processes as part of our ongoing serialization projects, said Vetter s manager responsible for SAP key Company Vetter Pharma-Fertigung GmbH & Co. KG Founded in 1950 Employees: (Europa and USA) At a glance Sector Pharmaceutical Challenges Integration of Labelmanagement-software in SAP Conversion of 500 existing label layouts GMP-compliant data content for labeling and version creation Flexible printer incorporation Integration of different numbering and serialization systems Vetter Pharma-Fertigung Integration GmbH & with Co. Vetter`s KG is a leading bespoke global SAP pharmaceutical printing program service provider for clinical development and commercial production of parenteral medications. The company specializes in the aseptic filling of syringes, cartridges Benefits and vials. Vetter manages the entire product life cycle in its processes, supplying pharmaceutical and bio-technology companies throughout the global market with services including pre-clinical development and regulatory User-friendly approval. operation Overall, the company employs about 3,300 people in Europe and the USA. Annual production of approximately Stable, easy-to-use 180 application million units in makes SAP Vetter the global market leader in the pre-filled injection system sector. Flexible labeling processes and printer incorporation Quality improvements through automatic sourcing of variable data Scalable solution Incorporation of serialization

3 GMP-compliant label printing at Vetter, a leading global provider of pharmaceutical services Accurate, cartridges traceable is crucial labeling to patient during safety. the clinical Since 2012, development, Vetter Pharma manufacturing has used and SAP packaging -integrated of syringes Labelmanagement and cartridges software, is which crucial includes to patient Seagull safety. Scientific's Since 2012, BarTender Vetter Pharma software, has from used AutoID SAP -integrated specialists OPAL. Labelmanagement software, The result: which Top-quality, includes Seagull compliant Scientific's labeling processes. BarTender Our software, new system from AutoID has realized specialists an enormous OPAL. increase in The quality. result: The Top-quality, OPAL and compliant BarTender labeling solution processes. ensures Our correct new GMP system version has creation realized for an automated enormous label increase printing quality. processes, The OPAL with a and transparent BarTender audit solution trail captured ensures along correct the GMP entire version processing creation chain. for automated We plan further label printing integration in processes, these processes with a transparent as part of our audit ongoing trail captured serialization along projects, the entire said processing Vetter s chain. manager We responsible plan further for integration SAP key in these user processes production. as part of our ongoing serialization projects, said Vetter s manager responsible for SAP key Case Study Vetter Pharma-Fertigung GmbH & Co. KG is a leading global pharmaceutical service provider for clinical Vetter development Pharma-Fertigung and commercial GmbH & production Co. KG is of a parenteral leading global medications. pharmaceutical The company service specializes provider for in clinical the aseptic filling development of syringes, and cartridges commercial and vials. production Vetter of manages parenteral the medications. entire product The life company cycle in its specializes processes, in supplying the aseptic filling of pharmaceutical syringes, cartridges and bio-technology and vials. Vetter companies manages throughout the entire product the global life market cycle in with its processes, services including supplying pre-clinical pharmaceutical development and and regulatory bio-technology approval. companies Overall, throughout the company the global employs market about with 3,300 services people including Europe pre-clinical and the USA. development Annual production and regulatory of approximately approval. 180 Overall, million the units company makes employs Vetter about the global 3,300 market people leader in Europe in the and pre-filled the USA. Annual injection production system of sector. approximately 180 million units makes Vetter the global market leader in the pre-filled injection system sector.

4 About 2,000 cartons packed with injection products leave the facility in Ravensburg every day. Every carton is given its own shipping label, which adds up to about 450,000 shipping labels produced annually. We are cartridges is crucial to patient safety. Since 2012, Vetter Pharma has used SAP -integrated Labelmanagement contract manufacturers, which means that we do not provide medication directly to the market ourselves, but software, which includes Seagull Scientific's BarTender software, from AutoID specialists OPAL. simply deliver the finished products to our customers, the pharmaceutical companies. Our customers determine The result: Top-quality, compliant labeling processes. Our new system has realized an enormous increase in how the labels are created each customer needs specific information on the label for its own subsequent quality. The OPAL and BarTender solution ensures correct GMP version creation for automated label printing processing work, said Vetter s SAP key user production manager. The labels produced by Vetter must processes, with a transparent audit trail captured along the entire processing chain. We plan further integration in accommodate different layouts, logos and fonts. 1D Barcodes and Data Matrix codes contain a range of variable these processes as part of our ongoing serialization projects, said Vetter s manager responsible for SAP key details, including batch number, expiration date, customer material numbers and regulation-mandated serialization schemes. Vetter Pharma-Fertigung GmbH & Co. KG is a leading global pharmaceutical service provider for clinical Creating label layouts using BarTender from Seagull Scientific development and commercial production of parenteral medications. The company specializes in the aseptic filling of syringes, cartridges The company and vials. has Vetter been manages using BarTender the entire product label design life cycle software in its to processes, create its supplying label layouts since The pharmaceutical and BarTender bio-technology Enterprise companies Automation throughout edition the includes global market powerful with functions services for including managing pre-clinical Vetter s required label design development and standards regulatory and approval. for easy Overall, integration the company with Vetter s employs existing about SAP 3,300 technology people in infrastructure. Europe and the This USA. enterprise-level Annual production software approximately tool enables 180 us million to quickly units print makes perfect Vetter barcode the global labels. market It is extremely leader in the user-friendly pre-filled to work with, and for injection system sector. newcomers it is also easy to learn. The software's flexibility is also very popular at Vetter: BarTender supports all Windows fonts and printers, with system-wide support for Unicode.

5 Integrating labeling process with SAP Vetter s cartridges continuous is crucial quality to patient improvement safety. Since strategy 2012, led Vetter the company Pharma to has seek used a new SAP labeling -integrated solution Labelmanagement that would enable software, the company s which includes existing Seagull SAP Scientific's system to BarTender print BarTender software, labels. from We d AutoID had specialists an excellent OPAL. experience with BarTender The result: label Top-quality, design software, compliant and labeling we wanted processes. to import Our new our label system formats has realized from our an existing enormous stand-alone increase in implementation quality. The OPAL of BarTender and BarTender, said solution the manager ensures of correct Vetter s GMP IT applications version creation division. for automated Vetter also required label printing version creation, processes, secure with access a transparent to the label audit formats trail captured and direct along control the entire of the processing printers, and chain. complete We plan GMP further labeling integration standard in compliance. these processes as part of our ongoing serialization projects, said Vetter s manager responsible for SAP key AutoID-specialist with SAP -expertise After researching available labeling technologies, Vetter chose to implement the OPAL SAP -integrated Labelmanagement Vetter Pharma-Fertigung system. GmbH OPAL s & extensive Co. KG is experience a leading global in over pharmaceutical 500 large, complex service SAP provider BarTender for clinical labeling system development integrations, and commercial factored in the production decision. of parenteral medications. The company specializes in the aseptic filling of syringes, cartridges and vials. Vetter manages the entire product life cycle in its processes, supplying pharmaceutical and bio-technology companies throughout the global market with services including pre-clinical development and regulatory approval. Overall, the company employs about 3,300 people in Europe and the USA. Annual production of approximately 180 million units makes Vetter the global market leader in the pre-filled injection system sector.

6 Installation of a 3-system environment cartridges is crucial OPAL to patient installed safety. a three-system Since 2012, environment Vetter Pharma (development, has used SAP testing -integrated and production) Labelmanagement according to Vetter s software, which includes requirements, Seagull enabling Scientific's the BarTender creation, printing software, and from administration AutoID specialists of the labels OPAL. directly via the SAP system many The result: Top-quality, parameters compliant are available labeling processes. as standard Our options new in system the OPAL has realized Labelmanagement an enormous software. increase Label in formats, label printers quality. The OPAL and location BarTender specifications solution ensures are administered correct GMP directly version through creation the for OPAL automated SAP -integrated label printing system. processes, with a transparent audit trail captured along the entire processing chain. We plan further integration in According to Vetter, label formats can be set up quickly, with no software development skills required. The these processes as part of our ongoing serialization projects, said Vetter s manager responsible for SAP key Labelmanagement system is user-friendly and was easy-to-use right from the start. The Vetter team is also pleased with the built-in security throughout the label creation process. Every layout modification is logged by the OPAL software, as required by GMP. Any hardware malfunction generates an immediate notification, so the system operator can intervene right away. OPAL supported us not only in the system s implementation, but also with its validation documentation, and troubleshooting. We re very satisfied with the services we received, and with the training provided to our employees. Conversion and Go-Live The complete system conversion took place over the course of six months. Label formats were configured during this phase, facilitating a smooth transition to the new, integrated data sourcing process. Upgraded software was installed. The new system went live during the second quarter of Transparent label printing process Vetter Pharma-Fertigung GmbH & Co. KG is a leading global pharmaceutical service provider for clinical development and Today, commercial Vetter production packs, palletizes of parenteral and prepares medications. units for The shipment company using specializes its state-of-the-art in the aseptic packaging filling lines. Customized of syringes, cartridges label and layouts vials. are Vetter saved manages for every the item. entire An product electronic life catalog cycle in of its the processes, label class supplying data required for each customer and pharmaceutical and product bio-technology was assembled, companies and throughout enables functions the global like market conditional with printing services or including other languages pre-clinical to be automatically development and integrated regulatory in approval. the label Overall, design the process. company Specific employs information, about 3,300 such as people the customer in Europe material and the number, USA. order and batch Annual production numbers, of approximately is pulled 180 directly million from units SAP makes with each Vetter order. the global market leader in the pre-filled injection system sector.

7 Label printing using industrial printers Approximately cartridges is crucial 30 industrial to patient label safety. printers Since from 2012, several Vetter different Pharma manufacturers has used SAP are used -integrated the Vetter Labelmanagement facilities. Printing software, commands which includes are initiated Seagull in SAP Scientific's, providing BarTender data recording software, and from printing AutoID of specialists the batch protocol. OPAL. Direct control of The labeling result: can Top-quality, also be set compliant up using labeling the new processes. system: Since Our a new new system label does has realized not have an to enormous be created increase for every in print quality. job, we The can OPAL now and load BarTender the correct solution label media ensures in the correct printer GMP in version advance, creation and with for the automated click of a label button printing select the processes, right label with to print. a transparent audit trail captured along the entire processing chain. We plan further integration in these processes as part of our ongoing serialization projects, said Vetter s manager responsible for SAP key Quality improvement thanks to automated data provision According to Vetter, the automated management of data within the labeling process has resulted in further quality improvements. Populating the variable data on the label directly from the database completely eliminates the need for manual input. This guarantees that we provide the correct data on the correct label. We now operate a complete SAP -integrated, automated Labelmanagement solution, said both of Vetter s IT experts. The system provides GMP-compliant versioning and a complete audit trail of label formats. Now we always know by whom, for what product and when a format was changed, and who initiated the blocking or the release. This enables us to meet all of our obligations for documenting the labeling processes. Case Case Study Study Expansion through serialization Serialization capabilities have been added, expanding the scope of the system for compliance with global pharmaceutical traceability regulations. Each product now is marked with an individual serial number, which is registered with the appropriate regulatory agencies, where necessary. Another advantage of the OPAL Vetter Pharma-Fertigung GmbH & Co. KG is a leading global pharmaceutical service provider for clinical Labelmanagement solution is that it makes this process scalable. development and commercial production of parenteral medications. The company specializes in the aseptic filling Vetter of syringes, is currently cartridges considering and vials. a change Vetter from manages batch-level the entire printed product stock life to printing cycle in the its processes, individual labels supplying on demand, when pharmaceutical the package and is created. bio-technology Every companies batch is currently throughout prepared the global using the market batch with protocol. services The including number pre-clinical of labels corresponds development with and the regulatory order quantity. approval. They Overall, can be the printed company as stock employs and affixed about manually. 3,300 people We are in Europe now considering and the USA. de-centralized Annual production printing, of approximately which means that 180 whenever million units a package makes is Vetter created, the global the printer market will leader print out in the pre-filled label. The label injection could system be printed sector. on-site at various locations once the package has been created and it has been registered in SAP.

8 Americas: EMEA: APAC: Japan: JapanSales@SeagullScientific.com Seagull Scientific, Inc. BarTender is a registered trademark of Seagull Scientific, Inc. All other trademarks are the property of their respective owners.