Bayer Business Services BayCovin Service Manual

BayCovin

TM

Instruments

Logistics Solutions

Bayer Business Services GmbH - Customer & Sales Service Center

51368 Leverkusen

Phone: [phone]

E-Mail: [e-mail]

Internet: www.BayerBBS.com

Product information

Current laboratory automation is typically characterized by a
variety of different instruments from different vendors, a large
number of different analytical methods and the usage of dif­ferent information systems. To facilitate a continuous flow of
information, these information systems require an online inter­face to the analytical instruments. BayCovinTMInstruments
bridges the gap between the quality management (QM) func­tionality of mySAP Product Lifecycle Management (PLM) and
the instrumentation at the laboratory level. BayCovinTMInstru­ments is lean middleware, especially designed to provide a
smooth flow of information from analytical instruments to SAP

®

R/3. Extending the workflow to the analytical devices augments
the potential of the QM functionality of mySAP™PLM as a fully­fledged laboratory information and management system (LIMS).

Using a SAP-certified interface to QM-IDI, inspection lots cre­ated in mySAP™PLM QM are downloaded asynchronously to
the Oracle™-based BayCovinTMInstruments Server. This down­load does not require a permanent online connection, thereby
improving system availability and performance of the labora­tory IT environment.

Downloaded characteristics (final results) are enriched by cha­racteristics specific for the analytical method. The BayCovin

TM

Instruments server provides the BayCovinTMInstruments client
with a work list of inspections that depend on analytical method
and instrumentation requirements. The client controls the labo­ratory devices and collects raw quality inspection data from
the instruments. Additionally, the client offers manual result
entry for inspection characteristics and meta data. After data
acquisition the BayCovinTMdatabase triggers automatic cal­culations of partial or final results. If required by quality
management regulations such as GLP/GMP or FDA 21 CFR
Part 11 electronic signatures can be used, for example, pass­words or bio-metrics. BayCovinTMInstruments actions are
monitored by a configurable audit trail. 4-eye principle for result
entry and validation of results for SAP can be enforced. After
validation, which is optional, the measured and calculated end
results are sent back to mySAP™PLM QM to trigger subse­quent actions in the logistic chain. The data is managed and
archived in compliance with FDA regulations (21 CFR Part 11)
and ISO quality standards.

Operational use & Perspectives

BayCovinTMInstruments is designed with the regulated envi­ronment in mind. Our measures for product quality are in com­pliance with the current GxP regulations. The increasing requi­rements of our customers are the major focus of our product
release strategy and our support organization.

Benefit

★ Efficient – Manual-free result entry, automatic data acqui-

sition, support of formula calculations, authentication and
electronic signatures by biometrics, workflow control and
result entry by barcode reader.

★ Lean – Add-on for quality management in mySAP™PLM;

small implementation projects and reduction of support
costs.

★ Validated - BayCovinTMInstruments software life cycle is

compliant with current ISO & GxP regulations and with FDA’s
21 CFR Part 11 for electronic signatures, configurable
authentication and configurable workflow for result valida­tion, support of regulated and non-regulated environments.

BBS – your partner

Bayer Business Services is a service company of the Bayer
AG. It offers integrated consulting and implementation pro­ducts, supporting customers with innovative services for their
business processes. The goal is to make a sustainable contri­bution to the value creation of the customers.

System requirements

SAP®R/3 (Version 4.6.B or higher)
Oracle®Server (Version 9.2.0 or higher), Oracle®Client (Ver­sion 8.0.6 or higher)

Contact

Dr. Matthias Dräger

Bayer Business Services GmbH
Logistics Solutions
Phone: [phone]
E-Mail: [e-mail]

Supply Chain Management and Laboratory Automation.

BayCovinTMInstruments - 02.2004

Remarks:

★ BayCovin™ is a trade mark of Bayer Business Services GmbH.
★ The product names SAP

®

‚ SAP®R/3, SAP®R/3 QM, mySAP™ PLM, Oracle®Server and Oracle®Client are trade marks of our suppliers. They are only used for the pur-

pose of a COVIN product description.