Sm@rtLine Data CockpitData Cockpit for Research, Development and Production

Sm@rtLine SDC

SDC

MODUL

The Data Cockpit for BIO-API

®

SDC

Sm@rtLine SDC

Sm@rtLine Data Cockpit [SDC] is a software program for the collection, review and approval of trial results (samples) from simple sensors to complex analyzers.

v SDC is a web- and database-based individual results of the readings can be platform that brings together the recalculated to illustrate the total result. analyzers and sensors for the BIO-API Available calculation methods include fermentation process. averaging and trypsinization. After electronic signature, it transmits approved results to higher systems such as LIMS, MES or ERP.

The analyzers' user interfaces will be replaced by SDC as much as possible, the advantage being that users obtain integrated and uniform guidance for different types of analyzers.

SDC furthers the functionality of (for example) Cedex™ analyzers in that

SDC gives you the ability to compare measurements from research, development and production and thereby compare the results (e.g. interface calibration data) transparently, optimizing the entire process.

Developed with special consideration given to GAMP 5 requirements, this qualified program is particularly well-suited for the pharmaceutical industry.

Einführung

SDC

Sm@rtLine SDC

Research Development Production

SDC gives you the ability to combine a multitude of analyzers and sensors in research, development and production to form one system and to evaluate and compare the results. You can connect master systems such as LIMS and MES systems as well as automation technology or other data sources.

Status monitoring of analyzers during measurements allows for the clear supervision of several systems at once.

Integrated display of time remaining for readings eases the planning of further measurements. The next free analyzer can be assigned to the next measurement.

CEDEXCEDEX HiRes™

CuBiAn™Cobas™

and others

™

SDC

RESULTS

MEASUREMENTS

Start measurements

LIMS communication

Create measurements

SENSORS

ANALYSERS

Etc.

Cubian

Cobas

CEDEX HiRes

CEDEX

Approval

Calculation

Transfer to LIMS

AREA

Research

Development

Production

LIMS, MES, ERP

PT100

Current/voltage

Distributed control system PCS7, 800xA, DeltaV

TM

TM

TM

TM

TM

Cedex, CedexHiRes, Cobas are trademarks of the company Roche, CuBiAn is a trademark of the company Furuno Electric Co.LTD

With SDC the user can consolidate all

sensors and analyzers used in

fermentation research, development and

production into a single system.

Calibration data during a product

lifecycle (research, development and

production) can be compared and

contrasted regardless of the device used.

Measurement results can be assessed

and approved before being sent

electronically to a LIMS or MES system.

Individual measurements for the

differing analyzers and sensors can be

assessed, cleared and incorporated into a

single result (mean value, trypsinization).

Easy repetition of measurements.

Measurements can be prepared while

analyzers are still working.

Monitoring of measurement progress

in the complete company network

including status observation of devices

and calculation of time remaining.

Control of the measuring procedures of

analyzers (e.g. Cedex™) without further

user action.

Correlation and synchronization of

analyzers and sensors with common

evaluation, graphing and storage.

Measurement results can be evaluated

according to batch ID and then displayed

graphically in a „Time cultivation chart“.

The integrated batch comparison enables

comparison with the Golden Batch.

Interfaces enable the export of data to

Excel.

AGU 2010 ©

SDC

AGU Planungsgesellschaftfür Automatisierungs-, Gebäude- und Umwelttechnik mbHVon-Ketteler-Straße 151371 Leverkusen

Telephone: +49 214-86 860-13 oder -11

E-Mail: oder

Internet: www.agu.de

bruch@agu.de voges@agu.de

The comprehensive correlation of

analyzer and sensor measurements in

research, development and production

creates transparency and traceability.

SDC's modern and intuitive service

concept is grounded in practical

experience, resulting in wide acceptance

and minimizing need for on-the-job

training.

SDC can be used as a remote solution

for facilities regardless of location. Due to

its integrated web technology, SDC can be

used within the complete network

centrally or remotely.

Paperless data handling of

measurements and data carryover onto

higher systems (LIMS, MES, SAP) occurs

with electronic signatures in

consideration of 21 CFR Part 11.

More effective and faster processing

time of trials makes more frequent

measuring possible, optimizes process

monitoring and boosts both quality and

yield.

Through electronic signatures and

change-logs, SDC ensures the data

integrity of all fermentation data and

supports GMP requirements according to

21 CFR Part 11.

Two available languages (D, E) make

SDC an effective tool whose practical

benefits manifest quickly.

No additional installation work at client

site due to modern web technology.

SDC has an open interface concept that

enables the connection of LIMS, MES and

ERP through XML, SQL and OPC.

The adapter concept for the connection

of analyzers and sensors allows for

continual extension of the system.

User administration can be linked to

Active Directory.

Central data backup of results, graphs

and images.

Setup oriented toward master data

enables conformation and expandability.

The use of either Oracle or MS SQL

databases is possible.

SDC distinguishes itself through fully

developed .NET technology with an Ajax

GUI framework and MVP architecture.

UsersUses / Advantages

ManagersUses / Advantages

ITUses / Advantages