Sm@rtLine Data Cockpit is a unique software middleware which enables the use of sensors and analyzers for the collection, review and approval of trial results. SDC is available in the versions SDC LS for use in laboratories and SDC IS as a black-box for the automatic transfer of data with master systems.
SDC is a middleware between LIMS, MES and DCS systems and the laboratory areas "research", "development" and "production".
SDC provides a central master data management of devices, samplings, samples and users.
SDC gives you the ability to compare measurements from research, development and production (e.g. interface calibration data) comprehensively.
SDC is a web- and database centered server platform that can be used from every client without special installation.
SDC includes management of user rights which guarantees safe access to data.
SDC is capable of controlling analyzers remotely so that the operator is using one consistent GUI when performing his tasks.
The operator can create, start and evaluate the analyzer measurements in a central system. The approved results can be uploaded to a foreign system (e.g. LIMS, MES or ERP).
SDC offers the functionality of generating measurement results based on the data retrieved from the analyzers. Available calculation methods include averaging and trypsinization.
SDC gives you the ability to combine a multitude of analyzers and sensors to form one system and to evaluate and compare the results.
SDC is a middleware which is placed between the sensors and the analyzers for the BIO-API processes and the interface to ERP (enterprise ressource planning), LIMS (laboratory information system), MES (manufactoring execution system) and DCS (distributed control system) systems. SDC provides standardized, flexible interfaces for these systems which deliver calculated and evaluated data.
The technican is no longer required to manually start and read measurements from the devices, but rather, the measurements for these devices are reported centrally on the SDC server. SDC allows you to measure faster and more frequently and save the evaluated data in a central system. From this data, you can form golden batch and compare your measurement and calibration curves together with multiple analyzers in a graph.
SDC supports your implementation of PATH / QbD (Process Analytical Technology / Quality by Design). These concepts strive to ensure a predefined product quality by implementing measures to improve understanding of the manufacturing process by using real-time measuring for all attributes. SDC supports these requirements by providing data transparency, reliability and traceability instead of manual measurement, where accuracy of data and precisely timed sampling cannot be guaranteed.
SDC incorporates validated interfaces which have been approved by Roche. This reduces your costs for validation and integration of the analyzers as well as reducing costs for the validation of the data handling. Overall, your costs are optimized through the improved data quality, your reaction time improves, production is streamlined and yield can be increased.
Reliability of data
SDC shortens measurement times, which leads to more frequent data and therefore to more knowledge about correllations between critical parameters. Reproducable and automated cell culture analysis improves the reliability of data.
The central database provides a unique point of information. Data-analysis occurs within ONE database and not in many different databases. Efficient data-evaluation occurs in One system for flexible data-analysis and reporting.
Global data collection increases the visibility of different processes. Global task sharing is facilitated.
SDC delivers the data simply and transparently. The operator saves valuable time on the preparation of measurements and data transfer.
Transparency and traceability
SDC makes a comprehensive correlation of analyzer and sensor measurements in research, development and production possible and creates transparancy and traceability.
Calibration data during a product lifecycle (research, development and production) can be compared and contrasted regardless of the device used.
Measurements can be repeated easily and they can be prepared while the analyzers are still working. It is possible to monitor measurement progress from anywhere within the company‘s network, including status observation of devices and calculation of time remaining. The measuring procedures of the analyzers are controlled without further user action.
Data evaluation / calculation
Individual measurement results of the analyzers and sensors can be evaluated and calculated into a single result (e.g., mean value, trypsinization). Measurement results can be evaluated / calculated according to batch ID and then displayed graphically in a "time cultivation chart". The integrated batch comparison enables comparison with the golden batch.
SDC's modern and intuitive operating concept is grounded in practical experience, resulting in wide acceptance and minimizing need for on-the-job training.
SDC reduces the validation efforts tremendously by replacing the manual transaction and processing of data by the user.
GMP conforming data handling
Paperless data handling of measurements and data transfer to foreign systems (LIMS, MES, ERP) occurs with electronic signatures and change logs in consideration of 21 CFR Part 11. This ensures the data integrity of all measurements and further parameters. The operator can transfer data for special reports or evaluations easily to Excel.
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. Due to modern web technology, no additional installation work is necessary at the client site.
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 a continual expansion of the system.
User administration (user- and rights-management) can be linked to the active directory.
SDC supports the central data backup of results and images.
A setup oriented toward master data enables conformity and expandability.
SDC is a fully developed .NET technology with an Ajax GUI framework and MVP architecture.
Real-time data leads to more accurate process adjustment. Real-time monitoring increases process understanding.
Ready for automation
SDC creates the basis for future automated processes. The development data can be compared to the production data and all process information (sensors and analyzers) can be viewed on a common timeline. The golden batch can be formed through real-time monitoring for "Closing the Loop" (QbD = Quality by Design).
Boost of quality and yield
More effective and faster processing time of trials makes more frequent measuring possible, optimizes process monitoring and boosts both quality and yield.
With SDC, the user can consolidate all sensors and analyzers used in fermentation research, development and production into a single system. This method makes the work easier and safer.