Manage, analyze, and report bioprocess development, validation and operational GMP data with the leading real-time bioprocess data analytics software inCyght®
inCyght® combines data management, data visualization & statistical analysis from all data sources in one intuitive software environment
inCyght® Key Features
Intelligent Data Visualization for all Unit Operations
inCyght® offers an intuitive visual analytics environment for the intelligent visualization of all process data types. The unique inMatrix visualization concept intelligently selects the right visualization scheme for your process data. This enables scientists and engineers to simultaneously plot data from all unit operations to detect trends and correlations.
Flexible Bioprocess Data Management for Laboratory and Manufacturing
inCyght® offers management of time series, sensor, quality and spectral data as well
as video- and image data. A broad spectrum of customizable database filters enables
you to quicky identify relevant batches, unit operations and data types required for your
analysis. Soft sensors enable you to extract maximum information from process data in your database. The out of the box data management functionalities are ideal for process development, process validation and quality trending / biosimilarity activities. inCyght® offers
fast integration of all process relevant data sources via real-time connection to laboratory
equipment and high throughput process development equipment, drag&drop browser
import for tabular data as well as server crawl functions. Content Packs
The Must-Have Analytics Tools for Statistical Analysis
Similarity analysis features enables user-friendly and statistically sound analysis of scale-ups, technology transfers and unit operations. Using multivariate and univariate statistical tools engineers quickly identify processing trends and correlations. In addition, statisticians can directly connect to the database using R and Python connectors for advanced and flexible statistical analysis. The out of the box statistical tools fullfill the requirements for process validation, technology transfer and quality trending/ biosimilarity statistical analysis. Content Packs
Strain Information Management & Analysis
inCyght® manages and visualizes strain geneologies. This enables scientists and engineers to freely explore genetic modifications performed on production strains in combination with strain performance and growth data. In addition, lab managers create the neccessary GMO documentation according to the local GMO legislation.
FDA 21 CFR Part 11 Compliance
Exputec inCyght® features Audit Trail, Access Protection, Copies of Records, Record Retention, Electronic Signatures and a Validation Roadmap to meet FDA 21 CFR Part 11 and
EudraLex Annex 11 requirements. For detailed information on the compliance package
please download our whitepaper.
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Exputec’s pre-configured content packages provide a jump-start for deploying Exputec inCyght® to solve process development and manufacturing challenges. They are based on the industry's best practices and the know-how of Exputec consultants and reflect the requirements of bioprocess development, operation, as well as validation scientists and engineers.
Bioprocess Design, Analysis & Control
Exputec inCyght® Bioprocess Analysis content packages offer pre-configured mass balancing workflows, data analysis workflows, soft-sensors and reporting templates to analyze and report bioprocess data. By using Exputec inCyght® Bioprocess Analysis content packages along with the associated comprehensive consulting services, inCyght® users extract maximum information from bioprocess data.
Content packs for following unit operations are available:
- Microbial fermentation
- Cell culture fermentation
- Preparative chromatography
Biopharmaceutical Process Validation
Exputec inCyght® Biopharmaceutical Process Validation content packages along with the associated comprehensive statistical consulting services, provide a software guided framework and statistical tools for solving bioprocess development and manufacturing challenges.
Content packages for the following tasks during the bioprocess lifecycle are available:
- Scale-down model qualification
- Design and execution of process characterization studies
- Analysis and reporting of technology transfers
Quality Trending & Biosimilarity
Exputec inCyght® Quality Trending & Biosimilarity content packages along with the associated comprehensive statistical consulting services, provide a software guided framework and software tools for advanced data management, trending and statistical analysis of quality data.
- Management of all quality relevant data types (a.o. Bioassay, HPLC, ELISA)
- Univariate and multivariate analysis of similarity and bioequivalence
- Quality trending dashboards using univariate- and multivariate control charts
|E-mail Helpdesk Support|
|Statistical Data Analytics|
|Feature-based Data Analytics|
|inCyght Plug-Ins: 1 Plug-In included|
|User Management Administration|
|Numerical Computing Environment|
|Dashboard Development kit|
|inCyght Server License (1 customer server)|
|inCyght SaaS Data Backup for 10.000 Batches|
For additional information and pricing please contact us.
|inCyght® Fermentation Expert - Installed on the desktop PCs of the users|
|Processor||Intel Core i5 or higher, 64-bit CPU required|
|Memory||4 GB (8 GB recommended)|
|Hard drive||2 GB free space during installation, 1 GB after install required|
|Operating System||Microsoft Windows 7 or later (64-bit required)|
|Browser||Mozilla Firefox, Google Chrome or Microsoft Edge / Internet Explorer (10+)|
|inCyght® Web - Installed on a server and access via Intranet|
|Server||Different envronments supported (e.g. Linux or Windows based, 64 bt required), Docker based installation|
|Memory||8 GB (depending on user number)|
|Hard drive||6 GB for installation of software (SSD recommended) + additional storage for data|
|Client||Operating system||Microsoft Windows 7 or later, Linux (64-bit required)|
|Browser||Mozilla Firefox, Google Chrome, Microsoft Edge / Internet Explorer (10+)|