iStudyReporter QbD is a result of a joint development of CAMO and up to data and integrates the product UNSCRAMBLER X and iStudyReporter to one groundbreaking new product.
Multivariate Data Analysis on heterogeneous Lab IT
Multivariate Data Analysis provides innovative strategies for an efficient and overall data analysis that identifies patterns and relationships in complex data sets which traditional statistical analysis cannot.
Designed for special requirements of R&D and production within life science organizations, iStudyReporter ensures simultaneous real-time access to any LIMS, CDS, ERP and MES system. This builds a foundation for a consistent view on regulatory relevant information and for further multivariate data analysis. Unscrambler X seemlessly integrated with iStudyReporter will enable the analysis of process parameters and quality attributes based on real-time data from various systems, avoiding common inflexible procedures like the introduction of a complex data warehouse solution.
Quality by Design
The comprehensive exposure of data from research and development, clinical as well as enterprise manufacturing systems guarantees an adequate implementation of Quality-by-Design.
This superordinate view of process parameters and quality attributes from the holistic pharmaceutical product life cycle enables decision makers to come to informed decisions, in time and based on intelligence from all relevant business-units.
iStudyReporter QbD is more than flexible and requires only little IT infrastructure. The integration of up to data´s proven Remote Collector Technology ensures that interfacing with various laboratory data systems is convertible in no time at all. Thus makes it more affordable, easier to set up, simpler to run and to maintain, compared to conventional “process intelligence” platforms.
«iStudyReporter QbD» will be launched in Q4 2012 and will be the only solution on the market which enables the analysis of process parameters and quality attributes based on real-time data from a wide range of disparate systems.Press Release CAMO