up to data and CAMO Software partner to deliver industry-first solution for Quality by Design initiatives in the Life Science industry
CAMO Software & up to data have partnered…
CAMO Software, leaders in multivariate data analysis software, and up to data professional services GmbH, a leader in regulatory study reporting software solutions, have partnered to deliver an industry-first solution for Quality by Design initiatives in the life science industry.
CAMO´s Unscrambler® X multivariate data analysis software will be seamlessly integrated with up to data’s iStudyReporter solution for regulatory compliant submission documents, creating the groundbreaking product «iStudyReporter QbD».
«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.
The comprehensive analysis of data from research and development, clinical and enterprise manufacturing systems allows organizations to more easily implement and realize the value of Quality by Design.
Designed specifically for life science organizations, iStudyReporter enables simultaneous real-time access to any LIMS, CDS, ERP and MES system. The data captured can then be analyzed with powerful Unscrambler® X multivariate methods, which identify patterns and relationships in complex data sets that traditional statistical analysis cannot.
This holistic view of process parameters and quality attributes from the complete pharmaceutical product lifecycle enables more timely and informed decision-making based on intelligence from all relevant business units.
In addition to detailed report processing capabilities, «iStudyReporter QbD» offers greater flexibility with minimal IT infrastructure required, avoiding common inflexible procedures such as the introduction of a complex data warehouse solution. This makes «iStudyReporter QbD» more affordable and easier to set up, run and maintain compared to conventional process intelligence platforms.
Norbert Bittner, Managing Director of up to data, says, “Many companies are reluctant to implement QbD because they assume it will be a very complex process with a poor cost/benefit ratio. With the introduction of «iStudyReporter QbD», we make QbD work on a practical level. It is designed to be easy to implement and run, based on our many years of experience in the life science industry.”
Brad Swarbrick, Vice President of Business and Product Development at CAMO Software, adds, ”The life sciences industry has an enormous wealth of data available, but too often insights that could be valuable in the product lifecycle are kept within one business unit. As a result, business critical decisions are often made on limited information. Our groundbreaking solution can help companies to get a competitive advantage through Quality by Design.”
The Unscrambler® X software offers advanced multivariate methods, data visualization tools and the ability to cut through large data sets. It is used in the pharmaceutical, food & beverage, chemical, energy, mining & metals, paper & agriculture sectors.
For more information on The Unscrambler® X suite of products please visit www.camo.com