Company plans to reduce cycle time in new product development by standardising on data management platform, which will be deployed at up to 15 sites worldwide
Waters reports that Apotex, the largest Canadian-owned pharmaceutical company, is implementing the Waters NuGenesis SDMS (scientific data management system) across its worldwide R and D operations in an effort to reduce the time it takes to develop new products and bring them to market.
"Based on our initial implementation of the Waters NuGenesis SDMS platform, we're confident that the Waters NuGenesis SDMS system will enable Apotex to significantly reduce the overall cycle time for the development and approval of new generic drugs", stated Michael Davidson, CIO at Apotex.
Initially, Apotex will roll out the NuGenesis SDMS across three continents and eventually deploy it at up to 15 sites worldwide, giving all its scientists access to the platform.
NuGenesis SDMS features that are expected to help Apotex with the streamlining process include electronic signatures, capture of all laboratory data including the ability to control and audit changes to documents generated from Microsoft Excel and Word and access to data generated at sites across the globe.
Also, when the NuGenesis SDMS is deployed in between 'data generators' like analytical instruments and a Lims, the SDMS acts as a single point of contact from which Lims can pull necessary data in order to perform custom calculations.
This strategy is expected to make it considerably easier for Apotex to move to a completely electronic laboratory data management process.
The relationship between Waters and Apotex dates back to 2001 when Apotex deployed the Waters NuGenesis SDMS within its regulatory affairs group to streamline the electronic submissions process.
Apotex has seen gains in efficiency primarily from the application-independent nature of the platform.
For example, regulatory affairs personnel have been able to access all scientific data without needing to learn how to use - and needing a license for their resident chromatography data system and 15-20 other scientific applications.
They can view all data, pick and choose which data to include in their submission, and then simply create the appropriate multi-dimensional report from the NuGenesis SDMS.
Managing data in the modern laboratory.
The typical process for the development of a new generic drug requires a large amount of data generated during the process control, formulation, stability, quality control and regulatory lot release processes.
The Waters NuGenesis SDMS platform automatically captures and catalogues all data - instrument and office applications - and aggregates the content into a single data repository.
This repository can be accessed, viewed and re-purposed by approved individuals for critical decision making during the research and development process.
"Waters is committed to the idea of helping companies like Apotex manage more of their scientific data - no matter where it is generated or in what format", said Rohit Khanna, vice president of marketing, Waters.
"With state-of-the art tools like the NuGenesis SDMS, Waters can help companies like Apotex cut new product time to market by bringing new levels of efficiency to the scientific lab."
