A Novel Approach to Pharmaceutical Registration ‐ Registration as a Service

September 2011 Author: ()

GSK has, over the last several year, taken an aggressive look at cost control in the IT area. Many IT systems and processes have been revamped in an effort to reduce cost. One of those efforts targeted our chemistry cartridge implementation and associated systems. The cartridge that was the prior GSK standard required a large maintenance spend and the technology was not moving forward. After performing a market evaluation GSK made the move to JChem. In making this choice, the GSK Registration system was also targeted for replacement since the application was based on the previous technology.

Not only was the registration system to be replaced, but the process needed re-engineering itself. Cuts in staffing reduced the number of registrar significantly from 5 FTEs to 2 FTEs. With the previous system, the registrars were the Quality Assurance administrators of the registry data. They ensured that standards were met for all aspects of registry representations. The teams challenge was to develop and implement a JChem based registration system in conjunction with ChemAxon, that would allow the quality of the registered data to be maintained while reducing the registrar support needed to curate. Some of this “QA” burden needed to be pushed back to the chemists synthesizing the compounds.

The GSK teams second challenge was to select an implementation that would “fit” with the reductions in support staff that came with GSKs cost cutting measures. In order to address this issue, GSK and ChemAxon have designed a novel approach to Software as a Service that allows protection of GSKs IP investment, but still lets the software management and support be “owned” by ChemAxon. This presentation will summarize our progress, some of the issues that we have encountered and plans for the system in the future.

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