Given the rules-based nature of advanced information systems, regulatory compliance is built into laboratory software logic
, freeing technicians to read slides and interpret results without worrying about compliance issues or monitoring rescreens; the software does that for them.
We also have observed that over the lifetime of a body of software, each full-time software research and development (R&D) employee typically accounts for about 50,000 source lines of software logic
. In this accounting, R&D employees include developers, architects, testers, documenters and technical managers.
A more intelligent and workable way to be compliant with FDA 21 CFR Part 11 is to design a database level tool that intercepts transactions between the storehouse of data tables, which you might picture as a Rubik's cube type structure, and the software logic
for significant processes, and puts it into its own secure but organized database.
Anglesey County Council, in partnership with software designer Software Logic
, has developed an on-line journey planner to help people plan their journeys.
Whatever approach a company has taken to reach the point of an EBS implementation, it must understand that, to a greater or lesser degree, it is going to be adjusting its processes to fit the functionality embedded in the software logic
. "Most organizations thinking rationally will adjust their business processes to the ERP software," says DeWitt.
Each update increased the potential for a software logic