Getting Data Smart
The pharmaceutical industry’s data deluge demands smarter management—rethinking regulatory frameworks, validation, and security to reduce redundant logs and storage while ensuring integrity, compliance, and efficiency in an increasingly digital ecosystem.
What do you see in the image above?
One has volumes of paper which has a printed code. The other has volumes of data which has been stored ~ about 5 petabytes of data, which is a lot. Half a ton of hard drives.
We all believe that we need this data and the current scientific situation is such that we would need this data. But then we believed that we needed those papers 50 years ago.
We in the industry specially pharmaceuticals, produce a lot of data, tons and millions of it, and the regulatory bodies ‘seemingly’ need this data to establish that systems and processes are reliable, have behaved the way they should and there is evidence to it. This data needs to be saved and preserved for a decade in some cases.
The data which needs to be captured or saved is Raw Data, Process Data, Batch Data, Validation Data and Training Data, QA, and QC Check Data and what now. With the industry moving to automation and going paperless, is it really a smart move? IMHO we are producing more data it is only that we are not printing it all the time so it is…
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