Information Technology

<p><strong><img src="https://kradminasset.s3.ap-south-1.amazonaws.com/ExpertViews/Sachin+bhandari.png" width="741" height="310" /></strong></p><p>&nbsp;</p><p><strong>What do you see in the image above?</strong></p><p>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.</p><p>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.</p><p>We in the industry specially pharmaceuticals, produce a lot of data, tons and millions of it, and the regulatory bodies &lsquo;seemingly&rsquo; 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.</p><p>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 not visible. It is stored in compact hard drives and tapes.</p><p>It is time that we start getting smarter on the data we produce and store. We need to find ways where the systems are so reliable once the sanctity is established (System Validated) and security controls proved, we get rid of</p><ol><li>Audit trails</li><li>Access logs</li><li>Process logs</li><li>Change logs</li><li>Historical data</li></ol><p>This data is huge and not only increases the cost and time consumed but requires significant energies to keep it in shape.</p><p>The current regulatory framework is such that we need the raw data and processed data to comply and then audit logs, access logs to support that your system and processes were not tampered with.</p><p>But then why can we redesign the validation and security framework/processes to make sure the system works as intended, can not be tampered with, and is secured all the time.</p><p><strong>It&rsquo;s time to wear our thinking hats and do some out of box thinking to be Data Smart.&nbsp;</strong></p><p>&nbsp;</p>