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Cloud technologies to bolster Indian life science companies to widen data integrity across value chain

Nandita Vijay, Bengaluru
Saturday, December 18, 2021, 08:00 Hrs  [IST]

Cloud technologies can strengthen Indian life science companies with the ability to extend data integrity across the value chain. While at the same time it can enable the partnering companies to access information they need to provide valuable services. Therefore, Cloud technologies for Indian life sciences companies is a game changer to drive operational efficiencies and enhance compliance.

According to Varadarajan Srinivasan, general manager, Veeva Systems, for life science companies there is a need to have control over their data generated both internally and externally.  

Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical production functions are outsourced, thus limiting the amount of oversight that happens in pharmaceutical companies.

Quoting global regulators like the US FDA, he pointed out that data not being valid and trustworthy is a sign for an entire operation or a facility to be out of control and cannot assure the quality of the medicines manufactured.  Even the ICH Q10 stated a pharmaceutical company is ultimately responsible to ensure that the required processes are in place to assure the control of outsourced operations and quality of purchased materials. Further, the US FDA also holds the owner’s quality unit ultimately responsible for approving and rejecting drug product manufactured by the contract manufacturer.

Therefore without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products, added Srinivasan.

On a similar note, Snehal Srikrishna, senior director, strategy, manufacturing and quality, Veeva Systems observed, that quality processes continue to span across pharma companies and contract manufacturers, where many supporting systems were designed to operate only within a company’s four walls. Many of these applications do not work well together and often exist in silos resulting in significant operational inefficiencies.

It is here using cloud-based technology from Veeva Systems helps to streamline drug development and manufacturing as it integrates both internal stakeholders and external partners into the process end-to-end. Every activity that generates data is controlled and can be supervised. This reduces the risk of data being manipulated or lost amidst fragmented processes and disparate systems,” said Srinivasan.

Raw material suppliers, CROs (clinical research organisations), CMO (contract manufacturing organisations) and distributors can interact simultaneously under controlled conditions to ensure that accurate, up-to-date information is always available to those that need it whenever, wherever, or however.

“The industry must stop looking within, and start looking for solutions elsewhere. Our offering manages quality content and processes bringing together all stakeholders on one platform and ensure an auditable trail of all activities with partners. Ultimately, the cloud offers an efficient and effective way to externalize manufacturing and maintain internal control of quality. Hence, cloud technologies bolster Indian life science companies to widen data integrity across the value chain,” stated Srinivasan.

 

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