How document digitization has catalyzed the process of vaccine development?

As the world waited anxiously for an effective vaccine against Covid-19, the players in the pharma and life sciences sector navigate fresh challenges through digitalization and technology. Document management, which has always been critical for intensive preclinical, clinical and marketing phases of drug approval, became an increasingly cumbersome task in the wake of the pandemic. As the vaccine developers met with drug shortages, approval processes and supply chain challenges, the key to maintaining operations revolved around digital transformation and document management.

The conventional process of developing a vaccine entails rigorous paper-based processes, which is extremely time-consuming as well as expensive. To understand the traditional methods in simple terms, each document needs to be printed, signed, scanned and then faxed or mailed. This becomes even more cumbersome when signatures are to be obtained from different witnesses. It is only after their attestation that the documents are stored as proof of discovery and patent defence for a drug.

Some of the leading vaccine manufacturers soon realized the need of the hour and resorted to digital documentation tools to streamlining their documentation for a wide range of processes, including quality assurance and control, drug discovery, clinical trials, risk assessment, packaging of medicines, facilitating data collection of participants and reports generation of Covid positive cases.

For instance, one of the worlds’ leading vaccine manufacturers integrated Chemistry Electronic Notebooks, which converted the whole modus operandi into a streamlined digital signing process, giving chemists ample time for their experimentation. After the completion of an experiment, the chemist could directly enter the data pertaining to the experiment into CeN with their digital signature, following which a request for signature was sent automatically to the witnesses. The process was non-intrusive and traceable, leading to greater compliance with internal policies.

Arjit Bhargava, VP - Global Business Development, MSB Docs

In the course of vaccine development, a few outsourced development services, such as Contract Research Organisations, are also roped in by the players in the biotechnology and medical device industries. In their bid to accelerate drug development, they also relied on smart document solutions. For instance, one of our CRA application converted mobile devices into portable scanners. Once the application was from our security enterprise-level portals, the whole process became confined to one 5-step process. The document thus prepared finally ended up with the operations team and properly indexed to the final operation. The process that usually took 13 minutes now took only 3 minutes for completion.

Through digital documentation and eSignatures, the vaccine developers acquired a legally defensible signature trail. Adding to the accuracy parameters was the automated date-time stamp, eventually solving the problems around patent defence and intellectual property rights as well.

Responsive data management to deal with workforce and supply chain was another significant outcome of vaccine developers relying on digital documentation. Going digital optimized the facility operations through improved information or document management and control enabled the companies to ramp up and diversify production as the tide turned.

Apart from the benefits in the development stage, the pros of digital route for distribution and administration of vaccine is also plenty. Recently, the World Bank lauded the Indian government for repurposing digital platforms used in ongoing vaccination drive. The government has put in place mechanisms to digitally track the movement of vaccine stocks and trace the beneficiaries who would be administered the shots. Therefore, there is little doubt in stating that document digitization and technology, on the whole, has definitely catalyzed the process of vaccine development and distribution.

Author: Arjit Bhargava, VP - Global Business Development, MSB Docs