Jumping into the Digital World

COVID-19 has accelerated digital adoption of new technologies moving pharmaceutical and life sciences companies away from paper-based processes and towards electronic data capture. Rightly or wrongly, many pharma companies have traditionally preferred paper-based systems for recording and sharing data, which has exposed inefficiencies. For example, one customer explained to me how, pre-COVID-19, their suppliers were adamant that they had to always supply a physical document. The document would need to be printed, physically signed, scanned, and then returned. Now, many employees are working remotely and not all have access to printers and scanners; as a result, companies have been forced to adopt new software and platforms that allow business to continue as normal.

In the pharmaceutical and life sciences industry, traveling to a supplier or partner site to perform an audit has also changed, with regulators and market authorization holders performing these critical assessments virtually. In line with recent EMA, FDA, and MHRA guidance, both parties involved in the virtual audit have had to put digital solutions in place. Gone are the days when you could take the auditors to a boardroom and present them with endless boxes of paper documents to prove compliance. Instead, companies have rolled out new software tools allowing them to share electronic documents, such as, SOPs, training materials, and quality documentation directly in a software platform, and seamlessly collaborate and communicate with all parties involved in the audit.

Although digitization is new to pharma, it is not new to other industries. Many companies elsewhere have embraced digital technology, and software companies have spent decades developing flexible and agile platforms. Operating in a GxP environment such as pharma means that industry agnostic software platforms are required to be validated before going live. The speed required to adopt new technology because of COVID19 has meant that pharma-specific software platforms that provide validation out of the box are taking center stage.  

We don’t know how long the pandemic will last for but, even after it has ended, we will not return to the old ways of working. Many companies are satisfied with flexible working and will allow this to continue – and there are costs to be saved; downsizing office space, for example. But digitization is not just about enabling remote working. In my view, digital tools allow for significantly improved efficiency and cross-company collaboration. Relying on emails and non-validation file sharing tools for collaborating with your partners leads to poor document visibility, versioning issues, delays, lost information, and poor cybersecurity. One of the most common tools for sharing documentation is email, but emails are a popular entry port for cyber attacks, such as PDF malware. What looks like an uploaded PDF in one’s inbox can carry malicious JavaScript code; once an employee opens the attached PDF, it comprises the entire network. In recent years, a number of pharmaceutical entities, including Merck, Dr Reddy’s, and even the EMA, have been hit with cyberattacks.

One of the digital technologies I am most excited by is distributed ledger technology – often known as blockchain – because it ensures data integrity when documents are being shared. Using a blockchain architecture to underlie all external exchange of data and documentation across your supply chain significantly reduces the risk of cyber attack on your organization. Blockchain is a distributed ledger. A ledger is just a way of record-keeping. It is a reliable way of keeping transactional information and understanding who has performed an action, such as who has uploaded something, downloaded something, or reviewed something. Instead of a single ledger with a single point of failure, there are multiple ledgers that are continuously updated. To compromise the entire distributed ledger, you need to take over the majority of ledgers within the network – and that’s close to impossible. With so many people working from home, we’ve seen an increase in companies looking into blockchain technology – as well as other digital solutions to product their IT infrastructure as more organizations share sensitive GxP information regularly outside their four walls.

As a result of COVID-19 accelerating the use of digital technologies across the pharma industry, I hope that companies will be more proactive when it comes to adopting new technology in the future. By piloting a new process and technology like blockchain in parallel with a current process, you can measure efficiency gains and other benefits more readily. Once you have the results at the end of a pilot, you can build a business case for full implementation more easily and begin scaling up this new technology.