Regulatory submissions in a digital world

By Jeanie Kwon and Leslie Wan, DXC Life Sciences

Digitization of the regulatory platform has conferred significant benefits for life sciences companies, but it has also brought new challenges, since our industry is heavily governed by standard operating procedures and validated systems to meet regulations. Add to regulations, global language barriers, entrenched ways of working and organizational resistance, and you have a high level of complexity.

In the past, everything was managed on paper — from the development of documentation through the submission process and beyond. The shift to the electronic common technical document changed that, but even with that shift, many processes were managed manually, and access to documentation was limited.

Furthermore, until recently, processes typically involved a series of manual handoffs, for example requiring someone in regulatory affairs to work on a document, make any necessary edits and then hand it off to someone else to handle another process. That person would take the document to his or her desk and make the changes required before someone else in the life cycle handled the next process.

Managing complexities

One of the big changes that digitization has brought is that documents are now sitting in the cloud, and multiple people can access those same documents on the same platform from different locations. That’s an advantage in many ways, but it does have the potential for complications. One of the biggest fears regarding digitized operations is cyber security, particularly with regard to intellectual property. Emphasis must be given to ensuring the secure transfer of sensitive data among your knowledge workers, as well as among you and your partners.

Cyber security needs to be addressed from three angles: people, process and technology. If any of these factors are not effectively handled, risk will inevitably arise.  To start with, the proper foundation is needed, along with the technical infrastructure to support secure environments. In addition, appropriate processes to work with and handle the sensitive data in these environments must be implemented. And of course, people need to be trained on these processes, but they also need to be aware of what to look out for when handling work from a common digital platform.

When there are regulatory or business process changes, all of these need to be revisited, reassessed, and adapted, and all users need to be trained on those changes as well. It has been said that it takes 20 years to build a reputation, but only 5 minutes to destroy it with a data breach. Therefore, ensuring that every link in the chain — the technology, processes and people — is properly managed will be crucial for safeguarding vital data and reputation.

Come and speak with us at Booth 114 about the digital landscape and how it affects business and regulatory processes at the DIA Regulatory Submissions, Information, and Document Management Forum, from February 5 to 7, 2018.



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