What does end-to-end really mean: Unravelling industry claims

The 2017 DIA meeting in Chicago, which took place from June 18 to 22, witnessed a fair amount of buzz around Regulatory Information Management (RIM) solutions on the market that are being referred to as “end-to-end.” But what does end-to-end actually mean? And how does this term — and how it is used — resonate with life sciences companies?

Life sciences professionals understand that a content management solution or database is not the same as a publishing solution, and although some synergies could be created, gaps would still exist that could be crucial for end-to-end publishing.

Discussions with companies during the conference demonstrated what end-to-end means for regulatory leaders: it’s about having a writing solution with the necessary templates, combined with the ability to define a document, manage the content within a document, support PDF manipulation and go through the different life cycles of the document. A truly end-to-end solution, regulatory leaders say, needs to support all the regional dossiers, define metadata types and dictionaries, provide tracking capabilities, and transfer the document into publishing software supporting all the regions. It must ensure that the dossier passes all validation requirements, can be submitted to the agency gateway and archived for future reference.

In addition, due to the high demand for outsourcing of submission processing, as well as the continuing trend for companies to conduct frequent mergers and acquisitions, the viewing tool must provide external viewing capabilities regardless of the location of dossier (electronic document management system [EDMS], FileShare, database).

User experience and access control

The user experience is also important. For example, users want to be able to view the submission in similar to the way the agency sees it, including the dossier life cycle.

Access control is another crucial consideration, especially in light of the partnerships and outsourcing relationships that companies have formed. Companies want to know that the system has the flexibility to allow controlled and tiered access to relevant data, as well as the option of inheriting access control at the regional, dossier, module, section and document level.

When talking to regulatory leaders at the conference, we heard comments that solutions which claim to be end-to-end don’t meet the expectations and needs of the regulatory life cycle. Some are moving in that direction, but they’re not there yet.

Another critical element for regulatory leaders is trust and proven capabilities. How long has a solution been on the market? Has it been tried and tested? What are the shortfalls? And what are the risks if a new solution turns out to have gaps that weren’t apparent. Life sciences companies don’t want to be treated as guinea pigs in the search for the next big thing. They want to get their product to market promptly and securely, they want to meet timelines and they want systems’ stability.

“Systems that are new to the market often fall short of expectations due to overoptimistic assumptions,” one regulatory leader told us. “It’s therefore important for us to make sure we give our users a platform that is stable, mature and has proven track record.”

There’s no such thing as a perfect solution, but there is trust and experience. It is concerning that some vendors are making claims that can’t be verified. We believe that the best solutions and the best providers strive for constant improvement and to meet the evolving needs of industry and the constantly changing regulatory climate.

Learn more about DXC Technology’s tried and trusted regulatory business automation tools that provide integrated support for the end-to-end Regulatory Information Management process.


 

Deven Mehta and Sadia Ahmed are product managers with DXC’s Life Sciences Group.

Comments

  1. A useful and interesting discussion. Regulatory leaders also need assurance that downstream labelling and artwork satisfies compliance needs, in particular satisfying local market requirements. See our thoughts on this topic: http://www.kallik.com/blog/keeping-regulatory-affairs-happy-with-compliant-labelling/

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