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As compared to traditional document management systems, Veeva offers 'harmonization with autonomy'
Veeva (Pleasanton, CA), which upended salesforce automation with its cloud-based offering, has been bidding to do the same in other functional areas of life sciences, primarily through its Vault platform. The first, already commercialized product was PromoMats, for collecting and tracking promotional materials; later it offered a family of Vault resources for clinical trial master files, medical communications and regulatory submissions. Now it has enabled software linkages between these platforms, with the goal that documents and data developed (and “owned”) by one functional area in a company, such as the regulatory platform, can link to others, such as manufacturing or marketing.
"The content management industry has tried to solve this problem in the past, sometimes with a centralized, monolithic repository,” says Karin Ondricek, a senior product manager at the firm. “That gives you a single source, but governance becomes a big challenge and inter-dependencies limit how fast teams can respond to change.” Decentralized solutions, on the other hand, provide local control within a department, but provide only cumbersome methods for sharing content. A typical example would be a request from, say, manufacturing for current label content, over to the regulatory group. An email request would be answered with an email and attachment, which gets saved in the requesting department. Now there are three disconnected versions of the same file floating through the IT system.
Such sharing sounds trivial in today’s hyperconnected work environment, but the problem is governance of regulated content. Veeva says its platform can store the metadata with each transfer of a document, so that successive versions, changes and comments can be recorded. (Parenthetically, it’s worth noting the amazing number of recalls originating in label corrections; evidence that this is an ongoing issue for the indsutry.)
Ondricek adds that Vault can be set up to allow controlled access to business partners, such as investigator sites, contract manufacturers and others (although each needs to be a Veeva client, or to have an IT interface that manages the data exchange). The company already has over 100 pharma clients using Vault, with 40 of them using multiple Vault platforms. The clinical-research Vault, introduced early this year, has two of the top 20 pharma companies as clients.