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“We wanted to find a way to eliminate paper and improve process efficiency while complying with global requirements for a trial master file and adhering to our footprint goal,” explained Tom McGrady, Pharma Start’s vice president of quality assurance. The company turned to Vault eTMF for its flexible cloud architecture, ease of use, and ability to comply with 21 CFR Part 11. Plus, with TMF documents always up-to-date in Vault’s centrally accessible system, Pharma Start is better prepared for audit at all times. “We had a lot of criteria but Vault eTMF met all of them,” said McGrady.
Pharma Start initially considered other eTMF applications, but a cloud solution proved critical in order to remain true to its environmental goal. An in-depth study conducted by Accenture and Microsoft determined that the average 100-person company can reduce energy consumption and emissions by more than 90 percent by deploying all business applications in the cloud. Multitenant cloud applications, specifically, have proven to be greener alternatives to traditional systems, as they serve many customers that would otherwise each utilize their own resources to power, cool, and maintain the required infrastructure. Further, Veeva’s data centers use advanced technologies to optimize temperature control and reduce energy consumption.
“Securely accessible in the cloud and as easy to use as Amazon, Vault eTMF ensures both external and internal teams can fully leverage the system. Everyone can work in parallel so we don’t wait, for example, while physical documents are shipped to sites or a wet signature is captured via courier from locations all around the globe,” explained Rebecca Moraris, Pharma Start’s director of clinical operations. “Vault eTMF also provides total transparency and a better vantage point for sponsors, sites, and internal groups to identify problems early and fix them quickly.”
Since implementing Vault eTMF, Pharma Start has experienced major efficiency gains. “It really comes down to improved productivity,” added Moraris. “With Vault eTMF, processes and workflows can be automated so individual sites don’t have to re-create the wheel but simply pull down a template, complete it, and upload it back into Vault for all to see in real time. Placement into the eTMF happens automatically.”
Moraris continued, “We see tremendous hidden cost savings because TMF documents are uploaded, QC’d, and approved in the system all along the way. For study start-up, there’s less chasing documents and signatures, and at study close-out, we’ll eliminate the painful document reconciliation process.”
Vault eTMF is part of Veeva’s Development Suite, a cloud-based line of integrated content management applications for the life sciences industry. Supporting the R&D process from clinical trials to quality and regulatory submissions, the Veeva Development Suite provides pharmaceutical, biotechnology, and medical device companies the ability to deploy a single content management system globally.
Pharma Start has joined the many life sciences organizations making the switch from paper to an electronic TMF and is working through the common challenges associated with change. “People always fear change, primarily because they worry about a loss of control. We’ve done training and adjusted our SOPs, but truly the best way to help the team make this transition has been to demonstrate the value of Vault eTMF. As soon as they see how much faster, easier, and more efficient it makes their jobs…change is easy. There’s no turning back now,” concluded Pharma Start President Christina Fleming.
For Additional Information:
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