Next-generation product suite aligns regulatory processes, driving
speed, agility, and compliance
PHILADELPHIA--(BUSINESS WIRE)--
Veeva Systems kicked off its annual 2015 R&D Summit today with the
launch of Veeva
Vault RIM, a next-generation regulatory information management (RIM)
suite. Vault RIM unites submission documents, published dossiers,
product registrations, and health authority interactions into a single
authoritative source for all regulatory information. The convergence of
RIM capabilities in Veeva Vault’s regulatory product suite will align
disconnected regulatory processes worldwide, dramatically improving life
sciences companies’ speed, agility, and compliance.
Today, regulatory information is captured in a multitude of disconnected
central and local systems that manage everything from product
registrations, regulatory events, submissions, health authority
correspondence and commitments, to published dossiers and more. Industry
research has found the majority of companies have identical and related
information in multiple systems1 around the globe, creating
redundancies and significant duplication of efforts worldwide.
“Disconnected information and systems are among the biggest hurdles that
regulatory faces today,” said Steve Gens, managing partner at Gens and
Associates. “This inefficiency significantly hinders regulatory
productivity and the ability to have a real-time, end-to-end, regulatory
picture.”
Vault RIM is the first suite of regulatory applications to seamlessly
manage both content, such as documents, and data, like registrations and
events. Vault RIM eliminates the artificial division between content and
data imposed by traditional systems, and removes the need for companies
to purchase and integrate a multitude of disparate systems—thereby
reducing cost and complexity. Further, by centralizing
registration-related information across all geographies, companies can
eliminate duplicate data entry and automate many of the manual,
repetitive steps slowing today’s processes.
“With the Veeva Vault RIM suite, companies can unify regulatory
information for a fully integrated view and greater control over agency
correspondence and commitments,” said John Lawrie, director of Veeva
Vault RIM. “This visibility and efficiency can increase alignment and
agility across an organization.”
The Vault RIM suite of applications includes Veeva Vault Submissions,
Veeva Vault SubmissionsArchive, and Veeva Vault Registrations. Vault
Submissions manages the planning, authoring, review, and approval of
documents for submission to regulatory authorities. Vault
SubmissionsArchive stores published submissions in a secure, globally
accessible repository with integrated document navigation and eCTD
submission viewing capabilities. Vault Registrations enables efficient
management, tracking, and reporting of product and registration
information globally, including approval status, variations, and
health-related authority questions and commitments.
“Veeva is ushering in the next generation of RIM solutions, replacing
fragmented and outdated technologies to fundamentally change how
regulatory teams collaborate around the world,” concluded Lawrie. “By
bringing documents and data together in one, easy-to-use system, Vault
RIM will transform the submissions process.”
Vault Submissions has been generally available since 2013. Veeva Vault
SubmissionsArchive, and Veeva Vault Registrations, which round out the
RIM suite, will be available in December 2015.
Also announced today at the 2015 Veeva R&D Summit, the Veeva
Vault Study Start-Up application manages both the content and
activities associated with onboarding investigative sites for clinical
trials. The solution accelerates the critical time to enrolling the
first patient for the first visit.
In other news from the Summit, Veeva announced its partnership
with UL EduNeering to integrate Vault QualityDocs with ComplianceWire®,
a leading learning management system that has been used to train more
than 35,000 FDA investigators. Aligning training curriculum with
regulated content increases inspection readiness and overall quality.
Additional Information
For more on Veeva Vault RIM: veeva.com/RIM
Stay
updated on the latest Veeva news on LinkedIn: linkedin.com/company/veeva-systems
Follow
@veevasystems on Twitter: twitter.com/veevasystems
Like
Veeva on Facebook: facebook.com/veevasystems
About Veeva Vault
Veeva Vault is the first cloud-based
regulated content management platform and suite of applications designed
for life sciences. It spans clinical, quality, commercial, medical,
regulatory, and every major part of a global life sciences company to
ensure one trusted source for content and data across the enterprise.
Helping companies connect securely in the life sciences cloud, Vault
provides complete control from start to finish, as well as the easy
accessibility, visibility, and agility needed to speed time to market.
All Vault applications offer real-time reporting and dashboards; an
intuitive, consumer-web interface; and a true multitenant cloud
architecture that continuously delivers rapid innovation. Today, more
than 190 customers rely upon Vault to manage their most important
content.
About Veeva Systems
Veeva Systems Inc. is a leader in
cloud-based software for the global life sciences industry. Committed to
innovation, product excellence, and customer success, Veeva has more
than 300 customers, ranging from the world's largest pharmaceutical
companies to emerging biotechs. Veeva is headquartered in the San
Francisco Bay Area, with offices in Europe, Asia, and Latin America. For
more information, visit www.veeva.com.
Forward-looking Statements
This release contains
forward-looking statements, including the market demand for and
acceptance of Veeva’s products and services, the results from use of
Veeva’s products and services, and general business conditions,
particularly in the life sciences industry. Any forward-looking
statements contained in this press release are based upon Veeva’s
historical performance and its current plans, estimates, and
expectations, and are not a representation that such plans, estimates,
or expectations will be achieved. These forward-looking statements
represent Veeva’s expectations as of the date of this press
announcement. Subsequent events may cause these expectations to change,
and Veeva disclaims any obligation to update the forward-looking
statements in the future. These forward-looking statements are subject
to known and unknown risks and uncertainties that may cause actual
results to differ materially. Additional risks and uncertainties that
could affect Veeva’s financial results are included under the captions,
“Risk Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” in the company’s filing on Form
10-Q for the period ended July 31, 2015. This is available on the
company’s website at http://www.veeva.com
under the Investors section and on the SEC’s website at www.sec.gov.
Further information on potential risks that could affect actual results
will be included in other filings Veeva makes with the SEC from time to
time.
1Gens & Associates, Next Generation Regulatory Information
Management and Intelligence: Strategy, Investments, and Status, 2014.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151102005537/en/
Source: Veeva Systems