Veeva Vault Registrations will equip companies with a single solution
to manage product registration data worldwide and prepare them to meet
Europe’s 2016 ISO IDMP reporting deadline
PLEASANTON, Calif.--(BUSINESS WIRE)--
Veeva Systems announced it will launch Veeva Vault Registrations, a
comprehensive solution to manage product registration data worldwide,
including registration status, variations, and health authority
interactions. Veeva is previewing Vault Registrations at this week’s
Drug Information Association eRegulatory and Information Conference. The
new offering will be part of Veeva’s regulatory information management
(RIM) suite that will also include Vault Submissions and Vault
SubmissionsArchive.
A large life sciences company can have upwards of 400,000 registrations
around the world for different products, indications, packages, and
formulations. Typically, its regional affiliates use multiple tools for
registration management and rely upon manual processes to bridge the
gaps, resulting in redundant or missing information. Disconnected,
difficult-to-use systems impede companies’ ability to manage product
registrations, health authority interactions, and compliance, according
to research by Gens & Associates.i
“We are pleased to announce the first cloud solution for global
registration management,” said
John Lawrie
, Director of Veeva Vault RIM.
“Veeva Vault Registrations addresses the significant need for a single
system that is easy to use, accessible to affiliates worldwide, and
provides complete visibility. With Vault Registrations, companies can
speed time to market by quickly understanding the impact of product
introductions and proposed product changes.”
Vault Registrations is part of the upcoming Veeva Vault RIM suite of
applications to manage product and registration information, submission
documents, and published dossiers. Veeva Vault RIM will provide a
seamless and integrated approach to regulatory information management
and includes:
-
Vault Registrations for management, tracking and
reporting of product and registration information globally, including
approval status, variations, health authority questions and
commitments, and certification requests. Planned for release in the
first quarter of 2016.
-
Vault Submissions for authoring, reviewing, approving,
and managing the assembly of submission documents, also for tracking
and exchanging documents between headquarters and affiliates.
Available now.
-
Vault SubmissionsArchive for storing published
submissions in a secure, globally accessible repository with
integrated document navigation and eCTD submission viewing
capabilities. Planned for release in the first quarter of 2016.
Vault Registrations will be available as a stand-alone product, or as
part of the Veeva Vault RIM suite.
John Lawrie
is previewing Veeva Vault Registrations at the Drug
Information Association’s eRI meeting May 11 to 13. For details or to
arrange an interview, contact pr@veeva.com.
Additional Information:
• For more on Veeva Vault RIM and Vault Registrations, please visit: veeva.com/RIM
•
For more on Veeva Vault Submissions, please visit: veeva.com/Submissions
•
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•
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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 275 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 veeva.com.
Forward-looking Statements
This release contains forward-looking statements, including statements
regarding benefits from the use of Veeva’s solutions, demand for Veeva’s
solutions, and general business conditions. 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-K for the period ended January 31, 2015, which is available on the
company’s website at 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.
i Gens & Associates, Next Generation Regulatory Information
Management and Intelligence: Strategy, Investments, and Status, 2014.
Source: Veeva Systems Inc.