BARCELONA, Spain, May 13, 2015 /PRNewswire/ --
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
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. 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 excited to announce the first cloud solution for global registration management," said Katrin Spaepen, Director of Veeva Vault RIM, Europe. "Veeva Vault Registrations provides a global single source of truth, that is intuitive to use and accessible to affiliates worldwide. In providing real-time data tracking and reporting, companies can speed time to market by quickly understanding the impact of product introductions and proposed product changes."
Global registration management is increasingly important for Europe as the European Medicines Agency (EMA) introduces the Identification of Medicinal Products (IDMP) standards for the unique identification of medicines and the exchange of information on medicines. By July 2016 life sciences companies are required to submit product relevant information so health authorities can simplify the exchange of data across the world to enhance patient safety.
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.
• For more on Veeva Vault RIM and Vault Registrations, please visit: eu.veeva.com/RIM
• For more on Veeva Vault Submissions, please visit: eu.veeva.com/Submissions
• Stay updated on the latest Veeva news on LinkedIn: http:// www.linkedin.com/company/veeva-systems
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 eu.veeva.com.
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 http://www.veeva.com under the Investors section and on the SEC's website at http://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