Epredia Adopts Veeva MedTech Solutions to Unify Change Control Across Quality and Regulatory
Veeva Systems (NYSE: VEEV) announced that Epredia is implementing Veeva Vault Quality and Vault RIM applications to automate quality management and regulatory operations, enhancing efficiency in change control processes. This integration aims to improve collaboration, reduce manual overhead, and comply with diagnostic reporting regulations including 21 CFR part 820 and ISO13485. Notably, Epredia's adoption of Veeva's solutions is expected to streamline product lifecycle management and facilitate quicker market access for diagnostic products.
- Epredia's adoption of Veeva Vault Quality and Vault RIM supports quality management and regulatory compliance.
- The integration reduces manual overhead and minimizes errors in change management processes.
- Epredia expects to enhance product lifecycle management and speed up market access.
- None.
Veeva Systems (NYSE: VEEV) today announced that Epredia, a global leader in precision cancer and tissue diagnostics, is adopting Veeva Vault Quality and Veeva Vault RIM applications to automate change control between quality management and regulatory operations. Veeva MedTech solutions bring together quality and regulatory information on one platform for better transparency across processes and compliance with changing regulations. Now Epredia can unify change control to strengthen collaboration and speed the product lifecycle.
“Veeva MedTech solutions harmonize our global quality assurance and regulatory affairs processes with a single source of content and data,” said Mark Ramser, senior director of global quality at Epredia. “With complete visibility throughout our change management processes, we can make more informed decisions and get products to market much faster.”
Vault Quality and Vault RIM seamlessly connect change control processes to reduce manual overhead and minimize risk of errors. Changes to approved products, manufacturers, and suppliers are managed from end-to-end to better meet diagnostic reporting and visibility requirements, including 21 CFR part 820, ISO13485, and IVDR. Vault Quality handles change control strategies, decisions, and quality document management, while Vault RIM streamlines decision and impact analysis, submission planning and tracking, and document authoring and archiving.
“There is a significant opportunity for MedTech companies to improve how teams across functions work together,” said Jim Diefenbach, general manager of Veeva MedTech. “Epredia is modernizing quality and regulatory processes to simplify the end-to-end workflow for managing product changes and accelerate the total product lifecycle.”
Epredia is adopting regulatory applications Vault Submissions and Vault Submissions Archive, and quality applications Vault QMS, Vault QualityDocs, and Vault Training. Vault Quality and Vault RIM are part of Veeva MedTech, unified suites of cloud applications to manage regulated content and data throughout product development.
Watch the on-demand Veeva MedTech Summit session at veeva.com/MedTechSummit to learn how Epredia is streamlining quality and regulatory processes.
Additional Information
For more on Veeva MedTech, visit: veeva.com/MedTech
Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems
Follow @veevasystems on Twitter: twitter.com/veevasystems
About Veeva Systems
Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 950 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit 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 (including the on-going impact of COVID-19), particularly within 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 October 31, 2020. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210203005096/en/
FAQ
What new applications is Epredia adopting from Veeva?
How will Epredia's adoption of Veeva's solutions impact product lifecycle management?
What compliance regulations does the Veeva system help Epredia meet?
What benefits does Epredia expect from using Veeva's Vault Quality and Vault RIM?
