ViSU

Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-Shop

End-to-end regulatory information management on a single platform. The Vault RIM Suite streamlines global regulatory processes on a single, cloud-based platform, enabling life sciences companies to improve visibility, data quality, and agility. Respond faster to changing regulations and increase process efficiency from submission planning to publishing. Coordinate regulatory efforts across HQ, affiliates, and partners within a single RIM system. Ensure teams are developing reliable regulatory content with high data integrity. Veeva Vault Registrations manages product registration data worldwide, including registration status, variations, and health authority interactions. Veeva’s flexible data model accommodates IDMP data points and will continue to support evolving regulatory data standards. Veeva Vault Submissions streamlines submission planning through approval by automating regulatory process steps.