Quality Connections

Connections

Quality – Clinical Operations

Announced 2023 Status Early Customers 1-10

Automatically share clinical core study data with quality teams and streamline management of clinical trial issues.

  • Study Data: Any Clinical Operations and any Quality—Provide a single source of truth for study, country and site data.
  • R&D Issue Management: QMS and CTMS—Track GCP Deviations in QMS automatically by receiving Clinical Trial Issues from CTMS.

Quality – RIM

Announced 2019 Status Mature Customers 11-50

Automate the coordination of product change control activities by sharing critical data and documents between the Quality (QMS) and Regulatory (RIM) Vaults, speeding up regulatory assessments and ensuring compliance.

  • Product Data: Any Quality and RIM – Single source of truth for product data to ensure consistency and accuracy
  • Enhanced Change Control: QMS and Registrations – Accelerate bidirectional change controls with regulatory impact seamlessly
  • Document Exchange: Quality Docs and Submissions – Share documents across teams and eliminate redundant effort

Quality – Safety

Announced 2025 Status Early Customers 1-10

Automate intake by sharing product quality complaint and adverse event (AEs) data between Veeva QMS and Veeva Safety.

  • Product Quality Complaint Intake: Facilitate intake of PCQs that were originally submitted to Veeva Safety
  • Adverse Event Intake: Streamline intake of AEs that were originally reviewed by Quality