Table of Contents

Modernized Quality Control With Veeva LIMS

Veeva LIMS enables quality control organizations to drive increased efficiency and optimize batch release testing, ultimately improving scalability and ROI. It drives digital method execution, specification adherence, and review by exception to accelerate the release of product.

LIMS promotes compliance by verifying user qualifications from Vault Training, displaying effective test method procedures from QualityDocs, initiating lab investigations directly in QMS from out-of-specification (OOS) results, and displays relevant quality events from QMS during review.

Business Benefits

  • Increase effective lab capacity.

    Increase right first time. through a simple, unified experience.

  • Reduce time to market.

    Increase productivity and reliability while reducing cycle time with unified QA and QC processes.

  • Deliver a modern user experience.

    Improve collaboration, usability, and visibility with a unified lab solution.

Features

  • QC Batch Disposition

    Manage the end-to-end QC Batch disposition workflow, including batch definition, QC sample management, test assignment and execution, specification evaluation, multi-level review by exception, generation of the Certificate of Analysis (COA) and publication of outcomes to Vault Batch Release.

  • Stability Study Management

    Design, execute, and oversee stability studies with inventory and time point pull management, test assignment and execution, specification evaluation, multi-level review, and generation of time point and study summary reports.

  • Sample Management

    Track samples from collection to storage and receipt in the lab. Print labels and maintain current location.

  • Digital Method Execution

    Perform digital method execution following the effective test method procedure rendered on screen, ensure compliant usage of instruments, equipment, and consumable inventory, retrieve data from instruments, and perform calculations.

  • LIMS Master Data Change Management

    Reduce administrative burden and cost, and improve change control execution by centralizing the management of LIMS changes. LIMS automates the identification of records related to a change and facilitates accurate up versioning of impacted data objects to reduce the impact of business changes on the QC lab.

Veeva Quality Cloud

Veeva Quality Cloud enables the management of quality events from event origination to changing controlled content and completing training on a single cloud-based platform. Connecting quality processes, critical documentation, and training—with Veeva QMS, Veeva QualityDocs, and Veeva Training—accelerates and streamlines event identification, correction, and change management. This end-to-end visibility equips organizations to respond to quality events faster, and provides a complete picture of quality management activities to regulators.