PRODUCT SHEET

Veeva Quality

Veeva Quality brings together QA, QC, and training on a single cloud platform to enable efficient quality management.

Quality applications exist on a single platform, allowing for the consolidation of quality processes that have been traditionally managed in siloed, disparate systems.

Veeva QualityDocs is the industry-leading GxP quality content management application.

Veeva QMS manages and tracks quality processes such as nonconformances, complaints, CAPAs, change controls, audits, risk management & SQM.

Veeva Training is a compliance-optimized learning management system (LMS) that manages authoring, approval, assignment, and assessment of training materials in one place.

Veeva Validation Management digitizes and manages the end-to-end validation lifecycle, providing a paperless environment for protocol authoring, execution, and final reporting.

Veeva Product Surveillance supports medtech post-market surveillance processes and fully automated adverse event reporting to global health authorities.

Veeva LIMS facilitates quality control activities for GMP manufacturing by unifying QC data management and test execution processes within a single, cloud application.

Veeva Batch Release aggregates data and content from QMS, LIMS, ERP, and regulatory systems to facilitate GMP release and market- ship decisions.

Veeva LearnGxP is an eLearning library of accredited courses and microlearning videos to help organizations meet regulatory requirements and drive personnel development.

Veeva Station Manager is a simple tablet-based application that ensures the right content is available 24/7 for the manufacturing floor.

PRODUCT SHEET

Veeva QualityDocs

QualityDocs is a regulated quality content management solution. Veeva's proprietary GxP content reference model enables best practices and industry standardization. The application manages content throughout its entire lifecycle. It allows internal and external parties to collaborate and share information, such as procedures, policies, work instructions, quality agreements and batch-related documentation, in a controlled manner directly within the system.

PRODUCT SHEET

Veeva QMS

QMS is a cloud-based quality management system designed to manage life sciences-specific quality processes. It provides faster time to value with streamlined processes for handling complaints, nonconformances, audits, quality risk management, supplier quality management, and change control. It also allows external partners to access the system in real time to collaborate on investigations, audit findings, corrective actions, supplier change control and more.

QMS is unified with other Quality Cloud applications, and connects to RIM to coordinate product change control activities, Safety to manage complaints, and CTMS for study-related data used in QMS and protocol deviation management.

PRODUCT SHEET

Veeva Training

Training is a learning management system (LMS) designed to ensure training compliance, qualification, and job readiness. It gives customers tools to manage learning content and curricula, and to deliver and track assignments. Training administrators can build plans with many training types, including documents, videos, eLearning, classroom training, on-the-job training, assessments and more. Managers can track qualification and compliance status using reports and dashboards.

Training is unified with QualityDocs, ensuring access to source content and automating re-training based on changes. Document and training data are easily combined for reporting, and training assignments can be made in QMS workflows.

PRODUCT SHEET

Veeva Validation Management

Validation Management is a digital solution for faster, accurate validation. It streamlines commissioning, qualification, and validation activities across computerized systems, facilities, utilities, equipment, and processes. It facilitates the tracking of system inventory, the management of requirements, and oversight of project deliverables. Validation activities can be easily created and approved, test scripts executed digitally, and traceability and summary reports generated automatically.

Validation Management is unified with QualityDocs and QMS to connect quality events and deliverables.

PRODUCT SHEET

Veeva Product Surveillance

Product Surveillance supports medical device post-market surveillance processes and adverse event reporting to global health authorities including the FDA, European Commission, and Health Canada. It standardizes and consolidates complaint reportability through a global decision tree and manages reporting timelines to ensure compliance.

Product Surveillance also supports fully automated reporting with built-in XML payload generation and electronic data interchange (EDI) gateway. It is unified with core quality processes in QMS.

PRODUCT SHEET

Veeva LIMS

LIMS optimizes batch release testing and stability study management for the quality control lab. It drives detailed sample management, digital test method execution, specification adherence, and review by exception to accelerate the release of product.

LIMS promotes compliance by verifying user qualifications from Training, displaying effective test method procedures from QualityDocs, and initiating quality events directly in QMS, ensuring proper resolution prior to batch disposition.

PRODUCT SHEET

Veeva Batch Release

Batch Release is an end-to-end solution that automates aggregation, reviews, and traceability of batch-related data and content to enable faster, more confident GMP release and market-ship decisions.

Batch Release brings together data and content from QualityDocs, QMS, LIMS, ERP and RIM to simplify collaboration with external partners. It is tightly integrated with and requires QMS and QualityDocs. When used with LIMS and RIM, it offers faster time to value, but can be implemented with third party solutions to centralize all batch release data.

PRODUCT SHEET

Veeva LearnGxP

LearnGxP is an accredited training library that can be deployed with Training or other learning management systems. The library contains interactive eLearning content and microlearning videos on topics such as the Fundamentals of Good Manufacturing Practices, Data Integrity, and Inspection Readiness. It is designed to help life sciences companies meet regulatory compliance requirements and provide professional development on industry-specific topics to their workforce.

PRODUCT SHEET

Veeva Station Manager

Station Manager is a tablet-based application that provides manufacturing operators access to content from QualityDocs. As a supportive element to business continuity planning, Station Manager syncs with QualityDocs when internet connectivity is available to ensure the latest versions of content are accessible even when offline. Station Manager surfaces only the relevant work instructions and procedures for a specific station in manufacturing to ensure operators readily have access to the content they need.