Vault Quality Basics includes QMS, QualityDocs, and Training.
Quality Basics: QMS
Quality Basics: QMS provides a preconfigured environment for managing changes to and deviations from established quality processes.
The following core functionality is available in Quality Basics: QMS:
- Change Planning: Provides change management tools to help you document desired changes, assess their impact, and capture the actions required for change implementation.
- Change Actions: Allows you to create records to track the actions needed to implement a change.
- Extension Requests: Allows you to request formal due date extension approval from Quality Assurance (QA) users
- Approvals: Provides eSignature capabilities for Approvers and QA Approvers to record their signatures throughout the change planning and implementation processes.
- Effectiveness Checks: Allows you to track the impact of changes after implementation.
- Process Deviations: Provides deviation management tools to help you document deviations from established processes, determine their root causes and impacts, and devise plans to correct or prevent the deviation from occurring in the future.
Quality Basics: QualityDocs
Quality Basics: QualityDocs provides a preconfigured environment for GxP quality content management.
The following core functionality is available in Quality Basics: QualityDocs:
- Document Management: Provides management tools for quality documents, including a standard reference model, workflows, and life cycles.
- Security Model: Follows a preconfigured and simplified study-based security model.
- Document Change Control: Provides a mechanism for managing changes across one (1) or more documents.
- Periodic Review: Allows you to set up and manage periodic review processes.
- Controlled Document Templates: Provides tools for creating, managing, and approving controlled document templates for use throughout the system.
- Forms: Allows you to manage forms, including the master templates and completed form instances.
- Collaborative Authoring: Allows real-time collaborative authoring in Microsoft 365.
- Reports and Dashboards: Provides predefined role-specific reports and dashboards.
- Vault Mobile: Allows you to access and perform key functionality with the Vault Mobile application.
Quality Basics: Training
Quality Basics: Training is a preconfigured Learning Management System (LMS) designed for GxP compliance. It provides tools to manage learning content and curricula and to deliver and track assignments.
The following core functionality is available in Quality Basics: Training:
- Training Types: Allows you to build a training matrix to manage document training, external training, and quizzes.
- Training Facilitation: Allows you to manage training assignments using direct assignment, facilitated training, and basic self-enrollment.
- Impact Assessment: Provides Training Requirement Impact Assessments to help you determine the impact that changes have on your training requirements.
- Visual Quiz Designer: Provides a visual editor for designing quizzes.
- Security Model: Follows a preconfigured security model.
- My Learning Tab: Provides a personalized My Learning tab that displays information about a Learner’s required and available training.
- Training Dashboard: Provides predefined role-specific reports and dashboards for viewing the status of training across teams and organizations.
- LearnGxP: Enabled for ingestions of LearnGxP content (requires an additional LearnGxP license).
- Vault Mobile: Allows you to access and perform key functionality with the Vault Mobile application.