For emerging biotech companies, establishing a robust and compliant Regulatory Information Management (RIM) system is a critical early step. While highly configurable enterprise systems offer extensive flexibility, they often require significant investment in time, resources, and personnel for implementation, validation, and maintenance. Veeva RIM Basics presents a streamlined, pre-configured alternative designed to meet the core needs of the industry with an accelerated path to value. This document outlines the key principles and functionalities of the RIM Basics platform. This document is designed for people new to the core Veeva Basics principals to help understand the key aspects of our approach.
Getting Live
A primary distinction of the Basics model is its approach to implementation and validation. The goal is to eliminate lengthy and resource-intensive setup phases, allowing organizations to become operational quickly and efficiently.
Implementation and Migration: Unlike traditional implementations that involve numerous workshops for design and configuration, your Veeva Basics Sandbox (SBX) and Production vaults are provisioned together on the day your contract starts. This allows your team to skip over the time typically required for decisions on configuration and instead focus on internal readiness, such as training and SOP development.
To facilitate your journey to “Business Live”, Veeva Basics provides a tool (the Basics Live Tracker) that will guide you through the necessary steps.. We will also provide you with a simplified, guided migration, which will take you through the process of completing your own migration of legacy data and documents.
Validation and Maintenance: In a traditional model, system validation is a significant workstream, often requiring a dedicated team to manage validation packages for initial deployment and subsequent updates. With Veeva Basics, the validation process is managed on your behalf. All updates, whether from Veeva’s three annual releases or Basics-specific enhancements, are validated by Veeva before being deployed. This ensures the system remains in a compliant state without placing the validation burden on your team. The core activity for each release is to review the Veeva-provided Validation documentation and approve a release memo to document acceptance of the release.
Configuration
Each Basics Vault is based on standardized, best-practices, shared across all customers. This approach prioritizes simplicity, usability, and predictable system behavior.
Standardized Environment
A Standardized Environment: Custom configurations are not permitted within Veeva Basics. Instead, system enhancements are developed for the benefit of all customers, based on collective feedback, evolving industry practices, and new platform features. This ensures that the system evolves in a consistent and controlled manner.
User Management and Data Model: User permissions are managed through pre-defined security roles, designed based on common responsibilities within emerging biotech organizations. This simplifies user administration and eliminates the complexity of designing and maintaining a custom security model. The data model of each application is also standardized and kept current to Veeva’s best practices and capabilities.
Regulatory Data Intelligence: A significant challenge in regulatory operations is keeping administrative data aligned with evolving health authority guidance. This can be a complex and time-consuming manual task. In Veeva Basics, this data is updated by Veeva with each release, ensuring alignment with current guidance and best practices without requiring effort from your team.
Reports and Dashboards: Much time and energy can be spent on designing and building customer tailored reports and dashboards. While Veeva Basics has the same reporting functionality as a Full Veeva Vault, the reports are standardized and can only be created/maintained by Veeva. This ensures that customers can get the key reports they need without workshops and detailed knowledge of reporting frameworks and the data model. The Veeva Basics team uses Veeva Connect and live zoom meetings to brainstorm with the community and derive new valuable reports that are incorporated with the releases.
Getting Help
We want to make sure you get the most out of Veeva Basics! We provide multiple kinds of support to help you easily resolve issues and effectively use our applications.
Role-Based Training
- For ongoing learning, role-based training materials, release-specific training This relieves your organization of the continuous burden of creating and maintaining training documentation.
Detailed Work Instructions
- Detailed work instructions are provided and updated with each release. This relieves your organization of the continuous burden of creating and maintaining training documentation.
24/7 Support
- Call, chat, or email a live agent in Veeva’s Global Service Center. Our agents have a robust understanding of Veeva Basics and can help you whenever you need it.
Connect with Peers
- Use Veeva Connect to engage with a dedicated community of peer emerging biotech companies. You can provide direct feedback, collaborate on best practices, and stay informed about upcoming releases and maintenance activities.
Core Functionality
Veeva RIM Basics is designed with a simple goal: to give emerging biotech companies the essential capabilities for managing regulatory submissions, publishing, and documention, without the extra complexity you don’t need.
Standardized Workflows
- Help you manage document and object lifecycles from creation through approval and archival, as well as key processes, such as authoring, review, and eSignature approvals.
Submission Management
Veeva RIM Basics is focused on the needs of emerging biotechs and provides a curated set of foundational features for regulatory management, without the overhead and complexity of enterprise-level functions that you may not need.
- With RIM Basics, you can create and manage submissions through Content Plans, ensuring a structured approach to Submission assembly and best practices for Publishing.
Additional Information
- Submission Wizard is enabled (and is the only way to make Submissions and Regulatory Objectives) as a Veeva best practice for maintaining consistency across Submissions associated to a given Application.
- Content Plans are to be used (creation of binders is only granted for Submissions Archive and to make a binder from Content Plans) as a Veeva best practice to support better visibility and effeciency when creating a compliant Submission structure.
- Core Data is to be added linearly from the Product Information section starting with a Product Family (Product Family, Product, Product Variant, Product Variant Active Substance, Product Variant Inactive Ingredient, Manufacturer, Active Substance, Inactive Ingredient, Therapeutic Indication, Clinical Study, Study Site, Nonclinical Study) to support a better understanding of the relationshipos between data as well as to minimize the amount of tabs shown in the user interface.
The following are not supported in Veeva RIM Basics:
- Registrations, Events, Activities, Global Content Plans, Active Dossier, and RLCP
- These features are designed for multi-product/multi-region companies. While useful, they would add complexity to smaller companies that are not yet at that scale.
- Submissions for Medical Devices and Animal Health
- Currently Veeva Basics is focused on biotech.
- Dynamic Access Control (DAC) is not exposed to Veeva Basics customers.
- Instead common security patterns are supported out of the box (for example, sensitive content and external users).