Low-effort R package validation solution

With the increasing use of open-source software in clinical research and the growing industry demand for regulatory submissions in R, the validation of R, R packages, and R package versions has become a well-known and intensively discussed challenge.

entimICE ValoRpacks provides an AI-supported solution that enables customers to manage, validate, and deploy R packages within their own systems and processes in a fully compliant manner, while keeping the effort to a minimum.

entimICE ValoRpacks will be released later in 2026; entimo is already demonstrating the capabilities and planning adoption with interested parties.

1–3 days

to adopt ValoRpacks in your organization

< 24h

to validate new packages

20,000+

packages on CRAN eligible for validation with ValoRpacks

Your benefits

Full compliance with full control, made easy

Self-serviced framework

entimICE ValoRpacks empowers organzations to take the management and validation of R packages into their own hands, enabling the provision of validated R packages in accordance with operational needs.

Easy adoption

entimICE ValoRpacks is an opinionated framework, ready to use for any organization within one to three days, while preserving flexibility enables adoption to organizational processes and integration with the relevant systems.

Fully GAMP compliant

entimICE ValoRpacks acknowledges R packages as non-configured software in GAMP category 3 and implements the full GAMP validation cycle for this category. Relevant validation artifacts per package version are created and maintained within entimICE ValoRpacks, enabling instant inspection readiness.

AI-powered speed

entimICE ValoRpacks utilizes modern automation and agentic AI capabilities to streamline the validation process and create compliant validation artifacts at unrivaled speed. With human oversight, new packages can be validated and published for production use within the day.

Seamless scalability

entimICE ValoRpacks is easy to adopt and use, making it accessible for any organization of any size, from small CROs and biotechs just starting the R adoption roadmap up to big pharma firms that already maintain thousands of package versions for regulatory purposes.

Cost savings

entimICE ValoRpacks remains at an affordable, constant cost, no matter how many packages and versions have to be maintained and validated in your organization. The time saved per package validation outweighs the adoption cost in no time.

entimICE ValoRpacks in detail

Your companion for R package validation

A laptop computer showing a screenshot of entimICE FastTrack, a cloud-native statistical computing environment

Web-based guidance
The browser-based user interface guides users by role through the whole process of R package validation to the task at hand.
FAIR repository
entimICE ValoRpacks provides holistic access to browse, search and use all available packages at any time.
Simple integration
entimICE ValoRpacks has native integrations with CRAN, github and other package sources, and can seamlessly integrate with many modern Statistical Computing Environments, such as entimICE FastTrack and the Posit Suite.

Acknowledged tools usage
Tools such as \{riskassessment\}, \{covtracer\} and \{testthat\} that have a broad adoption in the industry are used in entimICE ValoRpacks to produce validation results and artifacts.
Document templates
Relevant validation artifacts are based on customizable standard templates.
Process guidance
The validation process and workflow is implemented according to GAMP under consideration of suggestions from the R Validation Hub.

Triggered retrieval
Whenever possible, validation steps such as information retrieval, document generation and test execution are fully automated and triggered when all requirements are met, thus reducing manual interaction.
Agentic AI generation
Relevant validation artifacts are generated based on available structured and unstructured information, and standard templates with assistance of Agentic AI.
Human oversight
At relevant steps, humans remain in the loop for review, possible modifications and essential approvals.

GAMP compliant validation
The implemented process of R package validation in entimICE ValoRpacks follows the GAMP guideline for non-configured software by the book, assuring customers regulatory compliance at any time.
entimICE ValoRpacks validation
entimICE ValoRpacks itself is developed and validated according to GAMP, guaranteeing that also the system used for R package validation provides full GxP compliance.
Inspection readiness
entimICE ValoRpacks and each single package version inside are always inspection ready; any audit question can be answered within minutes.

Book a demo

FAQs

How is entimICE ValoRpacks different from other approaches to validate R packages?

Besides entimICE ValoRpacks, industry customers currently have the option to either implement a proprierty R validation framework within the organization from scratch (including SOPs, processes and tools) or to outsource the validation of R packages to commercial service providers. The proprietary framework comes with high ramp-up cost and time, and lacks flexibility and scalability. The outsourcing approach comes with considerable recurring costs and offers no flexibility to quickly get new packages when needed.

How is entimICE ValoRpacks deployed and used?

entimICE ValoRpacks can be either provided as a Software as a Service solution to your organization or be hosted as a containerized application inside your organization, either in the cloud or on premise.

Can my organization adjust the process and deliverables for the R package validation?

Yes, entimICE ValoRpacks comes with an opinionated standard workflow and templates that allow customers to get started quickly, but provide full flexibility to adjust templates to organizational standards, and the process to meet customer-specific SOPs.

How is progress on R packages under validation tracked?

entimICE ValoRpacks provides a convenient package repository overview and search capabilities of all R packages in the system, all corresponding available versions, as well as the validation progress and status for each version.

How is the revalidation of new R package versions handled?

The overall process and workflow remains the same for newer versions of previously validated R packages. entimICE ValoRpacks considers the previous validation artifacts and results, and highlights changes from previous versions, significantly reducing human oversight and review efforts.

entimICE® ValoRpacks