ValidR

ValidR

R is an open-source, statistical programming language that allows users to source, analyse and visualise data.  With packages contributed from users across the world, it was initially designed for the academic community but is increasingly being used commercially across a broad range of sectors.  It is one of the fastest-growing development languages in the world, mainly because it is open-source and distributed under a public licence.

The base R language can be extended through the use of R “packages” developed by the R community and released into the public domain.  Much of the success of R is down to these packages but there are several thousand to choose from and many are untested and often poorly maintained.  For companies, particularly those in regulated industries, the open source nature of R can be an issue as there is no guarantee that packages have received formal testing.

ValidR is a product developed by Mango Solutions that is delivering a validated version of this R language into regulated industries.  It is designed to transform a language that, as a standard installation, provides “absolutely no warranty”, into a system whose scripts comply with regulatory guidelines on the qualification and validation of systems such as the FDA’s 21 CFR Part 11.

With one of the largest R consultancy teams in the world and a long history of delivering R consultancy and software products within regulated industries Mango is uniquely positioned to create the ValidR product.   The Mango business and its ISO9001 accredited Quality Management System (QMS) are subject to regular external audits that have helped shape the R validation process.

 ValidR offers risk-free, guaranteed performance.

The ValidR product comprises fourteen pre-defined modules, each containing R packages sourced from CRAN, Bioconductor, or internally produced here at Mango.  These have been chosen for their functionality, quality and longevity in the face of such a rapidly-developing language.

The product is delivered as a single, easy-to-install bundle, delivered both Linux and Windows server environments.  This bundle contains:

  • All validated R packages and their associated tests written by Mango
  • All dependencies for R packages within the validated environment, each of which are subjected to a lower-level acceptance process.
  • Validation reports for each validated R package
  • A full suite of product documentation (including requirements specification, functional specification, technical design, installation guides, user guides, and release note).

In addition, the ValidR subscription provides an annual re-deployment of the ValidR product containing an updated R version, additional packages and an updated test suit.

Customisations

The ValidR product can also be customised in two different ways:

  • Custom ValidR Modules

Although Mango believe strongly that the ValidR is provided with the best-performing R packages, we also understand that organisations may require certain packages for specialised tasks. We provide a validation service for additional packages, charged on a time-and-materials basis.

  • ValidR Enterprise

An additional customisation option which allows a company to validate its own R packages is ValidR Enterprise, an off the shelf, fully validated R platform.

This allows post-deployment in-house validation of R packages, either as additional packages added into the ValidR environment, or to customise tests for specific functionality.  This allows the environment to be re-bundled and deployed internally, and is priced as an extra purchase and subscription fee.

  • Training

Mango Solutions is a leading worldwide provider of R training courses.  All of our private courses and webinars have been designed to complement ValidR, with training modules specifically written covering each ValidR module.

Click here for more information on R training.

Mango Solutions is uniquely positioned to create the ValidR product due to being experts in R and having expertise in providing services within a GxP (validated) environment for a number of Pharmaceutical clients.  As Mango provide software that is used in validated environments, the business and its processes are regularly externally audited and are subject to a Quality Management System (QMS).

ValidR Enterprise

To read a white paper on ValidR Enterprise: Developing an R Validation Framework by Andy Nicholls from Mango Solutions, Click here.

 

 Please contact us to find out more about how Mango can help your company with R Validation.