The 4 pillars of a Validated Platform

  • Validated SCE
  • Life Sciences

By Ian Amaranayake

Statistical Computing Environments (SCE) have been around for a number of years and come in all different shapes and sizes. Off the shelf or bespoke, prescriptive or fully flexible, many Pharmaceutical organisations have invested in solutions.

But just why are validated SCE’s important to organisations? Here are four key pillars that should be at the heart of your decision making when selecting the right SCE for you.

1. Controlled and Secure

Centralised platforms enable effective governance ensuring platform changes are controlled, software licensing and packages can be managed and curated and standards can be enforced.

What benefits do users see? By centralising data and programming resources, we enable programming teams to collaborate, share and deliver results faster and more efficiently.

2. Flexible 

We know that one size does not fit all. It is important that organisations find environments that are flexible and fit their business needs without requiring the timescales and costs associated with delivering a bespoke platform. Think of it as a shopping list: 

  • What does your ideal analytical tool workbench look like – SAS, R, Python.
  • Where would you like it to be hosted – On-Prem, in your cloud, or as a service.
  • How many environments would you like – Production, Dev-Test.  
  • How would you like your users to connect – Single Sign-On (SSO), Local accounts.
  • What source and version control system would you prefer – Git, Subversion.
  • How would you like to work with your data – connect to databases, FTO to transfer files.

3. Democratised

Study teams are increasingly looking to adopt modern toolsets – the right tool for the job. Additionally, the need to de-risk vendor lock-in whilst still enjoying end-to-end solutions which integrate well is being seen as a must have. A modern SCE should facilitate that by providing a workbench of applications that support the analytical, reporting, exploratory and data science use cases and user roles within an organisation. 

4. Validated

Organisations within the pharmaceutical industry need to be confident that the results produced through SCE’s can be trusted. Validation is at the very heart of ensuring platforms are fit for purpose and that they have been delivered to quality. Essentially, we need to be confident and able to prove that our SCE’s do what they say they do.

Our flexible validated SCE offering provides a validation framework which governs both the usage and maintenance of the platform, ensuring compliance with regulation such as the FDA’s 21 CFR Part 11. 


Validated platforms offer key advantages. Centralized systems boost team collaboration and speed up results. By tailoring a solution to your needs across these 4 pillars you can streamline your analytics journey, making it efficient and reliable without added time or cost. It’s not just about understanding the point but also proving it.

If you would like to know more about how we have helped CRO’s, Biotechs, and Pharmaceuticals improve their Validated SCE or discuss Katalyze Data’s SCE offering Please reach out to us for a free consultation. 

Back to Insights

Talk to us about how we can help