Achieving High Reliability in Critical Systems

  • Published:
    May 3, 2022
  • Category:
    Case Study
  • Topic:

The Journey to Validation

In a recent presentation for CTO Connection, Apprentice Head of Engineering, Jean Barmash, took his peers on a journey through software validation, sharing best practices and lessons learned from his experience.

CTO Connection is a curated group of senior engineering leaders who discuss relevant topics, exchange feedback and tackle common challenges together. Software validation is just one of the many significant topics that is top of mind for software product teams in Life Sciences.

Validation testing formally documents a product's capabilities, relative to its intended use by the pharmaceutical industry. It is an FDA requirement that must be met before a product can be used within any pharma environment. The validation of enterprise software is a complex process. It demonstrates and documents the implementation of a specific software system to ensure that the software operates as expected.

Project planning and best practices

In this case study, Jean explores Apprentice’s risk-based approach toward validation, offering engineering leaders guidance on how to integrate software life cycle management and risk management best practices in their daily work. He covers the significance of project planning and collaboration between engineering, product and quality assurance teams to ensure a successful result on a reasonable timeline.

What happens after the product “ships”?

As important as the validation process is, the next steps post software release are just as critical. In this case study, Jean explores what happens after the validation process, such as monitoring for deviations, helping customers carry out internal test runs and reflecting on validation processes that would benefit from a deeper investment in resources.

What are the lessons learned

Key takeaways from past experiences allow engineering teams to make necessary changes that increase the success of future validation processes.

Download our case study on reliability in critical systems and learn more about the importance of CEO-level visibility and the ways in which organizations can reduce overhead and get to a continuously validated state.