Speakers
Description
Software validation is a key part of analyses conducted in a regulatory environment, and it is crucial to document the accuracy, reproducibility, and traceability of the software used for clinical analyses. At Roche, we initially outsourced this effort to an external partner. However, this was a solution far from ideal due to, among others, bottlenecks, a fixed release schedule, and difficulties with processing ad hoc and business-critical validations. Therefore, in 2021, Roche decided to internalize this process by developing end-to-end validation pipelines that validate packages on demand and serve them in the validated packages repository.
In this presentation, we will walk the audience through this process. We intend to detail how the initial assumptions changed and what parts were the hardest, including design decisions, stakeholder alignment, and getting approval from people responsible for validation. We want to illustrate our progression and how it has positively affected us by raising awareness about high-quality R code across many parts of the company.
Furthermore, we plan to show key performance indicators and how they have evolved. The number of packages validated, time required to validate a package, number of pipelines run, etc., all of this led, through constant improvements and gradual replacement of external validation, to an 80% reduction in validation time. Our goal is to provide insights into how the validation process can evolve within the company by sharing the experience we gained, including both successes and challenges we overcame, which may be useful for companies seeking or already walking the same path.
If you used AI tools or services to support the preparation of this submission, please state the name and reason for using each of them.
Grammarly was used to proofread the abstract, which I believe is using AI in its premium version. Other than that, no AI tools/services were used.
Additional Material or Paper
Validation itself has been partially covered in our talk from 2024 https://userconf2024.sched.com/event/1c8z7/deep-dive-into-industry-r-package-quality-assessment-szymon-maksymiuk-lorenzo-braschi-roche?iframe=no with an emphasis on the process itself and the open source parts of it. Now we want to diligently go through the Roche internal approach and how it evolved, what we achieved, and how others can learn from our path.
| Keywords: Please list up to 5 keywords to help us find the right session for your contribution. | Validation, regulated environments, automation |
|---|---|
| Virtual Option | This submission is for onsite presentation only |
| Video Recording | Video sharing is fine |
| The author(s) agree(s) to take responsibility and be accountable for the contents of the submission and is/are authorized to present it. | Confirm |
| Interested in serving as reviewer? | sz.maksymiuk@gmail.com |