Regulatory is intended to work and align on topics around pipeline validation and qualification for clinical applications and make these even more complete in terms of testing, standards obeyed and documentation:

  1. Addition of missing tests for modules, subworkflows, workflows where necessary
  2. Checking of guidelines for releasing pipelines, ensuring these are in line with expectations of FDA and EMA for GAMP criteria
  3. Validation of pipelines with standard / benchmark datasets where applicable, additional testing with (in-house) test data to verify status of pipeline
  4. Alignment between different stakeholders with interests in validation & qualification (e.g. Clinical providers, Pharmaceutical Industry, …) to improve standards, fill gaps with respect to FDA/EMA requirements
  5. Establishment of novel approaches to tackle the above, e.g. by additions to nf-core tooling to allow for better generation (automation) of requirements for the above

Depending on interest/activity, other potential activities could be started, as discussed in the meetings of the SIG.


Initial activities will involve a monthly meeting with developers and users, to identify the most relevant problems related to regulatory questions with nf-core pipelines. Future activities may include presentations and discussions from topic-experts, as well as tutorials, workshops, and demo-days of nf-core pipelines with a focus on the above topics.