Who Owns the Design History File: R&D, Quality, or Both?

By Christine Pearsall | September 23, 2026 |
Enlil blog post, Who Owns the Deisgn Hisory File: R&D, Quality, or Both?

Key Takeaways Design History File ownership requires R&D technical ownership, Quality process governance, specialist evidence ownership, record custodianship, and one accountable lifecycle owner. R&D owns the technical truth of the Design History File, including requirements, architecture, outputs, verification strategy, failure analysis, and change impact. Quality owns Design History File process integrity by governing design controls,…

Read More