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Question 1 of 27 · Regulatory intensity
Academic / non-regulated research
No formal compliance regime — document however you like.
ISO / general quality standards
Documented processes and internal audits, but no industry GxP mandate.
GLP / GCP-adjacent good practice
Good-practice expectations and data integrity, not full GMP.
GxP / 21 CFR Part 11 / Annex 11
Regulated R&D or QC — electronic records must meet Part 11 / Annex 11.
FDA-submission / clinical
Data feeds regulatory submissions or clinical decisions — fully validated, signed vendor agreements.