Find Your LIMS
Question 1 of 27 · Regulatory intensity
Academic / non-regulated research
No formal compliance regime — you can ship whatever you want, however you want.
ISO 9001 / general quality standards
Documented processes, internal audits, but no industry-specific regulator.
ISO 17025 / accreditation-level testing
Calibrated equipment, traceability, formal method validation — but not GxP.
GxP-adjacent (GLP / preclinical / CDMO development)
Some 21 CFR Part 11 audit trail and electronic signature scrutiny; full GMP may apply to specific workflows.
Full pharma GMP / 21 CFR Part 11 / EU Annex 11
Batch release, audit-ready, regulator-inspectable — the highest compliance bar.