GLP Compliance
2-minute self-check

GLP readiness quiz

Ten questions, weighted scoring, honest answer. This is a self-assessment — it doesn't replace an independent audit.

How the score works (visible on purpose)

Formula: score = Σ(weight × answer) / Σ(weights) × 100, where yes = 1, partially = 0.5, no or skipped = 0. Not all questions are equal: the independent QA unit, SOP system, and data integrity are weighted ×3 because they are inspection killers; protocols, training, equipment, and archives ×2; vendor oversight ×1.

Assumptions: the weights encode our editorial judgment about inspection risk, not a regulatory formula. A high score means “likely ready for an independent audit,” not “will pass inspection.”

1. Do you have an independent QA unit — people who audit studies but don't run them?
Why it matters: GLP's structural requirement; inspectors check independence first.

2. Are your SOPs written, approved, current, and actually followed on the bench?
Why it matters: Stale or ignored SOPs are the most common inspection finding.

3. Does every study run from a signed, approved protocol with documented amendments?
Why it matters: Protocol deviations without documentation sink studies.

4. Can you produce training records (CVs, job descriptions, training files) for everyone touching a study?
Why it matters: Personnel qualification is a GLP pillar.

5. Is critical equipment qualified/calibrated on schedule, with records?
Why it matters: Uncalibrated equipment invalidates the data it generated.

6. Do you have a secure, access-controlled archive for raw data, specimens, and reports?
Why it matters: Archive failures are frequent inspection observations.

7. Are your records ALCOA+ (attributable, legible, contemporaneous, original, accurate) with audit trails on computerized systems?
Why it matters: Data integrity is where inspections live or die.

8. Has the lab had any independent audit (internal QA program, sponsor audit, or consultant) in the last 2 years?
Why it matters: Audits find what inspections will find — earlier.

9. Does management demonstrably resource the quality system (budget, authority, QA independence)?
Why it matters: Inspectors interview management; paper commitment doesn't count.

10. Do you audit vendors and CROs you rely on (test article suppliers, contract labs)?
Why it matters: Your GLP program extends to your suppliers.

What the score means

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