Definition
A statement that the material and its result are for laboratory research purposes, and that no result establishes clinical safety, efficacy, sterility, regulatory status, or fitness for use in or on a person or animal.
About records, review, and reporting
The vocabulary of the paperwork: what a certificate is, what governs it, and what it cannot be moved to.
Certificate of AnalysisSample IDChain of custodyScopeScope reviewFeasibility reviewSystem suitabilitySpecificationVerification recordData integrityISO/IEC 17025