§213.194. Laboratory records. — Inbound Citations
21 C.F.R. § 213.194
Statutory Authority
Cited by 1 regulation in release Current.
Citations to §213.194(a)(2)
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(c) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with § 213.194(a)(2). The suitability of all testing methods shall be verified under actual conditions of use.