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A certificate of analysis (COA) is a formal laboratory-prepared document that details the results of (and sometimes the specifications and analytical methods for) one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses. This document gives assurances to the ...
Failure Reporting (FR). The failures and the faults related to a system, a piece of equipment, a piece of software or a process are formally reported through a standard form (Defect Report, Failure Report). Analysis (A). Perform analysis in order to identify the root cause of failure. Corrective Actions (CA).
All analytical procedures should be validated. Identification tests are conducted to ensure the identity of an analyte in a sample through comparison of the sample to a reference standard through methods such as spectrum, chromatographic behavior, and chemical reactivity. [5] Impurity testing can either be a quantitative test or a limit test.
Analytical procedures include comparison of financial information (data in financial statement) with prior periods, budgets, forecasts, similar industries and so on. It also includes consideration of predictable relationships, such as gross profit to sales, payroll costs to employees, and financial information and non-financial information, for examples the CEO's reports and the industry news.
An after action report (or AAR) is any form of retrospective analysis on a given sequence of goal-oriented actions previously undertaken, generally by the author themselves. The two principal forms of AARs are the literary AAR, intended for recreational use, and the analytical AAR, exercised as part of a process of performance evaluation and ...
Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
In this technique, the response of the sample is measured and recorded, for example, using an electrode selective for the analyte. Then, a small volume of standard solution is added and the response is measured again. Ideally, the standard addition should increase the analyte concentration by a factor of 1.5 to 3, and several additions should ...
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.