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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 ...
Historically, most classes of technical documentation lacked universal conformity for format, content and structure. Standards are being developed to redress this through bodies such as the International Organization for Standardization(ISO), which has published standards relating to rules for preparation of user guides, manuals, product specifications, etc. for technical product documentation.
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.
By computing a precision and recall at every position in the ranked sequence of documents, one can plot a precision-recall curve, plotting precision () as a function of recall . Average precision computes the average value of p ( r ) {\displaystyle p(r)} over the interval from r = 0 {\displaystyle r=0} to r = 1 {\displaystyle r=1} : [ 7 ]
Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated [9] as necessary. Instructions and procedures must be written in clear and unambiguous language using good documentation practices. Operators must be trained to carry out and document procedures.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.
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Requirements are usually written as a means for communication between the different stakeholders. This means that the requirements should be easy to understand both for normal users and for developers. One common way to document a requirement is stating what the system must do. Example: 'The contractor must deliver the product no later than xyz ...