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The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
A key aspect of specification by example is creating a single source of truth about required changes from all perspectives. When business analysts work on their own documents, software developers maintain their own documentation and testers maintain a separate set of functional tests, software delivery effectiveness is significantly reduced by the need to constantly coordinate and synchronise ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
Besides differences in the schema, there are several other differences between the earlier Office XML schema formats and Office Open XML. Whereas the data in Office Open XML documents is stored in multiple parts and compressed in a ZIP file conforming to the Open Packaging Conventions, Microsoft Office XML formats are stored as plain single monolithic XML files (making them quite large ...
In 2000, Microsoft released an initial version of an XML-based format for Microsoft Excel, which was incorporated in Office XP. In 2002, a new file format for Microsoft Word followed. [9] The Excel and Word formats—known as the Microsoft Office XML formats—were later incorporated into the 2003 release of Microsoft Office.
Writers of a SOW often include requirements that belong in other parts of a contract. Specifically, quantitative technical requirements are addressed in the military specification and work requirements are specified in the SOW, and data requirements (e.g., delivery, format, and content) should be in the CDRL along with the appropriate DID to minimize the potential for conflict.
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