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The agency has a computer application called the Compliance Management System (CMS, or MARC-CMS) that district offices use to electronically submit warning letter recommendations to FDA Centers. All district office must use the CMS to submit the warning letter recommendation, the Form FDA 483 that supports the alleged violations, the ...
The model letters set out below are meant to be sent to web sites (and their service providers) in order to explain the requirements of the CC-BY-SA and GFDL, and to urge compliance. This page is part of Wikipedia:Mirrors and Forks. The original letters on this page were based on User:MyRedDice/Abacci Letter.
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 ...
Legal compliance is the process or procedure to ensure that an organization follows relevant laws, regulations and business rules. [5] The definition of legal compliance, especially in the context of corporate legal departments, has recently been expanded to include understanding and adhering to ethical codes within entire professions, as well.
Malicious compliance (also known as malicious obedience) is the behavior of strictly following the orders of a superior despite knowing that compliance with the orders will have an unintended or negative result. It usually implies following an order in such a way that ignores or otherwise undermines the order's intent, but follows it to the letter.
A statement of work (SOW) is a document routinely employed in the field of project management.It is the narrative description of a project's work requirement. [1]: 426 It defines project-specific activities, deliverables and timelines for a vendor providing services to the client.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
A letter of comfort, sometimes called a "letter of intent", is a communication from a party to a contract to the other party that indicates an initial willingness to enter into a contractual obligation absent the elements of a legally enforceable contract. The objective is to create a morally binding but not legally binding assurance.