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2. Letter of comfort (contract law) - Wikipedia

   en.wikipedia.org/wiki/Letter_of_comfort...

   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.

3. FDA warning letter - Wikipedia

   en.wikipedia.org/wiki/FDA_Warning_Letter

   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 ...

4. Negative assurance - Wikipedia

   en.wikipedia.org/wiki/Negative_assurance

   Negative assurance is not appropriate unless the CPA has made an examination in accordance with GAAS for the accounting period before the current one. This is because the auditor needs evidence that can be related to comfort letter procedures. For negative assurance to be permissible, the evidence must have been gathered directly by the CPA ...

5. Form FDA 483 - Wikipedia

   en.wikipedia.org/wiki/Form_FDA_483

   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 ...

6. Type approval - Wikipedia

   en.wikipedia.org/wiki/Type_approval

   Type approval or certificate of conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements. Generally, type approval is required before a product is allowed to be sold in a particular country, so the requirements for a given product will vary around the world.

7. OMB A-133 Compliance Supplement - Wikipedia

   en.wikipedia.org/wiki/OMB_A-133_Compliance...

   The following is a list of circular letters issued by the US Office of Management and Budget which provide significant information and guidance for Federal agencies, recipients, auditors, and the general public over the use and management of federal funds, operations of federal assistance programs, and agencies' and recipients' compliance ...

8. Legal governance, risk management, and compliance - Wikipedia

   en.wikipedia.org/wiki/Legal_governance,_risk...

   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.

9. Product certification - Wikipedia

   en.wikipedia.org/wiki/Product_certification

   product certifications (many nations) Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications (sometimes called "certification schemes" in the product certification industry).