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Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation; Collectively, these and other good-practice requirements are referred to as "GxP" requirements, all of which follow similar philosophies. Other examples include good guidance practice and good tissue practice.
A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. [1] SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.
Business rules represent the primary means by which an organization can direct its business, defining the operative way to reach its objectives and perform its actions.. A rule-based approach to managing business and the information used by that business is a way of identifying and articulating the rules which define the structure and control the operation of an enterprise [1] it represents a ...
Pro forma financial information is the focus of AT-C section 310. [29] Compliance or an assertion of compliance regarding laws, regulations, rules, contracts, or grants, is the focus of AT-C section 315. [30] Management's discussion and analysis (MD&A), which are presented in annual reports to shareholders, is the focus of section 395. [31]
Data requirements can also be identified in the contract via special contract clauses (e.g., DFARS), which define special data provisions such as rights in data, warranty, etc. SOW guidance of MIL-HDBK-245D describes the desired relationship: "Work requirements should be specified in the SOW, and all data requirements for delivery, format, and ...
Compliance refers to adhering with the mandated boundaries (laws and regulations) and voluntary boundaries (company's policies, procedures, etc.). [ 9 ] [ 10 ] GRC is a discipline that aims to synchronize information and activity across governance, and compliance in order to operate more efficiently, enable effective information sharing, more ...
Basically, this section requires that, as per A-102 Common Rule and OMB Circular A-110 regulations, equipment must be used in the federal program it was bought for, or—when appropriate—other federal programs. Additionally, the recipient must keep equipment records, perform a physical equipment inventory at least once every two years, and ...
328 et seq. Specific requirements for over-the-counter (OTC) drugs. The 500 series are regulations for animal feeds and animal medications: 510 et seq. New animal drugs; 556 Tolerances for residues of drugs in food animals; The 600 series covers biological products (e.g. vaccines, blood): 601 Licensing under section 351 of the Public Health ...