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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 .
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.
The operations manual is intended to remind employees of how to do their job. The manual is either a book or folder of printed documents containing the standard operating procedures, a description of the organisational hierarchy, contact details for key personnel and emergency procedures.
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s). (ICH E6) Multicenter study. A clinical trial that is carried out at more than one medical institution. (NCI)
Documentation development may involve document drafting, formatting, submitting, reviewing, approving, distributing, reposting and tracking, etc., and are convened by associated standard operating procedure in a regulatory industry. It could also involve creating content from scratch. Documentation should be easy to read and understand.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
(Reuters) -Los Angeles-based asset management firms overseeing more than $4 trillion in assets are grappling with the impact of the region's destructive wildfires on their operations, with some ...
In process improvement, SIPOC or suppliers, inputs, process, outputs and customers (sometimes in the reversed order: COPIS) is a tool that summarizes the inputs and outputs of one or more business processes in table form, with each of the words forming a column in the table used in the analysis.