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Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.

A regulatory form is the particular policy instrument a regulation employs to achieve a desired end. In other words, it reflects the mechanisms through which a regulation achieves its intended outcomes (e.g., addressing a market failure).

Regulatory document management software (rDMS) is a software application designed to help life science organizations to manage regulatory documents. The software enables users to author, review, approve, distribute, and archive documents in a controlled, efficient, and secure manner.

Regulatory Documents means the prospectus, annual report, semi-annual report and any other document required under applicable federal securities law to be delivered by the Trust to Fund shareholders.

Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update ...

Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory

Simplistically, a controlled document is a document that must undergo formal review, formal approval, controlled distribution, controlled modification and controlled storage and access. Or, in other words, a controlled document is a document that goes through Document Control processes.

A cornerstone of the quality management system (QMS) is the control of documents. While not a particularly glamorous activity, document control is an essential preventive measure ensuring that only approved, current documentation is used throughout the organization.

For the purposes of clinical trials, regulatory approvals include any approvals by government or health authorities regarding any research that includes human subjects. The majority of clinical trials are subject to Food and Drug Administration (FDA) regulations and human subject protection laws.

The Top 7 Benefits of Document Management SystemsReduced Storage Space.Enhanced Security.Improved Regulatory Compliance.Easier Retrieval.Better Collaboration.Better Backup and Disaster Recovery.Increased Productivity.Mar 19, 2015