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Product Overview

Computerised systems to manage document control (electronic document management systems - EDMS) are available in a number of formats – from basic to highly controlled, multifunctional, customisable systems.   

In regulated environments the latter format is required as the reading of key documents and keeping a record of who has read a document and when, is not only good business practice but is essential. For example, a fundamental principal of GxP regulations requires that Standard Operating Procedures, Study Plans and Regulatory Guidelines are all read by designated personnel and this reading recorded.

Terrington's Document Control software (EDMS) was developed to meet the specifications of Document Management in highly regulated environments. Terrington’s EDMS allows you to manage complete document control from creation to issue.

A full audit trail, with every event time and date stamped with the users ID, is standard and the application of  e-signatures for review and sign-off are in compliance with FDA 21 CFR guidance for the management of e-documents.

 Key features include:

  • Read - The Home page displays all the documents you are required to read. Tabbed sections and a shortcut to documents "still to read" helps you navigate the page quickly and easily. Electronic signatures allow you to sign a document as “read and understood” without leaving the page. Document read status is colour-coded so you know which documents you still need to read at a glance. For more information go to: Readers Home

  • Manage - Create new, newly imported and new versions of existing documents from this page. You can work on any document from here – saving your updates back to the DocMan database. Document templates associated with each subsection help manage document creation and formatting. When a document is “Ready for Review” click on "Document Control" to sign off and select a primary reviewer. For more information go to: Manage Documents 

  • Review - My Work page displays all the documents you are required to review. DocMan has three review stages; Technical, QA (optional) and Management. You can be assigned as reviewer per section or subsection or for all documents in the management system – you can configure as required. When you have reviewed a document you can sign it off for the next review stage or reject the document and send it back to the creator. For more information go to: My Work

When a newly created document is ready for review or passes through the review process, workflow emails are triggered notifying the reviewer that a document ready for review.

  • Report - DocMan has four Report pages detailing read status per user and per date period, Expiry log and full Document Reports (including Version Info and Audit Log). Powerful search tools allow you to drill down to specific information on who has read a document or not and the review stage of any document in the system. For more information go to: Reports

  • Control - Administration of the Document Management System, including creation of new sections, subsections and document types, can all be controlled via user privileges in the system security settings. Designated super users will have access to an “Administration” button on the web interface.