Electronic Document Management 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.

DocDomain, Terrington’s Document Control software (EDMS), was developed to meet the specifications of Document Management in highly regulated environments. DocDomain 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 of our EDMS

Required Reading  – The ‘New Work’ 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.

Document Library –  Newly created & new versions of existing documents can be managed from the ‘library’ section. You can work on any document from here – saving your updates back to the DocDomain 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.

Manage review stages – ‘Documents to Review’ page displays all the documents you are required to review. With DocDomain you can configure the review stages and the number of signatures required at each stage for every document. You can assign reviewers on per document basis or for a ‘group’ document types in the management system. 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. 

Report – DocDomain has four standard reports . Readers reports detail the ‘read status’ per user and per date period, Expiry and Document Reports include a list of document expiry dates, Version info and document status (superseded, expired,  effective etc.). 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.  

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’ would have administrator access and would be able to create new users (or user groups) and roles to the users, create review paths and stages.