How the System Fits Together

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Most of the system is built around a single structure, and understanding it is the key to understanding the rest of the manual.

Documents are organised in a hierarchy in which each level inherits from the one above, so a setting defined once, such as who may approve a document, applies to everything beneath it rather than being re-entered each time.

Figure 1: Diagram of the QMLogic eQMS document hierarchy

The elements of this structure are:

  • Category
    The top-level grouping under which every document is filed.

  • Master Document
    The parent record. It holds the attributes shared across all of a document's versions: its name, its type (SOP / Work Instruction / Template), and the access settings that determine who authors, reviews, approves, and is trained on it. Every version created beneath it inherits these.

  • Document Version
    An individual document file created under a master document. A master document may accumulate many versions over time, but only one is Effective, meaning in force, at any given moment.

  • Release
    The controlled process that takes a version through review, approval with an electronic signature, a release plan, and training. When a released version becomes effective, the version it replaces becomes Obsolete, so the currently applicable document is never in doubt.

  • Training
    Derived from a released version and its Target Audience. The system generates the training from the audience defined on the document, rather than as a separate exercise, and the audience completes it from the Dashboard.

Several supporting elements work alongside this structure:

  • QMS Inputs
    Uncontrolled source documents used when authoring controlled documents (see QMS Inputs).

  • Content Manager
    Manages reusable Variables and cross-document References within Word files.

  • QMS Template
    The starting files (Empty Word, SOP Template, and so on) from which new versions are built (see QMS Templates).

  • Roles, Working Statuses, Signature PIN
    The supporting configuration that governs access, labels documents, and signs your actions.

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