DRUMBEAT^®

A thought process applicable to any regulated field.

DRUMBEAT^® Concept (DBC)

A uniquely numbered single thought that describes a required action.

Key DBC — Highest priority Primary DBC for linking purposes.
Primary DBC — A DBC that is highly relevant to its associated document.
Secondary DBC — A DBC of secondary relevance to its associated document.

DrumKEY™ Analysis

A process for analyzing document quality based on a series of predetermined quality attributes with metrics optionally assigned. 

DrumKEY™-1

Rating of a document with no substantial problems: for example, problems that might prove embarrassing during a regulatory inspection.

DrumKEY™-2

Rating of a document with a few identified problems of the kind that should be kept in mind and possibly explained during a regulatory inspection.

Event

Documented evidence, such as input or output data, test results, and instrument readings.

Gap Analysis

A visual presentation that provides a global view of the procedures and policies missing within a specified organizational unit (Single Unit Gap Analysis) or multiple units (Multi-Unit Gap Analysis).

Instructions

Documents that establish or define expectations.

Linking

Assigning DRUMBEAT® Concepts to relate similar procedures and policies to one another and to regulations.

Nontemplate Instruction

Document that does not lend itself to a stereotyped set.

Organizational Unit

A business domain, such as corporation, division, plant site, or department.

Policy

Document describing “what” is to be done.

Procedure or SOP (Standard Operating Procedure)

Document describing “how” a function is performed.

Reviews

Written interpretations, opinions, and conclusions (including approvals, rejections, and editorial comments) based on evaluations of Events or of draft documents, the purpose of which is to provide written evidence that such data or documents have been evaluated for content, completeness, accuracy, or conformance.

Template Instruction

Document that instructs or specifies and belongs to a set of documents, each of which is prepared in the same manner — with similar subject, format, and structure; e.g., a set of Packaging Specifications or a set of Analytical Test Methods.