The DRUMBEAT^® Method

The DRUMBEAT^® method is based upon a series of concepts (DRUMBEAT^® concepts) developed in 1977 by the late Ken Chapman to address the many policies and procedures called for by the new, then-pending cGMP regulations. Most original DRUMBEAT^® Concepts were based primarily on 21CFR§211 and §820.

Current DRUMBEAT^® Concepts include international regulatory requirements in GxP (GMP, GCP, and GLP) regulated industries.

DRUMBEAT^® Concepts provide cross-references to international regulatory requirements and form the basis for the DRUMBEAT^® Tools.

DRUMBEAT^® is dynamic, in that concepts and cross-references are updated regularly as regulations change and new DRUMBEAT^® Concepts are identified.

Benefits of Implementing DRUMBEAT^®

• Expedite the development of a Quality Management System
• All SOPs and Policies are linked to DRUMBEAT^® Concepts and DRUMBEAT^® Concepts are linked to Regulatory Extracts (e.g. US, EU, Canada, Australia, Japan, WHO)
  Therefore, all SOPs and Policies are linked to Regulatory Extracts
• DRUMBEAT^® Concepts links are updated when regulations change
  Thus, SOPs and Policies are maintained current with changing regulations
• DRUMBEAT^® Gap Analysis Tools indicate what SOPs and Policies are missing and where they are missing
• DRUMBEAT^® Tools can be used to ensure comprehensive GMP Training