Dynamic DRUMBEAT^® for Pharmaceuticals Tools

Dynamic DRUMBEAT^® for Pharmaceuticals includes the following easy to use basic DRUMBEAT^® Tools:

Inventory your SOPs

The DRUMBEAT^® SOP Inventory and Linking Report, is the primary data entry form upon which most other forms are based.

Data are entered into The DRUMBEAT^® SOP Inventory and Linking Report to provide a complete listing of SOPs for linking.

Gap Analyses

Using DRUMBEAT^® Gap Analyses, you can determine what SOPs are missing and where.

Two DRUMBEAT^® Gap Analysis forms are included in Dynamic DRUMBEAT^® for Pharmaceuticals:

• Single Unit
• Multi Unit

Once SOPs have been assigned DRUMBEAT^® Concepts you can generate a Gap Analysis using the DRUMBEAT^® Single Unit Gap Analysis form to graphically illustrate what required SOPs are missing at a single plant.

The DRUMBEAT^® Multi-Unit Gap Analysis form can be used to indicate where SOPs appear to be missing across multiple plant sites.

Assessing SOP Quality - Screening Profile

Two methods of assessing SOP Quality are included in Dynamic DRUMBEAT^® for Pharmaceuticals:

• SOP Quality Screening Profile
• DrumKEY™ Analyses

SOP Quality Screening provides a fast method that can be implemented comprehensively and economically to evaluate and profile a large set of documents.

The semi-quantitative results are more subjective than those of DrumKEY™ Analyses, but are helpful in quickly determining resource allocation needs for upgrading documents.

DrumKEY™ Analysis

A DrumKEY™ Analysis provides comprehensive insight into document quality, but can require up to an hour a page even by a DRUMBEAT^® expert.

Hence, the DrumKEY™ analysis is intended to be used sparingly and strategically as an audit tool.

However, the DrumKEY™ quality attributes provide extremely useful guidance for upgrading documents in need of repair.

DRUMBEAT^® System Based Inspection Report Forms

The System Based Inspection Report is designed to enable efficient assessment of the compliance status for a specific plant site and is an easy-to-use tool for documenting the following:

• Availability of SOPs that address each of the elements defined in the compliance policy guidance
• Comments regarding the SOPs or compliance with the SOPs
• Action needed to address any potential compliance issues
• Overall compliance with each of the six systems
• Internal assessment or audit results

System Based Inspection Report Forms included in Dynamic DRUMBEAT^® for Pharmaceuticals are:

• Quality System
• Facility and Equipment System
• Materials System
• Production System
• Packaging and Labeling System
• Laboratory Control System