DOXPUB 09-0006-SOP

Summary:

Describes the procedures for creating a Device History Record (DHR). Intended to assure that the DHR contains complete production history of a finished product, and demonstrates product is manufactured in accordance with the Device Master Record and appropriate regulatory requirements. Covers lot file contents, DHR initiation, review of lot files, and storage and security. Includes provisions for compliance with MDD 93/42/EEC Annex V, and 21 CFR Part 820.184.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

None

About This Document:

This is not a generic template, it's a 3-page procedure that was actually created and used in the Device Engineering operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Engineering Managers
• Quality Assurance Managers
• Engineering Development & Manufacturing Personnel