DOXPUB 12-0059-SOP

Summary:

Describes the procedures for the identification, collection, indexing, access, storage, maintenance, and disposition of quality records generated by quality systems. Intended for hardcopy and electronic quality records. Covers storage and retention methods (does not include retention time), storage environments, security, and availability for inspection.

Included Sections:

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

Included Attachments/Appendices:

Matrix of Quality Records, Storage Locations and Index Status

About This Document:

This is not a generic template, it's a 3-page procedure that was actually created and used in the Document Control 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:

• Document Control Personnel
• Configuration Management
• Quality Assurance Managers