DOXPUB 11-0050-SOP

Summary:

Describes procedure to management, control and assure timely reporting of changes to facilities systems. Applicable to all validated and non-validated systems and equipment for which Facilities is responsible for maintenance and repair that are integral to the facility. Does not apply to portable bench equipment. Includes provisions for assigning facilities change request (FCR) numbers, FCR assessment, FCR approval, and FCR completion.

Included Sections:

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

Included Attachments/Appendices:

Facility Change Request Form

About This Document:

This is not a generic template, it's a 5-page procedure that was actually created and used in the Facilities & Equipment 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:

• Manufacturing Personnel
• Facilities Managers
• Laboratory Personnel