DOXPUB 12-0058-SOP

Summary:

Describes how software is developed and documented so that it is safe, reliable and effective. Applies to the development of software for use in medical device products, or for use in device manufacturing or QA/QC testing and analysis. Intended primarily for software developed within the company. Custom software supplied by a vendor should be developed in accordance with the vendor's software development procedures. Covers software development plans, requirements analysis, test plans, design, implementation, validation, release, versioning and design reviews. Includes provisions for compliance with FDA Guidelines on General Principles of Process Validation, Device Good Manufacturing Practices, ANSI-10.3, ANSI/IEEE Std 730, 829, 830, 1008, 1012, 1016, and III/8283/89-EN (draft).

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 8-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