GAMP 5 - Good Automated Manufacturing Practice
Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 7.9: Software Production and Configuration

What does 7.9 require?

The supplier sets up and keeps a formal regime for controlling how software is produced, with defined methods and tools and with rules and conventions covering, for example, permitted languages, standards for coding, naming and version control, and it considers the use of code reviews. Existing software is built by documented build processes that allow for changes to hardware, interfaces and peripherals. Where the supplier configures a product, it works to the governing configuration specification and to the applicable guidance and recommendations, as Appendix D4 explains.

Maintained by Gerard BlokdykControl text last updated

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  • 5.1.4 5.1.4 Software development standards, methods and tools planning

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Other controls in Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice

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