GAMP 5 - Good Automated Manufacturing Practice
Development appendices D1 to D11 (requirements, configuration and design, software, testing, system descriptions, data migration, Agile, tools, distributed ledgers, AI and ML) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice D3: Appendix D3 Configuration and Design

Configuration and design specifications are the technical elaboration of the requirements, describing the means by which the system meets them: configuration specifications for configured products define every setting and parameter supporting the business process with the reason and controlling specification, the tools or methods used to set them, dependencies on other systems or modules and on infrastructure such as layered software and operating systems, and the security of the settings, and may be held in electronic systems that have strong configuration management and audit trails where that approach is documented; design specifications for custom applications define the hardware architecture and software design at a high level of modules, interfaces and data flow traceable to requirements and at a low level of module operation, unambiguously and precisely. Tables and diagrams are recommended, a hierarchy of uniquely referenced and traceable specifications suits large systems while combined specifications suit small ones, specifications are structured for traceability from requirements to tests, service-provider specifications are leveraged with a supplementary specification for the company's configuration under a quality agreement, and infrastructure is specified and verified once by a unified approach rather than per system. Contents include an introduction with ownership, contractual status and related documents, an overview including record storage and location, the configuration, hardware design covering the main system including virtual machines and cloud responsibility, storage and data location, peripherals and personal devices, interconnections and networks with protocols and encryption, configuration such as device addresses and mobile lockdown, embedded systems with layout, location, wiring and process diagrams, standards, inputs and outputs, environment and electrical supplies, and software design covering the module description and delivery model, system data defined hierarchically with types, format, precision, accuracy, unique identification, multitenant separation and a data dictionary where used, module descriptions with operation, interfaces, error handling, data mapping and performance, and sub-program details including parameters, side effects, language and version, standards, screens and reports, plus a glossary.

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  • 5.3.1 5.3.1 Transform software requirements into an architecture

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