> For the complete documentation index, see [llms.txt](https://docs.videc.de/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://docs.videc.de/june5-3.7/en/gxp-edition.md). # GxP Edition The JUNE5 GxP Edition assumes familiarity with FDA 21 CFR 11 and GAMP-5. GAMP-5 is a recognized standard as a guide for validation. The 21 CFR 11 is a regulation of the FDA (American Food and Drug Administration). The FDA sets requirements for secure storage and capture of electronic records, electronic signatures, paperless record keeping and reporting for the manufacture of products. This 21 CFR 11 regulation is generally used in the following industries: * Biotechnology * Pharmaceutical industry * Food industry In the JUNE5 GxP documents, the retrieval of all records and backup are described in detail. **The GxP Edition includes the following documents:** * JUNE5 21 CFR Part 11 Conformity Statement * JUNE5 GxP Documentation, containing: oJUNE5 in GxP environment oJUNE5 Installation Plan oIf applicable JUNE5 Software Change Notice oJUNE5 Software Specification --- # Agent Instructions This documentation is published with GitBook. GitBook is the documentation platform designed so that both humans and AI agents can read, navigate, and reason over technical content effectively. Learn more at gitbook.com. ## Querying This Documentation If you need additional information that is not directly available in this page, you can query the documentation dynamically by asking a question. Perform an HTTP GET request on the current page URL with the `ask` query parameter: ``` GET https://docs.videc.de/june5-3.7/en/gxp-edition.md?ask= ``` The question should be specific, self-contained, and written in natural language. The response will contain a direct answer to the question and relevant excerpts and sources from the documentation. Use this mechanism when the answer is not explicitly present in the current page, you need clarification or additional context, or you want to retrieve related documentation sections.