About GxPlex - Revision history

Florian Adragna at 19:20, 19 July 2026

2026-07-19T19:20:31Z

← Older revision		Revision as of 21:20, 19 July 2026
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	== About GxPlex ==		== About GxPlex ==



	=== What is GxPlex? ===		=== What is GxPlex? ===

	GxPlex is a collaborative database, organized like a wiki, that brings together legal articles and guideline paragraphs relevant to the preparation, conduct, and reporting of clinical studies — and to clinical research more broadly.		GxPlex is a collaborative database, organized like a wiki, that brings together legal articles and guideline paragraphs relevant to the preparation, conduct, and reporting of clinical studies — and to clinical research more broadly.

	The name can be read as "GxP lex" (the legal side of GxP) or "Gx-plex" (the complexity of the systems and processes involved). Both readings are intentional, and both are true.		The name can be read as "GxP lex" (the legal side of GxP) or "Gx-plex" (the complexity of the systems and processes involved). Both readings are intentional, and both are true.


	=== Why does it exist? ===		=== Why does it exist? ===
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	This structure makes it possible to search by topic and compare how different countries or research scopes handle the same question — something that's normally very time-consuming to do manually.		This structure makes it possible to search by topic and compare how different countries or research scopes handle the same question — something that's normally very time-consuming to do manually.



	=== What are we trying to achieve? ===		=== What are we trying to achieve? ===
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	GxPlex's core functions are, and will remain, '''free to access''''.		GxPlex's core functions are, and will remain, '''free to access'''.

	The goal is reach and impact, ''not gatekeeping''.		The goal is reach and impact, ''not gatekeeping''.

Florian Adragna: /* How is it organized? */

2026-07-19T19:18:40Z

How is it organized?

← Older revision		Revision as of 21:18, 19 July 2026
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	==== How is it organized? ====		==== How is it organized? ====
	References (laws, articles, guideline paragraphs) are entered into the database as contributions, each tagged with information such as:		References (laws, articles, guideline paragraphs) are entered into the database as contributions, each tagged with information such as:
	• Area of validity — region or country		• '''Area of validity''' — region or country
	• Scope — general requirement, IMP, Medical Device, IVD, GMP, GEP, etc.
	• Type of document — treaty, legislative act, guideline, scientific article, etc.		• '''Scope''' — general requirement, IMP, Medical Device, IVD, GMP, GEP, etc.
	• Document name, version/revision, and link to the official source
	• Document part — chapter, article, section, etc.		• '''Type of document''' — treaty, legislative act, guideline, scientific article, etc.
	• Language
	• ~~Topic(s) and category~~/~~chapter~~ within GxPlex		• '''Document name''', '''version/revision''', and '''link''' to the official source
	• Status — current, not yet in force, or superseded
	• Access restrictions — whether the source material is copyrighted (referencing is always allowed; copy-pasting protected content is not)		• '''Document part''' — chapter, article, section, etc.

			• '''Language '''

			• '''Table of content/Modules''' within GxPlex

			• '''Status''' — current, not yet in force, or superseded

			• '''Access restrictions''' — whether the source material is copyrighted (referencing is always allowed; copy-pasting protected content is not)


	This structure makes it possible to search by topic and compare how different countries or research scopes handle the same question — something that's normally very time-consuming to do manually.		This structure makes it possible to search by topic and compare how different countries or research scopes handle the same question — something that's normally very time-consuming to do manually.


	=== What are we trying to achieve? ===		=== What are we trying to achieve? ===

Florian Adragna at 19:15, 19 July 2026

2026-07-19T19:15:40Z

@@ Line 1: / Line 1: @@
 == About GxPlex ==
-GxPlex is a structured document database for regulatory affairs in the medical device industry.
+=== What is GxPlex? ===
-It helps teams manage, review, and approve regulatory documents in compliance with MDR and IVDR requirements.
+The name can be read as "GxP lex" (the legal side of GxP) or "Gx-plex" (the complexity of the systems and processes involved). Both readings are intentional, and both are true.
-=== Purpose ===
+=== Why does it exist? ===
-=== How to use GxPlex ===
+==== How should we go about it? ====
-=== Development ===
+GxPlex takes a different approach: instead of each organization building and guarding its own list, the clinical research community builds one together, openly.
-=== Contact ===
+==== How is it organized? ====
-For questions or access requests, contact the wiki administrator.

Gxplex admin: docs: add how-to links and roadmap link to About GxPlex

2026-06-22T14:59:47Z

docs: add how-to links and roadmap link to About GxPlex

← Older revision		Revision as of 16:59, 22 June 2026
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	* Structured metadata via [[Special:Properties\|semantic properties]]		* Structured metadata via [[Special:Properties\|semantic properties]]
	* Approval workflow for controlled document management		* Approval workflow for controlled document management

			=== How to use GxPlex ===

			* [[Create_new_page\|Create a new page]] — open a pre-filled document form
			* [[Contribute_to_GxPlex\|How to contribute]] — step-by-step guide for authors
			* [[Help_Adding_a_topic\|How to add a topic]] — create a new category that appears on the topics overview

			=== Development ===

			* [[Development Roadmap]] — planned features and open tasks for future versions

	=== Contact ===		=== Contact ===

	For questions or access requests, contact the wiki administrator.		For questions or access requests, contact the wiki administrator.

Gxplex admin: Add placeholder page

2026-06-19T13:25:10Z

Add placeholder page

New page

== About GxPlex ==

GxPlex is a structured document database for regulatory affairs in the medical device industry.

It helps teams manage, review, and approve regulatory documents in compliance with MDR and IVDR requirements.

=== Purpose ===

* Central repository for regulatory documents
* Structured metadata via [[Special:Properties|semantic properties]]
* Approval workflow for controlled document management

=== Contact ===

For questions or access requests, contact the wiki administrator.