The Project - Revision history

Florian Adragna at 20:13, 19 July 2026

2026-07-19T20:13:54Z

← Older revision		Revision as of 22:13, 19 July 2026
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	==== Not sure how to approach a new country or topic? ====		==== Not sure how to approach a new country or topic? ====
	Two starting points:		Two starting points:
	• A list of guiding questions ~~'''''PDF'''''~~ to help you navigate the laws and guidelines of a new country systematically		• A list of [[How_to_start\|guiding questions]] to help you navigate the laws and guidelines of a new country systematically
	• The ~~Themes and Topics~~ page, which lays out the existing ~~table of contents~~ and shows where your knowledge might fit in		• The [[Table_of_Content\|table of content/Modules]] page, which lays out the existing themes/topics and shows where your knowledge might fit in

Florian Adragna at 19:46, 19 July 2026

2026-07-19T19:46:19Z

← Older revision		Revision as of 21:46, 19 July 2026
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	=== The vision ===		=== The vision ===
	GxPlex is meant to become a natural starting point for regulatory questions in clinical research, a place where the answer to "what applies here, and how does it compare to there?" is easier to find than it has ever been, for everyone, not just those with the resources to dig it out themselves.		GxPlex is meant to become a natural starting point for regulatory questions in clinical research, a place where the answer to "what applies here, and how does it compare to there?" is easier to find than it has ever been, for everyone, not just those with the resources to dig it out themselves.


			== How to become part of GxPlex ==

			GxPlex exists because people share what they know.

			There are two main ways to get involved.


			=== Become a Member (free) ===
			Members are the ''heart'' of GxPlex.
			As a member, you can contribute references, add or edit entries in the database, and take part in the forum.

			We're especially keen to hear from you if you can help with:
			* Regulatory requirements from countries not yet covered in the database
			* Regulatory requirements from other clinical research domains (beyond what's currently included)
			* Regulatory requirements we may have missed that are relevant to a specific country or activity


			==== Where to start ====

			Every entry in GxPlex exists to answer a practical question.

			When contributing, keep that in mind:
			* '''a reference should point someone toward the answer they're looking for, not just exist for its own sake'''

			Sometimes the clearest way to do that is to summarize where the answer can be found (for example, by listing the relevant paragraph titles), rather than reproducing a document in full.

			We try to avoid simply copy-pasting whole laws into the database, even if some entries might look that way at first glance.

			The listing of documents themselves, along with their scope and validity, is also a tool in its own right within GxPlex.
			Keeping this part accurate and up to date is just as important as the references themselves, and needs the ongoing attention and care of all members.


			==== Not sure how to approach a new country or topic? ====
			Two starting points:
			• A list of guiding questions '''''PDF''''' to help you navigate the laws and guidelines of a new country systematically
			• The Themes and Topics page, which lays out the existing table of contents and shows where your knowledge might fit in


			=== Become the Licensee ===
			Beyond individual contributions, GxPlex is also looking for an organization willing to take on the licence for the platform, and take over its management going forward.
			This is a fit for an organization that:
			# Has the structure and resources to host, maintain, and develop the platform long-term
			# Shares the goal of keeping GxPlex's core functions freely accessible to the clinical research community
			# Wants to be associated with a resource that can grow into a reference point for the whole field, and is willing to invest in that growth


			Taking on the licence means taking on stewardship of GxPlex's mission and its existing corpus, with the freedom to develop the platform further under the existing principles.

Florian Adragna at 19:35, 19 July 2026

2026-07-19T19:35:36Z

@@ Line 1: / Line 1: @@
 == The Project ==
-GxPlex was started to address the need for a transparent, traceable document management system tailored to medical device regulation.
+=== How it started ===
-=== Background ===
+GxPlex began with [https://www.linkedin.com/in/florian-adragna|''Florian Adragna''], who started building his own reference database while preparing his international GCP courses.
-Regulatory documentation under MDR (EU 2017/745) and IVDR (EU 2017/746) requires structured, versioned, and approved records. GxPlex provides a wiki-based platform optimised for this workflow.
+As the corpus grew, it became clear it could be useful well beyond its original purpose, but turning a personal collection of references into a coherent, structured framework required untangling some genuinely difficult cross-jurisdictional questions.
-=== Goals ===
+That's where [https://www.https://www.linkedin.com/in/ilse-tirry-9bb1757/|''Ilse Tirry''] and [https://www.https://www.linkedin.com/in/virgile-donet-a1616255/|''Virgile Donet''] came in.
-* Traceable document lifecycle from draft to approved
+Their input helped resolve the trickiest points and gave the project a sound structure, one that made the whole thing readable, navigable, and interconnectable rather than just a long list of references.
-=== Status ===
+What had started as one person's working tool became, through this collaboration, the foundation for something designed to be shared.
-The project is currently in active development.

Gxplex admin: Add placeholder page

2026-06-19T13:25:11Z

Add placeholder page

New page

== The Project ==

GxPlex was started to address the need for a transparent, traceable document management system tailored to medical device regulation.

=== Background ===

Regulatory documentation under MDR (EU 2017/745) and IVDR (EU 2017/746) requires structured, versioned, and approved records. GxPlex provides a wiki-based platform optimised for this workflow.

=== Goals ===

* Traceable document lifecycle from draft to approved
* Full-text and property-based search across all documents
* Role-based access for authors, reviewers, and administrators

=== Status ===

The project is currently in active development.