THE ZIP FILE
############

This zip file contains the following files:

1. VNeeS Checker Installer (Install.exe)
2. Readme.txt

We recommend to unzip the files first in a temporary folder before running the installation program.

-------------------------------

INSTALLATION PROCEDURE
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1.


- Windows 10: click right the install file and run as administrator !

You can safely leave all parameters at their default values.

Please remove previous versions first before installing this version

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RUNNING THE PROGRAM
####################

After installing the program,
you can start it by clicking Start > programs > VNeeS Checker 3.0 > VNeeS Checker.

After starting the program, select the folder that contains the VNeeS folder
you want to check, by clicking the 'Browse' button.
Then click the button 'Do the check'. After a few seconds,
the summary of the result appears.
You can view the whole report by clicking the button 'View VNeeS Report'.

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KNOWN ISSUES - FREQUENTLY ASKED QUESTIONS
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1.
This Readme file belong to the VNeeS checker 3.1.1

2.
Be sure to select a writeable folder to store the report.
This means that you have to got permissions to write on the folder
where you run the check.

Two examples:
a) On a CD-Rom with a dossier, you can check with the checker, but the report has to be stored elsewhere. 

b) On some network-drives, you may have read-access, but not write-access.
In those cases you also have to save the report elsewhere.


3.
In some cases you can not browse to a given path with the browse-button.
This happens in case of a long path, for example on a network-drive, in a deep sublevel.
This is not an issue of the checker, but a bug in Windows at the browse-functionality.
The workaround for this is to go to the folder via Windows Explorer,
copy the path that is shown above (select the path, do a right-click, choose copy),
go to the checker, click the browse button, click in the box where the path should be,
and tap Ctrl-V to paste the path into the box.
After that, you can continue as usual.


4.
You can keep the VNeeS Report that is generated in the dossier (put it in the add-info folder)
when you send it to the agency.


5.
This program does not include the guidelines. It only shows you where the errors are.
To see what names the folders and files should have, please see the VNeeS guidance.


6. 
To uninstall under windows 7, go to start menu, vnees checker and uninstall right click with admin rights.



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NEW RELEASES
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Major release

A major release occurs when the guideline has an extensive change to e.g. the folder structure.
Major releases can be installed next to other major releases, to allow a easier transition.

Minor release

When the guidelines has a minor change or when there is for some other reason
a new minor release of the program, the new version will be put online. The minor release replaces the 
previous release, always within the minor releases. 
You will be able to download and install it the same way you do it the first time.
You will not have to do an uninstall. The installation of the new version
will simply overwrite the earlier version.


Changelog
#########
3.1.1 Issued March 2023
	Conform to the updated validation criteria 3.1:
	Correction of a bug concerning the subfolder names validation
	
3.1 Issued September 2023
	Conform to the updated validation criteria 3.1:
	Validation of the folder path length is now verified as Best Practice criterion for the folder "add-info" (additional information).
	A warning will be issued for the “add-info” folder, if the total length of folder path for any file within this folder does exceed 180 characters

3.0	Issued January 2022, belonging to VNeeS Guideline 3.0

2.6 	Issued March 2018
	Conform to the updated validation criteria 2.6: File should have the proper extension (.pdf or .PDF), and hidden files are no longer allowed.
	Check on folder structure is adapted to the new folder structure in the VNeeS Guideline v2.6

2.5c 	Issued December 2017
	Correction on check of filenames specified by validation criterion VNeeS_009.

2.5b	Issued June 2017
	Conform to the updated validation criteria 2.5b: Non PDF/A files get a warning.

2.5	Issued April 2017
	Conform to the updated validation criteria: Non PDF/A files get a warning.

2.4b	Issued May 2016
	Solves those users who have a file system which does not support case sensitivity.  The paths in the hyperlinks are now checked 
	without using the case of a filename. There is also a Q&A on the esubmissions website. Applicants should always foresee that in a folder a filename is always unique, 
	no matter the case. 
	
	A leading dot in a hyperlink path is ignored. (was already the case in V2.4)
	Paths starting with a / are flagged as absolute paths, which is a P/F criterion

	Launch actions in the hyperlinks in the bookmarks pane are also trapped - conform the criteria as a best practice. The output pane in the report mentions the type of action 
	in the hyperlink (please see the ISO PDF specs for what we mean with 'action')

	Hyperlinks on a PDF which point to the very same PDF (so itself), are also verified now. 

	
2.4	Issued December 2015
	CTD modules 2 and 3 in the veterinary structures for pharma and immuno dossiers, use of PDF/A flag to skip font embedding, to speed up execution time
	use of Java runtime 32 bit JAVA_VERSION="1.8.0_66"

	besides folders p1 - p2, p3, p4, p5, P6, we can have at the same level m2-* and m3-* where the asterix stands for a string without spaces.  In this string, numbers and hyphens are allowed.  All charachters used for the m2 and m3 foldernames are lowercase (but no error when they are not lowercase).  When m2-* and or m3-* are present (only for pharma and immuno dossiers), then they must have module tocs called respectively m2-toc.pdf and m3-toc.pdf. A TOC in the wrong folder is an error (VNeeS_008). A missing TOC is a warning (VNeeS_BP001) - provided the GTOC is covering the PDF's in this module.   Inside m2 and m3 - all pdf files must be referenced either gtoc or module toc:  Module TOCs are linked to GTOC if present and provide a complete index and functional hyperlinks (VNeeS_010, VNeeS_011, VNeeS_012)   
	The asterix can also be empty in the folder name, in this case the hyphen that is used to separate the optional name component is also not needed (no error no warning).

	what remains for these m2-* and m3-* folders: 
		PF: test on security settings on the PDFs
		PF: the check of VNeeS_13 on file extention (.pdf), 
		BP: Path length calculations for m2 and/or m3 are BP only
		BP: the BP check on hidden files, 
		PF: the version checking of the pdfs (must be from 1.4 to 1.7), 
		PF the allowed characters on the pdf filename VNeeS-15 and the check of PDF corruption (VNeeS_16)
		BP File size larger than 100 MB (warning VNeeS_BP002)
		BP on font embedding IF not PDF/A (VNeeS_BP004)
		BP on Mechanisms used for making inter-document hyperlink (VNeeS_BP003) 

	What is not to be done inside these m2-* and m3-* are folder and file naming conventions according to the CTD naming convention - except the m2-toc.pdf and m3-toc.pdf

	Please note that appearing m2 and or m3 folders inside an MRL dossier is not allowed and will be a technical invalidation

	The PDF/A flag is used to skip the test on font embedding of the PDFs, the PDF/A flag is not used to skip testing of the actions of the hyperlinks.


2.3 	issued April 2015: belonging to validation criteria 2.3.  Introduction of pass and fail and best practice categories of criteria
	use of Java runtime 32 bit 7 update 75 and itext 2.1.7.	


2.2.a 	Issued 18th June 2013: belonging to Guideline 2.2
	hotfix to allow uppercases in the filenames; Update of the Jave runtime: 7u21 32bit. Change of website French agency.  
	Cosmetic changes to installer (list the name of the application in all languages).


2.2	Issued January 2013, belonging to Guideline 2.2

	VNeeS 012: All hyperlinks and bookmarks between two PDFs must be configured as specified in ISO 32000-1:2008. 
	This means that hyperlinks in the tocs need only to contain forward slashes.  
	
	VNeeS 014: The checker will be able to read the PDF version from the PDF following the new NeeS requirements.  
	(sometimes one PDF file stores the version number at two places.   Although exceptionally, these 2 version numbers can be different.  
	Now we read the PDF version as specified in the ISO 32000-1 PDF specification. It is expected that this will be fully transparent for almost all submissions.)
	PDF versions 1.4 to 1.7 are allowed.

	VNeeS 015: multiple hyphens after each other are allowed.  Filenames ending with an hyphen are also allowed.

	VNeeS 017: The checker will be able to report corrupted PDFs

	Technical change: the installer for version 2.2 now contains a Java runtime (32bit 7u11) which is installed in a single step. 
	No need to install a java run time seperately. 

	The criterion 'Files which are larger than 100 MB' is present in the Guideline v2.2 but not in the validation criteria.  
	Therefore, the legend of the Checker output explicitly displays that it is a warning only. 


2.1.b. Issued October 2011, belonging to guideline 2.1

	new: 
	 in immunological dossiers the folders p3\3e-gmo and p3\3e-gmo\3e-annexes can contain files. 


2.1.a: published 8.9.2011 on Anses website. 

	Minor bug fixes and but important reporting functionalities: (pathlength properly calculated, top level folders can contain files, 
	files which are fully OK are displayed with green boxes, reporting is adapted, version is listed in report, proper display of scores, 
	location to store report is automatically filled in) 

	New: corrected Windows 7 install and uninstall. 

	Updated java run time. 


2.1 	issued july 2011 and was a beta version for testing. This belongs to guideline version 2.1 published on the 1.9.2011.  

	New are 
	-   Volumes 5 and 6 for immunological dossiers are taken into account (including verification of associated TOCs working hyperlinks, unreferenced files detection)
	-   TOCs with hyperlinks built with the bookmarks pane are also now detected and checked
	-   Possibility to choose the location of the report on any writable folder or device (so you could run the VNeeS Checker on a network driver, removable device, 
	including when the dossier is stored on a CD/DVD)
	-   Check the presence of external hyperlinks in the TOCs (e.g. websites) and produce an error


2.0 	published on 18.11.2010 belonging to guideline version 2.0 revised in February 2011 


1.0 	belonging to guideline version 1.0 rev 1 published october 2009. 
	First version of checker. 
