Functional description checker - Europa



Functional description and specifications Belgian Checker (as from May 2009)

Primarily focused as an eCTD folder and filename structure checker. This subset of the EU and ICH standard became later the NeeS format. Can be used fully independently from full compliance/zero tolerance.

A. Functional description

Loading of the root folder, checking the structure according to M1 version EU 1.3 and M2-M5 version ICH 3.2.2 for the folder and filenames used. The root folder has a name ‘0000’ to ‘9999’. The checker returns the following output: the number of folders and files, the folder and file score of a dossier, the number of subfolders that contains files and should not, whether a path length was too long, number of files with the wrong name, the number of files with the wrong extension, the number of files that could not be checked because they are in a non-eCTD folder.

The checker produces the best report as an html file with the following error codes: folder cannot contain files, name contains illegal characters, name not conform eCTD guidelines, document has an extention which is not allowed, document cannot be checked correctly because it is on a non-eCTD folder. An error is given when the maximal path length of 230 chars is exceeded. The following warnings are given: document is password protected and/or is not PDF version 1.4 and missing tables of contents (tocs) .

B: Algorithm implemented

B1. First the folder structure is verified:

Verification that all folders (directories and subdirectories) are eCTD folders. The ICH eCTD specification allows for variable folder names (like M5/535-rep-effic-safety-stud/variable. Verify also that each folder name only contains allowable characters. Count those which are not.

Consequently, verify that those folders which must only contain subfolders and no files, really do so. Count the folders which incorrectly contain files while they should not.

Empty folders are not displayed in the report, but are counted in the total number of folders. When an empty folder is not according to the folder name convention, it is not counted as an error.

Verify that the total path length (of the nested folders with the filename, including extension) is not too long (230 chars). A path length which is too large is counted as an incorrect folder in the folder score.

Calculate the ratio of problem folders to the total amount of folders. The root folder (0000) counts as one folder, the util folder is also a folder and within the util, the subfolders /util/dtd count as one folder, as does the subfolder util/style. Variable foldernames as M5/535-rep-effic-safety-stud/variable are included in the total sum of folders.

Node extensions are not allowed.

B.2. Files:

For each of the files: verify that the name of the file is correct, i.e. eCTD specifications, and allowable characters, with the variable part as is indicated in the figure above for module 3. When a file contains illegal characters, it is by definition also excluded being a eCTD filename, the output of the checker indicates both errors for convenience of the submitter, but the file is only counted as a single error.

Verify for each of the files that the extention is permitted (pdf|rtf|css|html|htm|xml

|xsl|jpg|png|gif|dtd|xpt|xls|txt|mod). Count those files for which the extension is not permitted.

Multiple errors (wrong filename and wrong extension) for one file are counted as a single error for the file.

When a folder contains files, while this should not be the case, the folder is counted as an error, but also each of the individual files.

Calculate the ratio of problem files to the total amount of files.

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