{"id":24099,"date":"2016-07-25T11:50:02","date_gmt":"2016-07-25T09:50:02","guid":{"rendered":"http:\/\/help.qualiware.it\/qw-help\/?p=24099&lang=en"},"modified":"2016-08-05T16:55:26","modified_gmt":"2016-08-05T14:55:26","slug":"gmp-electronic-signature-audit-trail","status":"publish","type":"post","link":"https:\/\/help.qualiware.it\/qw-help\/gmp-electronic-signature-audit-trail\/?lang=en","title":{"rendered":"Strong Electronic Signature and Audit Trail"},"content":{"rendered":"

It is necessary to identify which categories contain critical data for GMP, and\u00a0consequently they must include the feature- Strong electronic signature<\/span><\/strong> (ref. Ref. 21 CFR Part 11 pts 11:50, 11.70 and 11.200 \/ EU GMP Annex 11 p.to 14) and the Audit Trail<\/span><\/strong> registration (Ref. 21 CFR Part 11 p.to 11.10e \/ EU GMP Annex 11 p.to 9).<\/p>\n

Once identified these categories, it will be activated the corresponding flag in the “Configuration Documents tab, as shown below:<\/p>\n

\"gmpCategoria<\/p>\n

ELECTRONIC SIGNATURE<\/h2>\n

Managing documents belonging to the GMP categories, it will, as mentioned, the strong electronic signature. This means that the button is pressed for the signing of a document, the user will be offered a form for insert the user name and password.<\/p>\n

\"gmpRichiestaFirmaForte\"<\/p>\n

AUDIT TRAIL<\/h2>\n

Each creating, signing, publishing, reviewing and eliminating operation made on a category GMP will be recorded on the Audit Trail, which consists of a database table can not be modified by the user interface and equipped with tools for the detection of any data modification contained (integrity check).<\/p>\n

The Audit Trail of a document is viewable through a special button in the toolbar.<\/p>\n

\"gmpAuditTrail.02jpg\"<\/p>\n

In addition to the reconstruction of the history of operations performed on a document, the Audit Trail allows viewing the status of the document at the time of the operation, being able to display the data and the file version.
\nThe “column Integrity<\/em> ” will bring a red icon If the data have been edited using external tools to QualiWare.<\/p>\n

\"gmpAuditTrail\"<\/p>\n

NOTE<\/strong>\u00a0In a GMP category is not available the opening, the cancellation of a publication and a review as\u00a0a superuser<\/span>.<\/strong><\/p>\n

Access management to the categories GMP<\/h3>\n

In accordance with 21 CFR Part 11 p.to 11.10g \/ EU GMP Annex 11 p.to 12 you must define the appropriate access to GMP categories,
\npartly to bring compliant the process of permissions’s assignment has been developed a special form (downloadable from the forum) by which “the managers of the processes users” may require to the System Adminiatrators to enable other users to a specific category, as well as the creation or disabling users. The same System Administrators may, from the form, do this, (if they will approve the request).<\/p>\n

The assisgnment may also be made by the traditional way using ” the\u00a0Users and permissions<\/a>\u00a0form”.<\/p>\n

The following operations:
\n– Creating a new user
\n– a user’s deletion
\n– Disabling a user
\n– Modify the flag “Administrator” and “trust” of a user
\n– Changing a user’s login
\n– Changing a user business organizations
\n– Change with the assignment on a recording
\n– Change of the\u00a0assignment on a documentary category<\/p>\n

will be recorded in the Audit Trail.<\/p>\n

To view the log of the changes made you can use the link “Audit Trail”, you see in the following forms of the web version:<\/p>\n

– “Users and permissions”, tab “Users Defining”
\n– “Users and permissions”, tab “Assignment of the permissions ”
\n– “Setting Document Management”, next to the button “Permissions defining”<\/p>\n

Auxiliary operating for the user<\/h3>\n

To ensure the correct excecution of the information flow related document, QualiWare provide some additional controls:<\/p>\n

a) enabling a special flag of the class configuration, you can force the opening in reading of<\/em>\u00a0the file before signing.<\/p>\n

\"gmpFunzAusiiari\"<\/p>\n

b) enabling a special flag in the administration console, you will be advised if the published document is consulting it at the time under review<\/em> .<\/p>\n

\"gmpFunzAusiiar02i\"<\/p>\n

Read for more information also the following articles:<\/p>\n

QualiWare configuration for use in accordance with GAMP guidelines<\/a><\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

It is necessary to identify which categories contain critical data for GMP, and\u00a0consequently they must include the feature- Strong electronic signature (ref. Ref. 21 CFR Part 11 pts 11:50, 11.70 and 11.200 \/ EU GMP Annex 11 p.to 14) and the Audit Trail registration (Ref. 21 CFR Part 11 p.to 11.10e \/ EU GMP Annex…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"ngg_post_thumbnail":0,"footnotes":""},"categories":[63],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/help.qualiware.it\/qw-help\/wp-json\/wp\/v2\/posts\/24099"}],"collection":[{"href":"https:\/\/help.qualiware.it\/qw-help\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/help.qualiware.it\/qw-help\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/help.qualiware.it\/qw-help\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/help.qualiware.it\/qw-help\/wp-json\/wp\/v2\/comments?post=24099"}],"version-history":[{"count":0,"href":"https:\/\/help.qualiware.it\/qw-help\/wp-json\/wp\/v2\/posts\/24099\/revisions"}],"wp:attachment":[{"href":"https:\/\/help.qualiware.it\/qw-help\/wp-json\/wp\/v2\/media?parent=24099"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/help.qualiware.it\/qw-help\/wp-json\/wp\/v2\/categories?post=24099"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/help.qualiware.it\/qw-help\/wp-json\/wp\/v2\/tags?post=24099"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}