User’s Guide

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Role system

Following roles are available:

  • Editor (can create, edit, review, release documents)

  • Viewer (can view documents)

  • Admin (can do, what an editor can do + create/edit users, create root folders)

  • Folder.Edit (can create, edit folders)

  • QM (FUTURE: can release documents)

First steps

Root actions

  • go to table “document type”

  • create a new document type, e.g. “Order form”

  • create a new user for yourself with the role “Editor”, “Folder.Edit” and “Admin”

  • now you can create new users and documents with your personal account

  • logout

Create a new document

  • login as normal user

  • activate the EDIT area (see head menu)

  • click “Create document”

  • select/create a destination folder

  • select the document type and give a title

  • now the document object is created

  • upload documents, add reviewers, add links

Start a release process

  • the owner of the document can start a release workflow

  • go to the document

  • click “Start Release Workflow”

  • now the document cannot be edited anymore, but the workflow can be rejected by you

  • now the other reviewrs/releasers can login and do their review process

  • the last reviewer automatically releases the document

  • if configured in the “document type”, define the original Word document will be converted to to PDF (see Convert Word documents to PDF. )

  • the document is now visible in the VIEW area

Areas

EDIT area

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Scope:

  • allow create/modification of documents

  • allow creation/modification of folders

  • allow linking of documents to folders

  • see your active tasks

  • do reviews

VIEW area

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Scope:

  • allow search/retrieve released documents

Admin area

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Main functions:

  • Create/modify users

  • Create/modify document types

  • Do a system check

  • Activate/deactive admin functions in the normal user context GUI

  • Reject any active workflows

  • Change Owners of documents

User management

Useful activities:

  • Set login method=LDAP to activate ActiveDirectory authorization

  • Set “user is active“=0 to deactivate a user

  • Set roles to allow user activities

  • Set password

document type management

Useful activities:

  • create new document types

  • define the “Doc code” : this is the prefix for the “Document ID”

  • define “Covert Word document to PDF” yes or no : automatically convert a *.docx document to PDF at the end of the document release; the users in the VIEW area just see the produced PDF document; the Word doc must contain VARIABLES, which will be replaced by the database data, like title, Document-ID, version and so on

System Configuration

some important config variables in conf/config.py:

  • workflow.sign.password.need : 0 or 1 : defines if the user must give the password on an approval workflow (electronic signature support) this is required by FDA CFR820 Part11

  • email.send.allow : 0 or 1 : defines, if the system should send emails to the users, mainly in the workflow process

Document and Version features

Uploads

A document contains one or more uploaded files. If the document type flags “Covert Word document to PDF”, tahn the document can only contain one Word document.

Reviewers

The document type defines the number of reviewers or releasers. These users will review/release the version during the approval process.

Audit log

This list shows the important past actions related to the document version.

Folders

Documents are managed in folders. If you are used to a common Computer File explorer software, than you get easily used to it. You can create, cut, rename folders. You can copy document links to one or more folders.

Important: folders are not a feature of the Document. It is just an optional info detail.

Scenarios

Start Approval-Workflow (A04)

Prerequisites:

Following users are planned for approval:

  • test1 (editor of the document)

  • test2 (reviewer1)

  • test3 (reviewer2)

  • test4 (releaser1)

  • test5 (releaser2)

Actions:

  • Start Workflow

  • if email-function is active on the system: All REVIEW-users get an email, the system allows them to review the document version

  • The review-users review

  • After last reviewer: all releasers get an email

  • All releasers do a review

Convert Word documents to PDF

What to keep in mind:

  • there is an example for a proper Word template: see [GIT-PROJ]/doc_src/examples/Template_SOP_v1.docx

  • the PDF conversions takes places at the end of the release process

  • a VIEWER can only retrieve the PDF version, not the Word-version