Definitions

The Active Directory is a Windows-based directory service. It stores information about the network and makes this information available to users and network administrators. It gives users access to permitted resources anywhere on the network using a single logon process. Using an Active Directory to store user information provides integrated authentication and centralized user management.

The Active Directory contains the user accounts, computer accounts, groups and all related credential information used by windows and SharePoint.

Auto Document Naming allows you to configure a schema that is used to automatically rename documents and list items.

Auto Document Naming adds structure and provides conformity to documentation.

The SharePoint Check Out and Check In capability provides multiple benefits that increase security and add clarity to document content and/or metadata modification. They include:

• Avoiding conflict with other users who are working in the same library.
• Maintaining version control. Without check out/check in enabled, a new version is created each time you save the document. With check out/check in enabled, a new version is not created until you check the document back in.
• Prompting you to provide comments defining the modifications, thereby making versioning more meaningful.
• Identifying which documents are currently being edited and who is doing the editing.
• Allowing you to evaluate your changes prior to making them available to others. While a file is checked out to you, the changes that you make are not visible to others until you check the file back in. If you do not wish to save the changes, simply discard the check out.
• Providing the capability of working off line through the use of your local drafts folder.
• Allowing you to check out files directly from Word, Excel, PowerPoint and Visio if you have Microsoft Office 2007 or later installed.

A content type can be defined as a uniquely identifiable set of site columns or settings. As a group, the site columns become a “Site Content Type” which is a manageable and reusable structure that can easily be added to a document library or list.

Multiple site content types can be associated with a document library or list creating a central location for storing items with multiple formats. We refer to a site content type that has been added to a list or library as an Active Content Type. An Active Content Type will continue to inherit any changes applied to the Site Content Type from which it was created, including columns, features, etc. until a user breaks the inheritance. The inheritance is said to be broken when the NextDocs feature configurations are modified for the Active Content Type. Once inheritance is broken, the Active Content Type will no longer inherit NextDocs feature changes made to the Site Content Type from which it was created. It will continue to inherit column and template changes made to the Site Content Type as these are under SharePoint control.

A Site Content Type is available for use in the site in which it was defined and in all related sub sites. For a Site Content Type to be available for an entire site collection, it must be created at the top level site of the site collection.

There are three (3) scope modes that are most commonly used in NextDocs:

1. Entire File, where the entire MS Word file itself is signed. Note that this is not valid for documents of the .docx type.
2. Document Content, where all the text and visible content of the document is signed. Recommended by NextDocs.
3. Containing Section, where the content of the current section is signed.

Section based signatures are useful for MS Word documents that are based on workflow operations. Using section based signatures, each signer edits and signs a specific section and in no way affects the signatures on other sections.

A document library is a type of SharePoint list in which every item has a file, or document, associated with it.

You can create, update, store and manage your documents in a library. Grouping documents into libraries allows you to categorize them, provide descriptive information about them and manage them at a group level. Each library can have its own version settings, permissions, workflows, lifecycle, columns, folders, content types, etc.

Restriction: Not all file types can be uploaded into a SharePoint document library. By default, ASP, BAT, DLL, EXE AND MSI files are not permitted.

The Permissions and Management document library options allow you to define the security settings for your document library.

Permissions refer to a security policy that governs access to documents, folders, libraries, lists, etc. and controls the operations that can be performed on documents or items.

Document Numbering can be enabled and configured in the following environments: active content type; site content type; document library; and custom list.

Since the document numbering template is configured in the environment where it will be enabled, the same template can take on a unique look for each environment. The numeric portion will span the environments such that number one may be in one environment, number two may be in another environment, etc. But, the appearance and the information included in the template can be unique to each environment.

You can configure the document numbering template to suit your business needs. Once the template is created and assigned to an environment, all new documents or list items in that environment will be assigned a unique document number synchronously. Existing documents and list items will be assigned a unique document number asynchronously when they are modified.

You can create multiple document numbering templates to be assigned to the various document categories in your system.

You can have a unique document numbering template for each content type, thus ensuring that all documents of a given content type or category will be assigned unique document numbers.

You can have a unique document numbering template for a site content type, thus ensuring that all content types inheriting from that site content type will be assigned the same document numbering template.

You can have a unique document numbering template for a document library or list, thus ensuring that all items within that list or library whose content type does not have its own template will be assigned a document number.

Document Numbering templates are the basis for the Document Numbering feature. The template defines the increment value and the current index that will be used to determine the value assigned to the numeric portion of a document number.

Document numbers are composed of any or all of the following:

An alphanumeric prefix

A unique numeric value Example: Prefix-001-Suffix

An alphanumeric suffix

The main purpose of the template is to generate the numeric portion of the document number.

The lifecycle configuration settings govern the progress within a lifecycle. They can be used in stages where you do not want the users to promote the document until some action is taken. They may also be used in stages where the operation specified is automatic and you would prefer that the system promote the document as soon as that action completes. The configuration settings provide this level of control.

Additionally, the configuration settings in a lifecycle can be used to ensure that signatures tasks and workflows are completed prior to promotion.

The Lifecycle Status Change settings allow control over the actions that will be performed in each stage of the document’s lifecycle.

The operations settings provide uniform, standardized processing of documents.

A lifecycle template consists of a series of distinct stages. A document passes through each of the stages during its lifecycle. Each stage is created to address the document needs at that point in its formation.

A lifecycle stage includes: a stage Name; Configuration(s) which allow or prevent movement of the document through the lifecycle; and the Operation(s) which govern the document processing.

While the lifecycle template will determine document processing from draft to obsolescence, it is the individual stages that govern the document processing to be performed at each step along the lifecycle. The individual stages give the lifecycle its flexibility to address the immediate needs of the overall document process.

Document Lifecycle uses a template with configurable lifecycle stages to govern how your documents will be processed.

Once you create the template, you can begin adding stages which will contain the configurations and operations that define the template.

You can configure the lifecycle template to suit your business needs. Once the template is created and assigned to an environment, all documents in that environment will be processed uniformly.

Additionally, you can create unique lifecycle templates to be assigned to the various document categories in your system; thus providing individualized processing based upon document category.

Information that is attached to SharePoint content. It provides clues to the subject, audience, and/or intent of your content. Metadata describes other data.

Metadata is structured information that describes, explains, locates, or otherwise makes it easier to retrieve, use, or manage an information resource. Metadata is often called data about data or information about information.

Microsoft Office SharePoint Servicer is an add-on to Windows SharePoint Services (wss). Wss is a free product from Microsoft. MOSS is not free but it provides additional features such as excel services, InfoPath forms server, enterprise content management (ECM) and moss enterprise search.

MOSS is a single, unified suite of enterprise-scale applications that satisfies diverse business-critical needs, such as managing content and business processes and simplifying how people collaborate across boundaries. It supports all of the intranets, extranets, and Web applications across an enterprise within one integrated platform.

Informing interested parties of events that have occurred and that impact specific lists, items or search results or that require specific actions.

An alert on a list or library will notify a subscriber when changes are made to items in that list or library or when content is added to the list or library. To create this alert, you must have access rights to that environment.

You can set an alert on an individual item or document the same as you would a list or library.

The Quiz Author manages activities pertaining to the quiz. They can:

• Create and edit a quiz.
• Promote a quiz through the different stages of its lifecycle (e.g., draft, review, approve, approved, and obsolete).

Contains groupings of Site Content Types. This format functions as a filtering mechanism. When you create a new Site Content Type, it must be created based on an existing Site Content Type which will be known as its parent. It will initially inherit its settings and columns from the parent content type. When you select the group in which the parent is located, the available content types will be filtered to include only those located in that group.

Notice that the Site Content Type Gallery displays the existing types along with their parent type and the location where they were created. Those created on the current site will appear as links that take you to their Content Type Definition screen.

Smart Document Feature (SD) is a NextDocs utility that simplifies the creation and management of regulatory content by automatically completing many operations on behalf of the user. These operations include:

1. Capturing metadata to classify and apply properties to a document.
2. Creating the document using the correct content type.
3. Creating the folder structure (if it doesn’t already exist) within the library and loading the document into the correct folder.
4. Attaching the proper authoring template to the document when it is created (does not apply to uploaded documents.

SD Terminology includes the following:

1. Document Classification is a hierarchical classification that creates a unique key as follows:

Artifact Name

1. Folder Path indicates where the document is stored.
2. Template Name is the name of the authoring template that will be attached to the document. The templates can be found in the NextDocs Template library.
3. Folder Structure is the hierarchical storage structure for Smart Document. It is determined based on predefined rules that link to the Document Inventory List using the Document Classification combination of values. The complete folder structure follows the CTD folder structure. The folder structure is built on an as needed basis as documents are added.
4. Active Pharmaceutical Ingredient (API) is a pharmaceutical drug or a pesticide that is biologically active.
5. Clinical Trial is a trial that is conducted on humans.
6. Nonclinical Trial is a trial that typically is conducted on animals.

A complete Web site stored in a named subdirectory of the top-level Web site. Each subsite can have administration, authoring and browsing permissions that are independent from the top-level Web site and other subsites.

A subsite can be created from the top-level site or from a subsite of the top-level site.

The Training administrator has full control of all aspects of system configuration and editing for employee records.

The Training administrator can:

• Create and edit training roles.
• Edit a limited subset of properties on training records.
• Determine the documents to be trained upon.

The Training administrator cannot:

• Create training records.

The Training Auditor has oversight for the training process and ensures training is being completed as needed.

The Training Auditor can view all training roles, records, quizzes and quiz results.

The Training Auditor cannot:

• Initiate training.
• Modify training roles and records.
• Modify training quizzes.

• Active: Once the training workflow is engaged, the Training Record Status is changed to "Active".
• Enabled: When a "unique" Training Record that requires training is created, it is immediately assigned a status of "Enabled".
• Not Required: If a training item is submitted with a Training Option of "No Training", the Training Record Status is set to "Not Required" for each trainee that has a scheduled or completed training item for a previous version.
• Obsolete: If a new revision of the Training Item is submitted to training, all Enabled or Active Training Records are set to a status of "Obsolete".
• Trained: Once the trainee associated with the Training Record completes the training and provides his username and password, acknowledging that he has Read and Understood the assigned document, the Training Record Status is set to "Trained".

The same basic types of views are available for lists and for libraries: Standard, Datasheet, Calendar, and Gantt.

Each library or list can have multiple views. When you create a view, a hyperlink to the view is added to the view menu which appears directly below the Site Actions menu.

Within a view, you can filter, sort and group your items. Note that filtered items are not removed from the list or library. They are hidden from display.

Each Action in the workflow identifies one task to be completed on the path to achieving the overall objective.