NovaManage Overview
Integrated document management and workflow for highly
regulated industries
NovaSoft Modules | Document Management
& Processing
| Enterprise Wide Access to Comprehensive Information
| Administration for Configuration and Security
| Automate Business Processes |
Regulation of Electronic Records and Signatures
NovaManage is an integrated document management and workflow solution
designed to meet the needs of highly regulated and quality controlled
industries, such as the pharmaceutical and medical device sectors.
Our latest release, NovaManage 8, has been developed to meet the needs of
our customers in these markets, strengthening what was already a highly
successful product.
NovaManage:
- Is quick and easy to implement providing a rapid return on investment.
- Makes it easy for users to access all the information they need.
- Defines their use of information while meeting the strictest security
standards.
- Controls the processing of the information to meet regulatory
requirements.

Organizations using NovaManage benefit from reduced costs, easier regulatory
compliance, increased operational efficiency and improved product cycle times as
a result of managing the creation and use of operational information, documents
and processes. Additionally rapid deployment allows your organization to
see a return on investment in the shortest possible time.
NovaManage can be your complete document management solution. It can handle
the full range of document types, enabling you to organize and cross reference
your information and provide access to that information over company intranets
and portals. Integrated workflow facilities enable you to automate document
related processes with the minimum administrative overhead, while enforcing
security and control.
Electronic signature and controlled print facilities can be incorporated to
meet the highest standards for secure documents. Highly regulated industries
such as pharmaceuticals require the most stringent external validation and audit
of their suppliers and their products. NovaManage, and the Cimage
development and service processes supporting it, meet those high standards for
our customers.

NovaSoft Modules
The heart of the integrated document management and workflow solution
User access to documents and workflow inbox
Electronic signature and controlled printing
Customisation of screens, workflows and data areas
Web based search for remote document access
Participation on the web in document review and approval workflows

Acceptance by All Types of
User
NovaManage is simple and intuitive to use, as screens are configured to the
specific information needs of your organization. Most often, users work with
documents as part of a workflow, by referencing their in-tray. By using familiar
terms such as documents, folders, cabinets and desktops, users quickly feel at
home with the organization of the system.
Anyone who needs access to information, or needs to be included in a
documentation process, will quickly and easily be able to use NovaManage with
minimum training, rapidly adding value to processes.
Complete Document
Management and Processing
NovaManage can be your complete document management solution, managing
documents of any type of file, including Word Processing documents, forms with
populated data, redlined drawings, technical documents, raster images, and video
clips.
NovaManage can even include information about documents stored outside the
system, and hardcopy records, handled as non-resident documents.
NovaManage is application independent so you can use it with most viewing,
editing or mark-up tools. Documents are stored in their native format, but can
also be held in multiple formats, which are synchronized throughout the revision
process.
By handling any file type, NovaManage lets you manage the full range of
documents in your organization, so you can maximize the investment in document
management.

Enterprise
Wide Access to Comprehensive Information
Users can search for documents using document attributes such as name of
originator and date of origination; and via fuzzy searches such as "looks
like" and "sounds like". Additionally, you can use content based
retrieval, searching on the basis of key words or character strings in the
document. etc.
Documents can be cross-referenced in a variety of ways and links can be
maintained throughout the life of a document. You can cross-reference documents
so that when one document is requested for viewing or editing, all the companion
documents are copied with it.
For the most comprehensive grouping capabilities, NovaManage lets you create
logical documents, grouping files of any type together like the chapters in a
book.
Flexible Version and
Revision Control
NovaManage enforces control on who has access to documents, and on who can
check out documents to be worked on, at a vault, folder or individual document
level. You can ensure that users are working on the correct document revision,
and NovaManage will alert users if the current revision is already checked
out.
Users can be confident they can find and work with complete, correct and
up to date information. Using the powerful search, organization and control
features of NovaManage reduces error and improves efficiency.
Enterprise-wide access
over the Web
Users accessing NovaManage through a web browser use their in-tray for
progressing tasks such as reviewing, annotating, approving and releasing. In
addition, users originating documents can register documents into the system.
Standard search, view and print functions are also available through a browser.
The web user interface can be customized to meet your organization's standards
for intranets or portals supporting group processes across your organization.
Collaborative working can include all the people you need, regardless of
location.

Simple
Administration for Configuration and Security
Key administration and control features included in NovaManage include:
- Creating and managing users and user groups.
- Assigning security privileges and controlling passwords.
- Identifying the editing, redlining, viewing and multimedia applications
used within work groups.
- Providing access to subsets of the administrative features to privileged
users by means of special administration user groups.
- Amending end-user forms to capture the document attributes you need.
- Creating and amending Workflow models using the Graphical Workflow Builder.
Administrators can closely track and manage usage. For example, you can
monitor individual user sessions, report on current usage, and track what
actions have been taken on a document, and by whom.
Simple to use administration and monitoring without programming matches
the system to organization needs, enforces security, and maintains accuracy,
with the minimum of overhead.
Automate Business Processes
NovaManage enables business process owners to create workflows for
distributing, reviewing, revising, approving and releasing documents. It is an
integral part of the NovaManage solution, and was designed from the outset to
address the needs of administrators and end users for the simple and flexible
control of documents.
Using the Graphical Workflow Builder you can specify the actions, who
performs them, and the order in which they are performed. This can be for a new
workflow, or more typically, based on a library of existing workflow templates
to simplify the process further and enforce organization-wide standards.
Authorized users can quickly and simply create, control and monitor
workflows to reflect the changing needs of new projects and processes.

Match Processes to Your Needs
To simplify the implementation of workflows, there are both system-supplied
actions and user defined actions, so you can implement your own organization's
processes. Users see work folders in their inbox containing the actions they
need to perform and the documents they need. Work folders can also include
Forms, to capture key data about the folder, the documents, or the status of the
process. Users are alerted to the arrival of a work folder though email.
Workflows are both simple to set up and amend, and also flexible enough to
meet the needs of a wide range of processing requirements. Recipients can be
individual users or groups of users, and processes can include both parallel and
serial flows. Task sharing, and specified voting or response thresholds, can be
created to reflect your organizational policies.
NovaManage workflow is a practical ways of balancing simplicity with
flexibility, enforcing control with efficient working.
NovaGMP
for Regulation of Electronic Records and Signatures
The most stringent control of documents is a fundamental requirement of
Good Manufacturing Practice in regulated industries. NovaManage incorporates
these controls in the NovaGMP module, which meets the requirements of the FDA
regulation 21CFR Part 11 for electronic signatures and controlled printing.
Renditioning enables Microsoft Word documents to be converted and stored in
both native and PDF (Portable Document File) acceptable formats. PDF allows
searching of documents for key words and phrases and is readable across many
platforms.
Electronic Signature Manifestation allows tamperproof verification that the
right people have reviewed and approved information. As a document goes through
an approval process, the workflow stores electronic signatures and other related
information about the document and the approval process. When the document is
released this signature history is merged into the released document, where it
can be read and printed.
Controlled Printing allows the status of all hard copy output to be included
in the print as a banner or watermark. Users can clearly see if they have a
draft or uncontrolled copy of a document, as well as other document information
such as who printed the document and when. Access to print functions is strictly
controlled and audited, so users can be notified when new version of documents
have been released.
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