Kris Sæther and Andreas Jordell at Xait discuss how to keep
on top of the workflow when multiple contributors are working on the
same document
What are the common characteristics of documents such as clinical
submissions, proposals, procedures, manuals and financial reports? Most
importantly, they are business critical documents that are published
externally or shared internally, making quality of content an essential
feature, and installing stringent requirements on availability,
accessibility and security.
These are large documents that can span several hundred pages,
making them complex to produce. A typical creation process draws
resources from every part of the organisation, requiring the
collaborative and simultaneous effort of multiple writers. Different
personnel are involved in different phases of the creation process, and
documents often go through a predefined workflow of review and
approval, where responsibility and control is passed from one person to
another.
Consequently, many organisations struggle to maintain control.
Finalising a document on time and with satisfactory quality is a not a
trivial task and requires a great deal of coordination. Confusion often
arises. Who is doing what and when will they do it? Which version is
the current version and who holds it? Who is responsible for making
sure that formatting, layout and numbering is consistent across the
document? How are attachments included?
Following its creation, a document and the information contained
within must be managed. This may involve publishing, updating,
recycling, storing and deleting data. The common term for these
activities is ‘information lifecycle management’. With the rapid growth
of information, managing it is becoming an increasingly complex task in
itself.
Furthermore, today’s global companies are characterised by having
organisations spread over large geographical areas. Tasks are assigned
across organisational branches, countries and time zones. This only
adds complexity to the challenges represented by document production
and information management.
Organisations across the globe are starting to recognise that to
successfully and effectively produce and maintain their
business-critical documents, traditional tools, such as word processors
and document management systems, do not suffice, and consequently they
are looking for new and more intelligent solutions. Finding the right
tool and then implementing it in an organisation is not a trivial task.
In this article we explain why organisation should explore the world of
document collaboration systems, but first we take a closer look at CROs
and their specific requirements pertaining to document production.
CROs: IN SEARCH OF BETTER TOOLS
Production of clinical research documentation is becoming a
fastexpanding industry, driven by the growth of biotechnology and the
inclination of the pharmaceutical industry to outsource trial
management to CROs in order to become more cost efficient.
A key priority is to produce clinical research documentation that is
clear and comprehensive, as this allows for faster decision making. The
more efficiently the documentation can be produced, the better.
Clinical documents and submissions require ongoing review cycles and
approvals. The production process must be transparent, with an
auditable log of events available. Edit checks are important to
minimise entry errors.
At the same time, flexible job options (working from home or
part-time employment, for example) are becoming commonplace. With an
increasingly flexible workforce, working in different cities, or indeed
countries, it becomes increasingly challenging for the company to
maintain control of the document production process.
As for proposal documents, Big Pharma now outsources approximately
two thirds of its clinical trial management to more than 1,000 CROs
around the globe (1). For the CROs, the pressure is on to deliver
proposals on time, with excellent quality, in order to win new clients
– or retain existing business. A proposal won’t win the business, but
can lose it in a heartbeat. This is why it is important that CROs that
are aiming to win more business have access to the best equipment in
the toolbox.
THE SOLUTION: DOCUMENT COLLABORATION SYSTEMS
Document collaboration systems allow documents to be edited
simultaneously by multiple authors without fear of overwriting or
duplicating work. Every team member accesses the same instance of the
document, eliminating version confusion. Automatic formatting,
numbering and layout ensures adherence to corporate guidelines and
brand consistency, and allows writers to focus solely on content.
Documents can be accessed from any computer through the internet,
without any software installation, allowing contributions to be made
from multiple locations and organisations. Project managers have
complete control of the production process, assigning tasks and setting
deadlines, tracking changes and assessing their status. Documents are
therefore produced faster, allowing time to improve the quality of
content or increase output.
Document collaboration software provides functionality to manage the
post-production phases of the document lifecycle. All features are
integrated into one system, reducing the total cost of ownership,
facilitating high adoption rates among users, and enabling quick
time-to-value for the company.
TRADITIONAL WORD PROCESSORS: ESSENTIALLY ADVANCED TYPEWRITERS
A descendant of the typewriter and early text formatting tools, word
processing was one of the first office applications for the personal
computer. Today, a typical word processor has functionality for text
editing, spell checking, reviewing, typesetting and other layout
manipulations, creation of images and graphics, and automatic
generation of indices, tables of contents, and so on.
As a result of its heritage, the word processor was created for a
single writer and their requirements – to make frequent edits in the
document as it was developed without other methods of correction.
Although a major efficiency improvement in its own right, the word
processor was never intended as solution to the collaborative
challenges mentioned above. The lack of functionality to support
collaboration continues to be a common denominator of most word
processing software sold today, from Microsoft Word, the most widely
sold word processing system, to OpenOffice.org’s ‘Writer’, the
open-source alternative.
A true collaborative writing application includes all the common
features of a word processor, but is designed from the ground up,
focusing on textual collaboration and workflow – that is the assigning
of responsibilities and deadlines to different writers. This helps
automate the collective creation process, while removing the
inefficiencies often associated with the use of traditional word
processors, such as lack of visibility and control, and difficulties
with maintaining consistent formatting and layout.
STORING INFORMATION IN FILES IS INEFFECTIVE
File-based storage is an intrinsic property of word processors. The
challenge is that files are ineffective repositories for information:
as the amount of information stored inside a single file increases, the
accessibility and readability of the file is reduced – both from a
human and a computer perspective. Navigating a document of 100 pages is
tedious. It is not possible to reuse parts of the document without
dealing with the whole file. And, as more figures and pictures are
added, it is more likely that the software will crash.
Databases are much more effective repositories for large amounts of
information, as data is stored across a multitude of small ‘information
containers’. The increased granularity is a huge advantage when it
comes to features such as accessibility, security and control. Document
collaboration software built on top of databases is capable of focusing
on the information in its own right, not the file that contains them.
It is, therefore, very simple, for instance, to rearrange and reuse
information.
DOCUMENT MANAGEMENT SYSTEMS: SHARING & COLLATION SOFTWARE
Vendors of software for document management systems and other
groupware systems often claim that their software is a collaborative
application. In reality, they are advocating sharing and collation
software. Document management systems cannot change the fact that
information is stored in files; they simply add an extra layer of
information (metadata) and provide control mechanism for accessing
these files.
To work effectively in document management systems, teams need to
break the main document into sub-documents, assigning responsibilities
to each part. Then, each author needs to lock their piece for editing
by other writers in order to avoid data loss or duplication of work.
This leads to a fragmented and serial process where contributors
constantly have to wait for each other’s input. In many cases this is
the point where project managers lose control. Towards the end of
process, the person responsible for compiling the document needs to
collate a variety of files, generate the document, and ensure that the
formatting and layout is consistent.
Truly collaborative tools, built on databases, allow for different
subchapters of a document to be created and edited in parallel. The
latest versions of all sections and subsections are always available
and accessible. Multiple writers are therefore capable of working on
the same instance of a document at the same time. This reduces
interdependence on other team members and the need for coordination
efforts.
For managers, this also ensures improved control of the document
creation process, providing access to the document as it develops.
Rather than keeping information in separate files, as isolated data
silos, document collaboration software promotes teamwork in its purest
sense, encouraging the sharing of information. As a result,
organisations can produce documentation more effectively and
efficiently, leaving time to increase output or improve quality.
As illustrated in the figure, traditional word processors and
document management systems become inadequate as the number of writers
and/or the document size increase. When two or three people collaborate
on one document, they can manage quite easily with a word processor and
a file sharing system. Conversely, small documents are easy to maintain
using groupware. But only document collaboration systems can cater to
all combinations.
MAINTAINING SEVERAL SYSTEMS IS COSTLY
Relying on one word processor as an editing environment in addition
to one or more groupware systems for access control and search not only
increases complexity from a user perspective, but also increases the
total cost of ownership (for example licensing, training and
maintenance) dramatically. The best document collaboration systems
allow organisations to manage the document lifecycle using one system.
Users can produce, store, edit, reuse and delete documents from one
common user interface.
ENSURE SUCCESSFUL IMPLEMENTATION: BELIEVE IN BAD FIRST DRAFTS
The benefits of document collaboration systems have now been
described in detail, and are summarised in Table 1. But after buying
and installing such a system, how can a company ensure successful
implementation?
From a management perspective, taking control of the document
creation process and the ability to monitor progress is ideal – nothing
can be hidden. But in organisations that migrate from traditional word
processors, writers sometimes express discomfort about sharing their
work; they may not want to share their part of the document before it
is complete.
This attitude makes it impossible for the rest of the team to
comment or monitor the progress of the document, and is a serious
threat to any collaborative document creation process. What if a
particular section is of vital importance to other parts of the
document? To ensure consistency, other writers need to have ‘read
access’. What if the writer misunderstood the brief? In this case, it
would obviously be better for everyone if they could get back on track
as soon as possible.
Be a believer in bad first drafts! Encourage the sharing of
feedback, suggestions for improvement and new ideas from day one. This
will lead to documents of higher quality, while at the same time
improving efficiency.
Table 1: Benefits of a web-native database document collaboration system
|
| |
Fact
|
Advantage
|
Benefit
|
| 1 |
Web-based |
- Work from multiple locations
- Work with partners and sub-contractors
- No local software installation
|
- No need to distribute document – can give participants access
- Always working on the latest version
|
| 2 |
Data-based |
- Several people can work simultaneously on the same instance of the document
- Automatic updating of numbering, table of contents, list of figures, tables and attachments
|
- Do not have to wait for document access
- Eliminates the time spent on checking the numbering and creating lists for font matter
|
| 3 |
Automatic layout
|
- Documents will always be identical to the corporate guidelines
- Header and footer is consistent
- Enhance corporate USPs
- Increased focus on content
|
- No time spent on formatting
- Correct use of fonts, logos and colouring
- Enhances branding
- Documents always ready in PDF, HTML, XML or RTF (Word) format
- Enhances quality of the document
|
| 4 |
Complete transparency
|
- Can track the development of the document from day one
|
- Control the process
- No surprises towards the end
- Possibility for management to give advice and guidance early on in the process
|
| 5 |
Workflow |
- Responsibility clearly defined
- Individual deadlines
- Several reviewers
|
- Participants more likely to finish work on time
- Order in the process
- All reviewers can have their say before completion of the document
|
| 6 |
Commenting tool
|
- All comments stored in one place
- Can see colleagues' comments and give comments
|
- Easy to have full overview
- Do not lose the comments
- All comments concluded
|
| 7 |
Ability to copy across database
|
- Easy to resuse information
- Automatic layout and formatting according to target template
|
- Significant time saver
- Simplifies process of using standard write-ups and the best of previous documents
|
| 8 |
Blacklining |
- Can easily track progress
- Simplifies revision gate process
- Can read changes quickly
|
- Saves time
- Increased focus on what is important
|
Reference
1. Egan D, Ghost in the Machine, BCBusiness Online, 5 August 2009, http://www.bcbusinessonline.ca/bcb/ top-stories/2009/08/05/ghostmachine# ixzz0pnFE0uvR