Building a Regulatory Information Enterprise Architecture
Next Generation User Interface in Support of Regulatory Information Management – The First
of the RIM Enterprise Architecture Series.
Selecting the right tool to replace your existing user interface and enable regulatory
transparency.
A Point of View in a series addressing the challenges of selecting enabling technologies to support RIM
TAKE Life Sciences subsidiary WCI launched the RIM Roundtable to address a number of challenges observed in the industry.
There is no universally agreed industry
definition of RIM and its scope
egulatory information is both a
R
compliance requirement and a business
opportunity
Sources and owners of Regulatory
information are extremely diverse:
Spans the entire product lifecycle
Extends beyond company boundaries
wnership of Regulatory information is
O
generally multi-functional
Regulatory information generally resides
in multiple systems
egulatory information is complex
R
– and related to a number of other
information requirements and sources,
e.g. ISO IDMP, eCTD v4.0, master data
management.
Regulatory Information Management (RIM) has become the focal point across the
life sciences industry which is driving a fundamental reassessment of processes,
systems, governance structures and ways of doing business. There are areas within
the broader scope of RIM processes that are driven by regulatory requirements
(submission management, publishing, licensing, IDMP) . There is however no
overall mandatory RIM framework, there are no guidelines and certainly no proven
path to success. Participants at our recent RIM Roundtable event articulated a
need for integrated processes, governance structures, tools and standards that
enable transparency and end to end process management across the RIM value
chain. So while there is no immediate regulatory requirement compelling change,
there is a growing view that such an integrated approach would deliver greater
compliance and efficiency which would in turn facilitate future growth.
TAKE Life Science’s subsidiary WCI queried attendees of our recent RIM Roundtable
as to what they saw were the key enablers of a RIM Solution. The list identified the
importance of governance, integration and process management. The enablers
identified were:
Clear governance & ownership of data
Integrated technology
Process standardisation
Cross functional integration & resourcing
Collaborative partnerships (MAH/Vendor)
“
RIM is the tracking of product registrations,
content and other meta - information for
regulated products in a global enterprise to
better enable decision making about product
portfolios
The codifying and maintaining of regional
regulatory knowledge in a centralised and
reproducible system
The planning of global and local regulatory
activity so as to synchronise efforts for
maximum efficiency of enterprise regulatory
resources
”
Source: DIA
As we searched the software landscape of tools that provide specific solutions
addressing RIM requirements, we found that there is not a single solution capable
of supporting end to end RIM. In fact it will require multiple solutions, many of which
have not been leveraged before in support of the regulatory function. In addition,
as we assess the current set of tools, we are finding, along with our clients, that
many of these tools do not even meet the requirements for core functionality like
Submission Management, End to End Labeling, Regulated Content Management
and Publishing etc. There are few solutions that support the need for integration,
end to end process management, and collaboration.
There is hope and that is why TAKE is launching this series of White Papers
focusing on building a logical and affordable approach for a RIM enterprise
architecture. We believe that it is possible to build a componentized approach to
RIM that will not require massive investments and will enable a loosely coupled
architecture that supports a fluid technology design allowing for legacy systems
to be leveraged until they can be replaced. It will also enable new components of
the RIM solution to be added without requiring complicated integrations and costly
implementations.
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Next Generation User Interface in Support of Regulatory Information Management
Selecting the right tool to replace your existing user interface and enable regulatory transparency.
We have purposely decided to start with the User Interface for RIM
because we see this as one of the fundamental building blocks of RIM.
This is also the area where companies can drive the biggest value
for the least cost. This point is critical, the participants in the RIM
Roundtable resoundingly expressed that a major challenge to securing
budget for RIM was the inability to identify value to the business. The
replacement of the UI rapidly provides benefit, for example;
•
educes search time for content by as much as 20% for
R
knowledge workers
•
Improves reuse of approved content shortening the time to
build and publish a submission
•
Improved user experience and adherence to process thus
reducing risk of non-compliance
•
Reduces total cost of ownership
Overall, clients that have replaced their UI with next generation
tools have identified that faster time to market, better compliance
with process, content reuse and overall user satisfaction have been
improved and goals accomplished.
Finally, we see a number of shifts in the software provider space
supporting User Interfaces for regulated content management that
make the timing good for looking at a potential change. These
changes included the shift in EMC Documentum’s strategy to move
from WebTop to D2 and develop their own solutions. This has driven
traditionally strong partners like CSC to reassess their strategy in
support of their Documentum/WebTop solution FirstDocs. EMC has
made it clear that they are going to compete with their partners utilizing
D2, leaving solutions developed on WebTop at best in a competitive
positon with EMC.
The announcement of the sunseting of EMC’s DocCompliance Manager
(DCM) has created yet another reason for reassessment. This, coupled
with entrants of new players like Veeva VAULT, Generis CARA, and the
willingness to explore open source tools like Alfresco, have many in the
industry reassessing their regulated content management tools.
The Time to Consider Replacing Your UI is NOW!
TAKE highly recommends that Clients with Custom WebTop, DCM and
FirstDocs deployments take the opportunity to explore the possibility
of replacing those user interfaces with tools that provide greater
functionality and are better suited to serve as the foundation of your
RIM Enterprise Architecture. The main reasons for making a change
now are:
1. Improved user experience
2. E nable a single user interface across
all regulatory applications, integrating
content management, publishing, shared
drives, eTMF, QMS, etc.
3. R
educed total cost of ownership and
avoidance of costly upgrade costs
4. Expanded functionality
1. Improved User Experience
One of the most common complaints in the market in regards to
regulated content management UI’s are they are difficult to use and
were not designed with the business user in mind. This impacts
adoption and overall user satisfaction. In addition it drives up training
costs and often results in users simply bypassing the system. All
of this results in a higher risk of non-compliance, less reuse, and
inefficiencies across the organization.
There are tools that enable a better user experience. For example,
Generis CARA provides a quick, ergonomic and intuitive front end
that runs in a browser but works like a standard Desktop application
(right-click menus, drag & drop, along with other features.) CARA
allows the user to filter information based on user-defined criteria and
enables different, user-specific views of information. This dramatically
increases user productivity and adoption. Reuse and access to
regulated content is facilitated via multiple views of documents:
Docbase, Structure (Virtual Document) and My-Desk including Tasks
and Favorites.
3
85% of the Participants in the RIM Roundtable are either currently replacing their WebTop, FirstDocs or DCM UI or in the process of
considering making a change in 2015
To further improve efficiency and ease of use, supporting information is
displayed in a Widgets Pane. The Widget Pane can show any number
of widgets you can build including; Locations, Related Documents,
Renditions, Task, Versions etc. Other time saving features include the
ability to login to multiple user experiences including desktop-in-abrowser, Explore, My WidgetSpace and Portal as well as the ability to
display document content and attributes with a single mouse click.
One of the key factors in selecting a replacement for your current
UI is ensuring that the new tool has a robust configuration and rules
engine. This will allow you to build different screens for the different
users / groups for the same document, including dynamic screens
not requiring re-installation, property value inheritance, automatic
numbering / naming, data dictionaries with alias values, taxonomies,
dependencies and many others. This vastly improves user adoption
and greatly reduces training time and cost. Users work with the
content that matches their business requirements.
2.Enable a single user interface across all regulatory
application integrating content management,
publishing, shared drives, eTMF, QMS, etc.
As discussed earlier, one of the key enablers of a RIM Solution is
integrated technology. The majority of our RIM Roundtable participants
expressed the greatest frustration with their regulated information
management architecture is the lack of a single UI. Double entry
and the need to log into multiple applications to complete a single
process were identified as creating increased risk of non-compliance,
inefficiency and increased training demand.
Rendering Services
DocAnnotator
Create PDF renditions
DocSecure
Watermarking, eSig
Controlled print
PDF annotations
DocPublisher
Collate multiple PDFs
With cover, TOC…
DocLink
Interpret inter-doc
hyperlinks
In the cloud
User Interface and Business Rules Layer
PLAN
CREATE
LIFECYCLE
PUBLISH
RETIRE
and mobile
Config Analyzer
Report on all aspects
of installation
BatchPorter
Batch import/export
using Excel
Migration Tools
Full migrations
There are tools that provide a single UI, tying together disparate
systems improving user adoption and making it the single point of
access portal for RIM. It is possible to have a configurable way to
modify existing functionality or create new functionality, as well as
most importantly for RIM, to build connections to other systems using
a variety of technical tools including JSP/HTML, queries, API, RESTful
Web Services, JavaScript or server methods. These connections
can then be displayed to the end user via a configured UI component
(popup, widget, screen part), with the ability to both view and update
information.
TAKE has already developed integration with Next Generation UI
platforms that integrates FirstDocs to eTMF tools like PhlexGlobal, or
Documentum and Liquent. For example, users can now push data to
Liquent’s InSight Manager when a submission is produced. Pushing
links to correspondence records to InSight and pulling data from
InSight to display in Widgets on submission-related information. This
is all accomplished without ever logging into any other UI.
3.Reduced total cost of ownership and avoidance of
costly upgrade costs
Historically switching costs were seen as one of the biggest barriers
to moving to a new UI. Our experience is that many Clients are seeing
an opportunity to reduce their total cost of ownership and spend less
on a new UI versus upgrading their legacy UI. This is accomplished
in a number of ways. For example, leveraging a tool that is purpose
built to be a business rules and process engine supports configuration
over customization. The ability to configure every aspect of the user
interface as well as build business rules such as dynamic security and
folder paths, data dictionaries and taxonomies, numbering, and more
eliminates coding. One of the most significant costs of upgrading
to FirstDocs or using WebTop is the dependency on customization
to meet the business’ requirements. These customizations can be
cumbersome to build and maintain and often need to be reworked
when new versions of Documentum are released. This not only adds
to the cost of the upgrade but to the cost of validation and testing.
Another barrier to moving to a new UI has been the concern over loss of
functionality. Clients have made significant investments in configuring
and customizing their WebTop based solutions. In addition they made
equally big investments in change manage, training and user adoption
initiatives to ensure the successful rollout of the solution. The concern
is that the investments will need to be matched if moving to a new UI.
There is a way to minimize these costs through a set of steps to help
move smoothly through the upgrade and replacement process. In
4
fact, it is possible to maintain your configurations and rules and migrate them to the new tool. With the improved capabilities of the next generation
tools the ability to build roles based screens, process flows, access levels etc. that match the way your organization works greatly reduces the change
management and training challenges and ensure rapid adoption.
TAKE have develop a comprehensive and rapid approach to assessing, piloting and implementing new UI’s. In the case of FirstDocs for example,
the replacement covers not just the Webtop UI itself but also a replacement for the FirstDoc SPX in SharePoint which can be significantly extended
to ensure no loss of functionality. The major benefit relating to SPX replacement is the removal of an additional platform in the ECM stack, which
reduces complexity, cost and integration issues.
TAKE worked with the customer to identify any customizations made to FirstDoc which need to be migrated, as well as undertaking a mapping of the
existing business rules (e.g. folder paths, security and so on). The major areas of upgrade involved are:
SPX Portal
Auditing
Replace the SPX Portal with the CARA My
WidgetSpace – avoid the need for an additional
platform with the associated costs and technical
issues
CARA provides auditing for documents and
configurations based on Categories. Use the
standard events or register custom events
Controlled Printing
Product Dictionaries
DocSecure provides the ability to create
controlled prints including watermarking with
dates, attributes and controlled print numbers
CARA dictionaries offer aliasing, abbreviations
and multi-lingual capabilities. Cabinets can be
displayed based on product name, number or
generic name
Purging & Retention
Notifications
Rules for purging and retention can be configured
in CARA based on Categories, including Legal
Hold options. Also can be used with EMC RPS
module
Templates for notifications are fully configurable as
to content, language, links, attribute replacement,
logos, HTML and more
Workflows
Lifecycles
FirstDoc BPM workflows are replaced with out of
the box BPM workflows or the CARA workflows
which offers the ability to configure in-app
Custom FirstDoc lifecycle functionality will be
replaced by standard Documentum Lifecycles,
allowing easier third party tool integration
Watermarking
Integrations
DocSecure
provides
industry-strength
watermarking and signature page manifestation,
with configurations to replace built-in FirstDoc
integrations
CARA offers integration with not only publishing
tools (ISI, Liquent, DocPublisher) but also other
systems such as CTMS, registration tracking
and more
GxP / R&D / eTMF
CARA contains all the configuration to replace all
separate FirstDoc modules – no longer requiring
separate licensing and functionality
5
Processes that are deemed non-core competencies are being routinely outsourced to external partners as companies seek near term cost savings
and / or process agility. Externalisation of non-core competencies is now the norm and preferred partnership arrangements are redefining what was
historically called the FIPNET model [the Fully Integrated Pharmaceutical Network]. At the same time, the boundaries of the life science ecosystem
are expanding and collaborations and partnerships have grown to include academic medical centers, healthcare providers, and healthcare payers
under the umbrella of translational research / medicine.
- Alan S Louie, Research Director, Health Industry Insights, IDC Company, USA
4. Expanded functionality
The RIM Roundtable Participants identified the need for expanded
functionality of their UI as a critical enabler for their RIM solutions.
The legacy UIs like FirstDocs and DCM provide functionality that is
specifically focused on managing regulated content. They do not
address the key enablers identified in the RIM Roundtable
•
Clear governance and ownership of data
•
Technology Integration
•
Process Standardization
•
Cross functional integration & resourcing
•
Collaborative partnerships (MAH/Vendor)
Another frequent requirement is the need to put content from the
repositories through a third party system for purposes such as review,
publishing and so on, using tools which may or may not communicate
natively with the content management systems. The Next generation
UI provides the solution to this through its Custom Actions as part of its
Hub for each integration and customization.
Simply define the communication method (e.g RESTful web services
or invoking the third party UI through a built-in pop-up or framed JSP/
HTML page,) and define how and when that screen is invoked (menus,
buttons, under what conditions e.g. group membership, document
properties and more.) By directly invoking all or part of the UI of the
third party too, you avoid recreating those features. Or, use JSP or
Is your current UI capable of acting as the Hub for all regulated data?
The next generation UI must accommodate these requirements and
facilitate the concept of a “Hub” for all regulatory data, process, and
reporting. The Legacy tools were not developed to accommodate the
integration beyond Documentum
Integrating applications has become a lot simpler as a back end
function since the advent of more open standards of communication
including Web Services. However, the difficulty arises in creating
customized front-ends to display integrated information.
Examples of such integrations might be the requirement to fetch
and display data from an external system that relates to a selected
document in Documentum, e.g. Supplier name, address, phone and
email from a supplier database based on an attribute of “supplier
number” on the Documentum – or clinical information from a CTMS
system based on study number.
ExtJS / ExtGWT to build your own UI component that will interface with
the system using Web Services.
Using this ability User Interface tools can be integrated with multiple
tools already, each integration taking between a few hours and 1-2
days, instead of the normal UI-level integration effort of multiple
weeks, including
•
•
•
•
•
•
•
•
Brava
ViewONE Pro
SharePoint
Elementool
Siebel CTMS
PleaseReview
Liquent LES
Extedo
6
“The May meeting was certainly one of the best regulatory events I've attended… we will be happy to send a participant to any other
roundtable events you host”
- RIM RT Attendee (Spring 2014)
The need for process standardization, Cross functional integration and
resourcing and the ability to enable collaborative partnerships, both
MAH and Vendor, must be supported by the UI Hub. With the advent of
new business concepts like a Fully Integrated Pharmaceutical Network
(FIPNet) and the push for more outsourcing there is a growing need of
enterprises to increase flexibility with respect to changes in their own
business processes and the ways in which they interact with partner
companies.
Conclusion: The Time is Now to Move to a Next Generation UI
Traditionally, business processes have been designed within the
boundaries of an enterprise, or even within the different business
units of the enterprise. These activities were managed with the help
of detailed, real-time information. A RIM Solution demands that
processes span multiple business units or enterprises typically with a
very different set of requirements, needing a higher degree of flexibility.
Because RIM is evolving and there are few standards or common
technologies across the industry, one sees a much higher degree of
uncertainty, a much more frequent change in terms of participants and
their roles, a constant evolution of the types of interactions required
and a need to accommodate changing systems.
The market is moving quickly to address the broadening requirements
of RIM. The Next Generation UI is a critical enabling technology
that will provide the foundation of a loosely coupled RIM Enterprise
Architecture. It can support:
•
Faster time to submission
•
Rapid deployment and user adoption
•
Integration across the RIM Enterprise Architecture
•
A Single User Interface
•
Great reuse
•
Process adherence
•
Improved compliance
TAKE Life Science is at the forefront of RIM and can provide a broad
set of services including:
•
Strategy & Change Management
•
Technology Assessment
•
Implementation Services
•
Regulatory Outsourcing Services
The next generation UI must be capable of handling these types of
"in-flux" situations and support a loosely coupled architecture. This
will replace the overall complexity and dependencies of point to
point integrations. Using a UI that enables loose coupling makes
the application landscape more agile, enables quicker change, and
reduces risk. In addition, system maintenance becomes much easier.
Loose coupling is essential to the FIPNet and outsourcing model,
where business entities must be able to interact independently. The
relationships between business partners often change rapidly—
alliances are settled and cancelled, and business processes between
trading partners are adapted to new market requirements.
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