2008 by Virtify, Inc. All Rights Reserved.

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Process Improvement











Process Assessment and Improvement Approach

June 2008














The information contained in this document represents the current view of Virtify on the issues
discussed as of the date of publication. Virtify cannot guarantee the accuracy of any information
presented after the date of publication. This document is for informational purposes only. Virtify
makes no warranties, express or implied, as to the information in this document.

Complying with all applicable copyright laws is the responsibility of the user. Virtify may have
patents, patent applications, trademarks, copyrights, or other intellectual property rights
covering subject matter in this document. Except as expressly provided in any written license
agreement from Virtify, the furnishing of this document does not give you any license to these
patents, trademarks, copyrights, or other intellectual property.




2008 by Virtify, Inc. All Rights Reserved.
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Process Improvement
1. Background
Business operations managers constantly need to assess, fine tune and optimize
their organizational processes with an eye towards streamlined operations. The
challenge lies in balancing these process improvements while minimally
disrupting day-to-day operations. Further, the process optimization need to
account for rapidly changing business needs, current and upcoming regulatory
changes (e.g., eCTD, Structured Product Labeling, eStability etc.), evolving
technology and infrastructure. In addition, involvement and continuous
engagement of key stakeholders is often a key challenge. We recommend a
phased process assessment and improvement methodology that offers a
comprehensive review and assessment of the efficiency and effectiveness of the
organizations current processes and results in practical recommendations for
quick-hit and long-term strategic process improvements to suit specific
organizational needs. Such improvements can result in more streamlined
processes that provide better predictability and consistency in operational
results, improved control over both the process and associated costs, and finally,
a deeper insight into the strategic value of process improvement.
2. Process Assessment and Improvement Methodology
Virtify uses a structured process assessment and improvement methodology to
enable organization to streamline their operations. This methodology is:
A quality-driven process based on an integrated set of deliverables
that build on each other incrementally to deliver solutions quickly. It
is flexible enough to consider each clients specifics without sacrificing
a rigorous quality framework.
Based on the notion that a process is the collection of activities that
transform inputs into outputs to achieve organizational objectives.
Based on the recognition that there are two types of processes: core
processes that deliver value directly to key customers or stakeholders,
and support processes that support the core processes.
Focused on the key components of assessing and improving a
process, namely Define, Measure, Analyze, Improve and Control.
These components and their interconnections are shown in Figure 1,
and form the core of the phased project approach outlined below.





2008 by Virtify, Inc. All Rights Reserved.
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Process Improvement
2.1 Process Assessment and Improvement Steps
Essential elements of the Process Assessment and Improvement include the
following steps:
1. DEFINE: This step involves defining the problem (or area of focus),
articulating the current process, and identifying key stakeholders
involved in the process.
2. MEASURE: In this step, we identify what is being measured and a key
element of this step is the identification of the appropriate benchmarks
(industry and other internal/external benchmarks) against which the
process is being compared.
3. ANALYZE: The next step involves analysis of the process under
consideration for root cause or trend analysis.
4. IMPROVE: Upon completion of the analysis of the process, the next
step is to a) identify solutions that enable process improvement and b)
establish criteria for testing the solution. In addition, another key
element of this step is the definition of the roadmap for implementing
the identified solution.
5. CONTROL: This step focuses on establishing the appropriate
mechanisms to ensure a successful implementation of the improved
process. Elements include (re) training, documentation, continuous
testing, expectation/communication management and rollout to the
organization.

Once these process improvement steps have been completed, we recommend
continuous monitoring and calibration against benchmarks to ensure ongoing
fine tuning and periodic improvements. Essentially, the lifecycle of the steps
listed above should be repeated as and when appropriate and necessary.
2.2 Implementation Approach
The process assessment and improvement methodology listed in Section 2.1 can
be implemented within a broader, phased approach consisting of the
Requirements Gathering, Process Mapping, Process Analysis, Process Redesign,
and Roadmap Generation phases will be used within a structured project
management framework to develop the project deliverables. Such a phased
approach, including the use of the process assessment components outlined in
Figure 1, is illustrated below in Figure 2.




2008 by Virtify, Inc. All Rights Reserved.
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Process Improvement




















Figure 1: The various components of process assessment and improvement
are shown in this figure. The assessment begins with a Define phase focusing
on the people, problem and process, followed by a Measure phase that
examines the various steps in the process and related measurement criteria.
The Measure phase is followed by the Analyze phase that aims to come up
with gaps in the current process and the root cause for the gaps. The Improve
phase identifies the redesigned process and its implementation criteria,
followed by a Control phase for continuous monitoring and management of
the redesigned process. These components are used iteratively.


[Rest of page left intentionally blank.]





DEFINE
What is the
problem?
What is the process?
What is the focus?
Who are the key
customers and
stakeholders?
MEASURE
What are the steps
of the process?
What will be
measured?
What is the target
with respect to
process
effectiveness,
process efficiency
and process
adaptability?
ANALYZE
What patterns or
trends emerge?
What is the
potential root cause?

IMPROVE
What is the best
solution?
How should it be
tested?
How should it be
implemented?
CONTROL
Are people
prepared and is the
documentation
complete?
Are measures
identified and is
there an ongoing
monitoring process?
Has the process
been error-proofed?
Start




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Process Improvement








Figure 2: This figure illustrates the various phases of Virtifys methodology
for process improvement. The accompanying components of process
assessment are overlaid (in italics) on the various phases of the project.

In the context of this phased approach for process assessment and
improvement, we recommend a team consisting of relevant domain experts,
along with key organization stakeholders, to work in a tightly integrated
project team to:
1. Conduct a project kickoff meeting for project planning, scheduling
and identifying administrative issues.
2. Generate business requirements using facilitated workshop and
interview sessions with representative cross-functional end user
groups. We recommend a series of facilitated discussions with
relevant cross-functional end user groups to obtain this
information. These discussions should be staggered to allow for the
most efficient use of time and reduce the amount of follow-up
effort. Often, it may be necessary to meet with organization
personnel outside of the core groups to gather the data required.
The sessions should focus on gathering information about the
current process, systems and applications, flow of data/content,
immediate and long-term use of the data, and impact on relevant
organizational operations. The information gathered from this
phase should be used to perform the process assessment, estimate
organizational impacts and to build the roadmap in subsequent
phases of the project.
3. Identify and map the business process flows of the current
document creation, document storage, submission preparation,
assembly and publication processes. These business process flows
include responsible individuals or organizations, relevant SOPs,
Requirements
Gathering
Current
Process
Mapping
Current
Process
Analysis
Process
Redesign
Roadmap
Generation
Imple-
mentation
Define Measure
Analyze
Improve
Define
Control




2008 by Virtify, Inc. All Rights Reserved.
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Process Improvement
templates and tools used, and metrics. The relationships between
people, functions and process steps should be illustrated via cross-
functional process maps.
4. Perform a current process assessment and gap analysis based on
the prioritized business requirements and the process maps
generated in the previous phase. Current and desired measures for
various aspects of the process (e.g., number of review cycles of the
content, time taken to format and assemble the submission, quality
of the content etc.) should be used in assessing the deficiencies of
the current process and identifying target performance goals.
5. Develop a redesigned process to address process gaps and enable
optimal future document creation, document storage, submission
preparation, assembly and publication processes. During the
redesign phase, specific attention will be paid to factors related to
the improved process (e.g., assembling an electronic submission,
the structure, including electronic review aids, of the application,
file naming conventions, generation of XML backbones, and related
eCTD factors. Global regulatory requirements for paper
submissions (e.g., in the EU) should also be taken into account
during the redesign phase.) In addition, a high-level organizational
impact assessment of the proposed solution should be performed,
including roles and responsibilities of the organizations and
functions involved in the solution, business process changes
necessitated by the proposed solution, and impact of business
process changes on available personnel and responsibilities.
6. Finalize a roadmap for the process improvement. The roadmap
should include all tasks, estimated durations, responsible
individuals and skill sets for implementing the recommendations.

We recommend the following deliverables be developed as part of the
project:
1. Detailed business process flows (e.g., current document creation,
document storage, submission preparation, assembly and
publication processes). These business process flows should
include responsible individuals or organizations, relevant SOPs,
tools used, and metrics. The areas of risk should also be identified
in these process flows.




2008 by Virtify, Inc. All Rights Reserved.
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Process Improvement
2. A detailed roadmap for moving organizations business processes
to support the new process (e.g., eCTD-based submissions). This
roadmap should include all strategic and tactical aspects of
implementing the required business processes. The roadmap
should also include all tasks, estimated durations, responsible
individuals and skill sets.
3. Critical Success Factors and Common Pitfalls
The following critical success factors will enable a successful application of the
proposed approach and methodology towards streamlining operations.
Common pitfalls of traditional process assessments exercises are also included in
the following subsections.
3.1 Value Driven
A key critical success factor is a clear, documented understanding of the
business requirements that drive the process being assessed. All
technology decisions related to the process, should be made based on the
business requirements. The intent is not to implement technology for
technologys sake. The project approach and methodology are structured
to understand the relationships between market factors, business
strategies, performance measures, workflows, and enabling technologies.
These relationships rank the business initiatives and develop the
implementation roadmap.
3.2 Cross-functional Teams and Common Understanding of Goals
Virtify defines the cross-functional team as a group with even
representation from the business, user, and technical communities. Team
members must be dedicated to the project, have a common understanding
of the goals of the project, be empowered to make decisions, and be
involved for the duration of the project to maximize the effectiveness of
the cross-functional team. Timely access to an appropriate cross-functional
team is a key success factor.
3.3 Managing the Scope of Process Mapping
The purpose of process mapping is to develop a common understanding
of the business requirements impacting the process. Many process
assessment projects get derailed due to the analysis-paralysis syndrome




2008 by Virtify, Inc. All Rights Reserved.
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Process Improvement
and inordinate documentation of exceptions to the general process. It is
critical to monitor the process mapping exercise to ensure that this pitfall
is avoided. Thus, effective management of scope is a critical success factor.
3.4 Communication and Expectation Management
Another key critical success factor in the successful implementation of the
project is the clear communication of project roles, goals and expectations
to the appropriate stakeholders and affiliated personnel. It is important to
work with relevant internal and external organizations to establish
appropriate communication mechanisms and to ensure that the
appropriate expectations are set proactively.
3.5 Integrated Project Management and Proactive Risk Management
Project management is the application of knowledge, skills, tools, and
techniques to project activities in order to meet or exceed stakeholder
expectations. The focus of project management is on getting people to
complete a series of tasks aimed at a final deliverable, through:
A high degree of review.
The establishment of a project culture that enforces an
environment of raising and escalating issues as early as possible.
The ability to effectively manage issues and change as the project
progresses.

We recommend employing proven, disciplined methodology and best
practices around project management, based on an experienced staff that
has developed and refined these practices over many years and complex
projects. Such a project management methodology allows for closely
tracking and managing the cost, scope and schedule of the project. In
addition, process rigor and discipline within the methodology ensure the
delivery of high quality results on time and within budget. For example,
Virtify works closely with the relevant Organization stakeholders to
develop and manage communication, risk, project controls, and best
practices. The key project management phases, with project
communication being a vital component of all the phases, include:
Cost and Schedule Tracking and Management: Throughout the
lifecycle of a project, Virtifys approach ensures close tracking and




2008 by Virtify, Inc. All Rights Reserved.
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Process Improvement
management of project costs and timelines, via detailed planning,
use of tools such as Microsoft Project, and continuous assessment
and monitoring against established metrics. Key deliverables from
these activities include a project plan, with associated project
deliverable milestones, resource usage and schedule details.
Documentation: All relevant project documents and deliverables
are developed and maintained per industry standards and other
relevant guidelines and requirements.
Integrated Quality Assurance, Risk Management and
Reporting: Quality control and assurance practices are integrated
throughout our approach. Examples of such practices include early
agreement on Acceptance Criteria. In addition, risk assessment and
control practices are included right from the planning stage
through the execution and closeout of the project. Key to these
practices is the proactive identification, communication, analysis
and tracking of risks throughout the project. Also, risk control is an
important activity once risks have been identified. The deliverables
from this phase include a plan to mitigate cost, schedule and
deliverable risk based on the acceptance criteria, as well as project
performance reports.
4. Conclusions
We recommend a practical approach that emphasizes a phased approach to
process definition, assessment and improvement. Key success factors in
implementing process improvement activities include the pro-active
involvement of all stakeholders throughout the exercise. It is vital to establish
appropriate benchmarks for achieving the optimal improved process. The
benchmarking exercise will also allow the selection of specific processes based on
their predicted business benefit rather than attempting a huge process change. In
addition, it is important to define key metrics to monitor the progress of the
improved process. Finally, we recommend continuous training and education as
elements of rolling out the improved processes.