governance processes service_types_for_opx2_jak1c1

Governance, Processes, and Service Categories

for OPX2

Planisware Global Paris OPX2 User Conference 200725-26 October

John Andrew KosseyMerck and Co., Inc.

MRL ITResearch Information Services

Research Planning and IntegrationOPX2 Operations

North Wales, Pennsylvania 19454United States of America

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Key Topics in Presentation1. OPX2 at Merck Research Laboratories

(MRL)2. Why governance, processes, and service

“categories” are key drivers of OPX2 business value• Governance and OPX2• OPX2 and service-implementation processes• Evidence-based OPX2 service classification

3. Bonus discussion--as time allows• How “software evolution” applies to OPX2• OPX2 version-release management

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Merck Overview

Merck is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs.

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Putting Patients First

“We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear.” - George W. Merck, 1950

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Merck’s Guiding Principles

• Pursuit of scientific excellence

• Dedicated to putting patients first

• Committed to the highest standards of ethics and integrity

• Contributing to our neighbors, employees, and communities where we live and work

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About Our PastMerck is founded in New York City by George Merck

18911902

Established manufacturing facility

in Rahway, New Jersey

1912

Opened first foreign

subsidiary in Canada

1930s19191916

The first Merck research laboratory is established in Rahway, New Jersey

Separated from German parent

Established framework for cooperation between business and universities on scientific research

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About Our Past

19441940s

195319571992Merck moved headquarters to Whitehouse Station, New Jersey

Pioneered with other labs to speed full-scale development and production of penicillin during World

War II Merck made its first donation to the United Negro College Fund

Merger with Sharp & Dohme

The Merck Company Foundation established

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Current Facts About Merck

• 60,000 employees worldwide• Conducts research in a number of

different therapeutic areas• Markets products in approximately

200 countries and regions• Invested more than $4 billion last

year in research & development

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At Merck, Scientific Excellence Is the Focus and Passion that Drives Everything We Do

Merck research is dedicated to the discovery and development of innovative medicines and vaccines that create new medical breakthroughs.

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Remember Measles? Mumps? Rubella?Merck Research Means Your Kids Probably Won’t

Today Merck is one of the few drug companies still conducting vaccine research to combat childhood diseases. Merck vaccines have

helped combat diseases like measles, mumps, rubella, chickenpox and, most recently, rotavirus.

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We Also Know the Value of Unbiased General Health Information

MerckSource.com provides you FREE, unbiased health information on an easy-to-use web site with no advertising

The Merck Manual, the world’s best-selling medical references, available free online in multiple languages at www.merck.com

The Merck Manual for FreeHealth Questions? Go right to the Source

http://www.merck.com/

http://mercksource.com/pp/us/cns/cns_home.jsp

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Examples of Past and Present Areas of Research

Alzheimer’s DiseaseAnti-infectivesAsthmaCancerChemotherapy-Induced Nausea

and Vomiting (CINV)ChickenpoxDiabetesGlaucomaHeartburnHepatitis A&BHigh Blood PressureHigh Cholesterol

HIV/AIDS InfectionHuman Papillomarvirus (HPV)MeaslesMigraine PainMultiple SclerosisMumpsObesityPainParkinson’s DiseasePostmenopausal OsteoporosisPsychiatric DiseaseRotavirusRubellaSeasonal AllergiesShinglesSleep DisordersUrinary Incontinence

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MRL Research Locations—over 7,800 Employees Worldwide

AsiaTokyo, JapanTsukubaMenumaOkazaki

EuropeHoddesdon, Herts, UKPmezia, ItalyMadrid, SpainRiom, France

CanadaMontreal, Quebec

United States of AmericaRahway, New JerseyWest Point, PennsylvaniaBoston, MassachusettsSeattle, WashingtonSan Francisco, CaliforniaBoulder, Colorado

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Key Topics in Presentation1. OPX2 at Merck Research

Laboratories (MRL)

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OPX2 at MRLMerck Research Laboratories

Operational as Pro client since 30 August 2002Capacity planning and management of research

pipeline projects was initial functionExtended from clinical and regulatory to include

pre-clinical development in 2003Detailed scheduling for clinical data management,

safety assessment have separate schemasServes approximately 1,300 unique users

throughout the division; all are on R4

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Key OPX2 Stakeholders• Research Planning & Integration• Resource & Decision Management• Major oversight committees• MRL functional areas• Project managers• HR/Finance/IT• WCDMO, Safety Assessment (detailed

scheduling)• Banyu (Japan)

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Key Processes that OPX2 Enables (1)• Optimizes resource capacity and portfolio

analyses• Provides multi-year view of current research

pipeline, desired future pipeline• Provides franchise support to identify optimal

strategic business decisions• Feeds Process and Technology Integration (PTI)

process for CLPA data warehouse

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Key Processes that OPX2 Enables (2)• Updates MRL “book of business”• Early Stage Franchise & Functional Area

Support• Late Stage Franchise & Functional Area Support• Skill sets for GTMS time tracking• Banyu capacity management

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Current Operational Challenges with OPX2 at Merck MRL• Processes and Service Level Agreements are in

early stages of development • Excluding Oracle, infrastructure, vendor

components, M&O has grown from one FTE in 4Q 2002 to more than 4.5 FTE in 2Q 2007

• Individual workload often exceeds 50-60 hours per week

• Demand for new business enhancements outstrips IT funding and capacity to develop

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Keeping up with Current OPX2 Requests . . .

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(MRL)2. Why governance, processes, and

service “categories” are key drivers of OPX2 business value

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service “categories” are key drivers of OPX2 business value• Governance and OPX2

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Context for OPX2 in an Organization

Governance—Who determines?

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OPX2 Governance

1. Decides or arbitrates deadlocks?

2. Defines area-wide/corporate business rules, e.g., “What constitutes a project?” “Who has stewardship for each data element?”

3. Controls funding?4. Manages software?

Who

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“Home” Models for OPX2 Company Support and Development

Business Unit (dedicated team)

IT Unit (team has OPX2

duties)•Shared IT Maintenance and Operations with Outsourced Components

•Shared IT Development with Outsourcing/Off-shoring

Contracted outside Company in Long-term Off-shoring Strategy

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Equal PartnershipBusiness-IT Model

Requirem

ents

Performance

metrics

Business Unit

IT Unit

Service Level Agreement (SLA)

WHY—business caseWHAT—processes, dataWHEN—business priority

HOW—technologyWHO—tech resourcesWHEN—IT priority

Collaborate,Negotiate

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service “categories” are key drivers of OPX2 business value• Governance and OPX2• OPX2 and service-implementation

processes

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Processes—How managed?

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10 Basic ITIL Processes

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Key Process Areas for Software Maintenance and Evolution [A. April et al. 2005]

Primary Processes1. Pre-delivery and initial deployment2. Event and service request management3. Operational support4. Corrections5. Evolutions6. Changes monitoring7. Software rejuvenation, migration, retirement

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Support Processes1.Documentation2.Configuration and version management3.Process, service quality assurance4.Verification, validation5.Reviews, audits6.Causal analysis and problem management7.Application administration—OPX2

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Organizational Processes1.Maintenance planning2.Measurement and analysis of maintenance3.Innovation and deployment4.Corrections5.Process definition, assessment, improvement6.Human resources capacity and training7.Purchasing, vendor agreement, SLA

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Software Maintenance Maturity Model* [A. April et al. 2005]

Levels1.Performed2.Managed3.Established4.Predictable5.Optimizing

DescriptionAd hoc maintenanceRepeatable request-based processState-of-the-art maintenance processOngoing process improvementInteractively informs SLA; automatic metrics generation with drilldown

*Competitive industry pressures demand greater process maturity than “Lone Ranger” individual effort. Processes need definition and repeatability at minimum.

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service “categories” are key drivers of OPX2 business value• Governance and OPX2• OPX2 and service-implementation

processes• Evidence-based OPX2 service

classification3.

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Processes—How managed?

What changed in

OPX2?

Documentation

Support Interface

Data

Business Rules,

Elements

OPX2 SystemProperties

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Basis for Defining Software Maintenance and Evolution [N. Chapin et al. 2001]

• Activity–what function are/were you doing?• Intention—what is/was the intention driving

your work?• Evidence--comparing before and after states,

what changed?

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Benefits of Evidenced-Based Classification [N. Chapin et al. 2001]

• Comparison of before and after states is fairly consistent and objective

• Does not depend upon recollections, notes from developers and support people

• Avoids “politically correct” bias in making classifications

• Readily extendible to configurable software such as OPX2

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OPX2 Change “Categories” (Domains; Clusters)

What changed in or with OPX2?

Documentation

Support Interface

Data

Business Rules,

Elements

OPX2 SystemProperties

1

2

3

4

5

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1. Support Interface CategoryWas OPX2 changed? NO

• Was OPX2 basis for training? Training• Was OPX2 basis for consulting? Consultive• Was OPX2 basis for study? Evaluative*• Was OPX2 user issue reproduced? Reproduced

*Default category for cluster

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2. Documentation CategoryWas OPX2 environment or software changed? NO

• Was existing documentation repurposed? Reformed

• Was documentation conformed to current OPX2 environment or software? Updated*

• Was one or more future-state OPX2 business requirements defined or refined? Creative


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3. Data CategoryWas OPX2 environment or software changed? NO

• Was OPX2 data deleted? Removed• Was OPX2 data changed? Revised*• Was OPX2 data added? Added

– Example: Adding resource to resource breakdown structure

• Was OPX2 data processed? Processed– Example: Running update macro across projects– Example: Batch processing algorithms


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4. OPX2 System Properties CategoryWas OPX2 environment or software changed? YES

• Was OPX2 software, environment duplicated? Spawned• Did change make system more maintainable? Primed• Did change avoid future maintenance? Preventive• Did change alter system performance? Performance• Did change adapt system to external requirements?

Adaptive*• Did OPX2 user account change? Access• Did Planisware update or software version fix bug?

Fixed


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5. Business Rules, Elements CategoryDid OPX2 environment and business rules, elements change? YES• Did new requirement result in a working design?

Prototype• Did environment object support specific, evolving

business rule, element need? Tailored• Was business rule, element reduced or removed?

Reductive• Was business rule, element corrected or fixed?

Corrective• Was business rule, element enhanced, added,

superseded? Enhanced*


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Types of Change in OPX2 for Maintenance and Evolution Services (1)

Type of Change ClusterAccess 4. OPX2 System PropertiesAdaptive* 4. OPX2 System Properties

Added 3. DataConsultive 1. Support InterfaceCorrective 5. Business Rules, ElementsCreative 2. DocumentationEnhanced* 5. Business Rules, Elements

Evaluative* 1. Support Interface

Fixed 4. OPX2 System PropertiesPerformance 4. OPX2 System PropertiesPreventive 4. OPX2 System PropertiesPrimed 4. OPX2 System Properties

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Types of Change in OPX2 for Maintenance and Evolution Services (2)

Type of Change ClusterProcessed 3. Data

Prototype 5. Business Rules, Elements

Reductive 5. Business Rules, Elements

Reformed 2. Documentation

Removed 3. Data

Reproduced 1. Support Interface

Revised* 3. Data

Spawned 4. OPX2 System Properties

Tailored 5. Business Rules, Elements

Training 1. Support Interface

Updated* 2. Documentation

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Benefits of Categorizing Software Maintenance and Evolution Services• Clarifies nature of services needed for

OPX2• Enables concrete service comparisons • Details short-term, long-term trends• Provides basis for cost analysis• Supplies meaningful categories for

process definitions• Communicates granularity of work effort

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(MRL)2. Why governance, processes, and service


3. Bonus discussion--as time allows• How “software evolution” applies to

OPX2

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Merck's Systems Life Cycle (SLC)

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Assumptions• Development—Concept,

Specification, Construction—occurs before Installation

• Maintenance is part of Operation• Little or no role for post-Installation

development efforts

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OPX2 Post Deployment: Annual change in number of environment objects

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OPX2 Operations Phase Has Two Stages

• Active evolution--adding new capabilities • Maintenance servicing--customers no longer

need/seek new functionality

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Simple Staged Model of IT Maintenance and Evolution [Bennett and Rajlich 2000]

• Initial development—first running version developed and deployed

• Evolution—adapts application to ever-changing business requirements after first version deploys

• Servicing—application no longer evolves; maintenance/servicing only

• Phase-out—servicing discontinues; migration?• Close-down—full retirement

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Key Topics in Presentation1. OPX2 at Merck Research Laboratories (MRL)2. Why governance, processes, and service


3. Bonus discussion--as time allows• How “software evolution” applies to OPX2• OPX2 version-release management

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OPX2 Version Release Categories

• Operational—daily– Corrective; Fixed; Revised; Adaptive; Access;

Spawned; Preventive; Primed; Tailored• Business—monthly

– algorithm updates; Tailored; Reductive• IT bundle—quarterly

– Enhanced; Performance • Initiative—special

– major Enhanced; Adaptive;

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