A.) OPERATIONAL EXCELLENCE (OPEX)

Drive Human & Organizational Performance (HOP) Initiatives

Streamline and Automate Processes & Operations

Drive Adoption through Improved User Experiences

Develop Insight & Control through Active Monitoring & Metrics

Develop Improved Track & Trace Capabilities

Review, Refine & Develop Training Programs

B.) OPEX TOOLS & TECHNIQUES

Map Current Processes

Identify Weak & Inefficient Processes, including through Gemba/Genba

Re-engineer Business Processes (BPR/BPRE)

Design, Map & Implement New Processes

Determine Process, System & Data Relationships

Map Value Chains

Develop Value-Stream Mappings of Material Flows & Information Flows

Summarize relevant Suppliers, Inputs, Processes, Outputs, and Customers (SIPOC, also referred to as COPIS)

Develop SWOT (Strengths, Weaknesses, Opportunities, Threats)

Develop a Balanced Scorecard

Enable Modeling & What-If Analyses

C.) QUALITY MANAGEMENT SYSTEM Documentation

Write from Scratch or Revise:

• Policies, Manuals & Objectives

• Standard Operating Procedures (SOP)

• Work Instructions (WRK)

• Job Breakdown Sheets (JBS) based on Training Within Industry (TWI) Methodology

• Job Aids & Enabling Documents

Ensure Alignment Within & Across Processes as well as with Training Programs

D.) Health & safety

Identify Requirements for:

• Safety Training Programs

• Facilities & Safety Equipment

Implement:

• Safety Response Programs

• Documentation to Identify & Communicate Safety Hazards and Emergency Procedures, including First Aid

E.) compliance & TRAINING

Aim to Conform with Agency Guidelines while Properly Managing Specific Types of Product or Process Information in Association with:

• Current Good Manufacturing Practice (GMP)

• Current Good Laboratory Practice (GLP)

• Current Good Clinical Practice (GCP)

• Good Regulatory Practice (GRP)

• Good Distribution Practice (GDP)

• Good Agricultural Practice (GAP)

Develop & Implement Blended Training/Learning Programs:

• Instructor-led

• eLearning

• Simulations

• Shadowing & Hands-on

• Coaching & Mentoring

• Case Studies

Enforce Operating Standards, such as:

• Medical Device Regulation (MDR)

• General Data Protection Regulation (GDPR)

• Identification of Medicinal Product (IDMP)

F.) METHODS, FORMATS & STANDARDS

Six Sigma & Lean Six Sigma, including:

• DMAIC

• DMADV

• Root Cause Analysis (The 5 Whys)

Japanese Methodologies:

• Hoshin Kanri

• Kaizen

• The 3 Mu

• The 5S Movement

• The 7M Checklist

• The 7 Muda

• Just In Time (JIT)

• Kanban

• Gemba/Genba

Change Management:

• Prosci ADKAR: Awareness, Desire, Knowledge, Ability, Reinforcement

• Plan-Do-Check-Act (PDCA)

• Kotter 8-Step Change Model

A.) AUTHORING & TECHNICAL SOLUTIONS

Technical Authoring / Technical Documentation

Technical Drawing / Illustration & Computer-Aided Design (CAD)

3D Animation, 3D Modeling, 3D Simulation & Rendering

Video Production & Still Shot Photography

Content Strategy & Content Management

Structured Data Development & Management using XML & DITA

Training Program & Material Development

B.) DOCUMENTATION TYPES

ISO 9001-Related Documents:

• Policies, Manuals & Objectives

• Standard Operating Procedures (SOP)

• Work Instructions (WRK)

• Job Breakdown Sheets (JBS)

• Job Aids & Enabling Documents, such as Records & Forms

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Other Document Types JANA Produces:

• Process Flow Diagrams (PFD)

• Piping & Instrumentation Diagrams (P&ID)

• Wiring Diagrams & Schematics

• Illustrated Parts Lists & Catalogues

• Product Illustrations & Detailed Breakdowns

• Tool, Equipment & Instrument Manuals

• Installation, Operation, User & Procedural Manuals

• Maintenance & Repair Manuals

• Fault Isolation Manuals

• Safety Manuals & Safety Training Materials

• Data Sheets, Spec Sheets, Material Safety Data Sheets (MSDS) & Safety Data Sheets (SDS)

• Style Sheets

• Service Bulletins

• Compliance Guidelines (e.g., OSHA)

C.) DATA & DOCUMENT MANAGEMENT

Develop Data & Document Management Strategies

Identify Core Data & Documents and their Respective Systems

Develop, Deliver & Manage Structured Data in XLM & DITA

• Build Taxonomies

• Add Enrichment & Metadata

• Optimize Content Reuse

• Validate Data & Documents

• Facilitate & Accelerate Content Development

• Create Dynamic Learning Materials

• Develop Real-time Marketing Literature

• Enable Efficient Content Use & Reuse: Write Once & Publish Everywhere

• Reduce Redundancies

• Improve Search Experiences

• Enable Transparency to Regulators & Partners

• Enhance Customer Support: Target Content Based on Their Profiles

• Ensure Customers Get the Latest Information

Facilitate Selection of Data & Document Systems

Manage Conversions of Documents from Legacy Software (e.g., FrameMaker and Interleaf) into DITA

Manage Migrations & Integrations of Critical Business Information, including Regulated Content

Validate and Implement Systems (Refer to IT Systems)

D.) METHODS, FORMATS & Standards

Simplified Technical English (STE)

Document Type Definition (DTD)

Extensible Markup Language ( XML)

Standard Generalized Markup Language (SGML)

SGML-Family Markup Language (GML, SGML, XML, HTML)

Formatting Output Specification Instance (FOSI)

DocBook in support of Presentation-Neutral Form

Structured Product Labeling (SPL)

Regulatory: FDA, EU, OSHA, GDPR & IDMP

A.) SYSTEM CHECKUPs & ROADMAPPING

Map Current & Future State Processes & Systems and Develop Associated Transition Plans

Articulate Data Flows & Connections and Develop Information Architecture

Develop Requirements & Selection Criteria for:

• Data Services & Business Intelligence (BI)

• Software Products & Operating Capabilities

• Content Types & Data Size Requirements

• Storage Capacities & Locations

• Web, Cloud & Mobile Capabilities

Assess, Design, Develop & Maintain Intranet & Internet Websites

B.) MIGRATE, INTEGRATE, STRUCTURE & STORE

Migrate Data, Documents & Systems:

• Extract, Transform & Load (ETL) Data

Integrate Databases:

• Establish Application Programming Interfaces (API)

Organize & Structure Data:

• Separate by Strategic Business Units (SBU)

• Develop Master Data Layers

• Enable Rigorous Data Analysis & Reporting (BI, Dashboards)

Automate with Machine Learning (ML) & Artificial Intelligence (AI)

Archive Data & Ensure Long-Term Access/Availability

C.) System TYpes

Websites (Internal & External)

Content Management Systems (CMS)

Quality Management Systems (QMS)

Learning Management Systems (LMS)

Knowledge Management Systems (KMS)

Training Management Systems (TMS)

Laboratory Information Management Systems (LIMS)

Research Use Only (RUO) & Diagnostic Systems

Electronic Trial Master Files (eTMF)

Medical Device Master Files (MAF)

Regulatory Information Management Systems (RIMS)

D.) COMPLIANCE & SECURITY

Align Processes, Systems & Data

Create Test Plans & Use Cases

Create Event Logs & Test Reports

Track & Mitigate Defects: Program Coding & Configurations

Create Fault Tolerance & System Recovery Plans

Perform & Ensure Qualification/Validation:

• Installation Qualification (IQ)

• Operation Qualification (OQ)

• Performance Qualification (PQ)

Test for Vulnerabilities & Potential Hacking Vectors

E.) METHODS, FORMATS & STANDARDS

Agile, Scrum, Waterfall & DevOps

Test & Behavioral Driven Development (TDD, BDD) & Domain Driven Design (DDD)

Darwin Information Typing Architecture (DITA)

Extensible Markup Language ( XML)

Standard Generalized Markup Language (SGML)

SGML-Family Markup Language (GML, SGML, XML, HTML)

Regulatory: FDA, EU, OSHA, GDPR, IDMP

A.) STRATEGIC PLANNING

Establish operating frameworks, including governance & processes for project managers, project management offices (PMO) & teams

Develop vision, mission, objectives, strategies, and actions (VMOSA) for teams, departments & organizations

Assess & develop resource models aimed to meet near-to-mid-term objectives

Assess maturity of project management & project management office (PMO) models

Develop organizational metrics, dashboards & scorecards

Create project prioritization capabilities

Establish project management processes & tools (i.e., toolkit)

B.) TACTICAL PLANNING

Develop project charters

Develop communication plans & manage project information accordingly

Develop comprehensive program/project plans & manage associated scope changes

Develop & manage project budgets/timelines

Develop RACI/RASCI

Conduct in-depth stakeholder analyses

Perform Root Cause Analyses (RCA)

C.) EXECUTION & CLoseout

Conduct project kickoff meetings focused on project objectives, milestones, & overall goals

Manage relationships & information sharing between writers, editors & subject matter experts (SME)

Update schedule resources, tasks, milestones & deliverables

Track & regularly report project progress to stakeholders

Assess, track & mitigate issues & risks

Manage & maintain oversight responsibility for the production of final deliverables

Maintain accountability in ensuring all deliverables meet required style, regulatory & quality standards

Conduct project closeouts to ensure lessons are learned & appropriate knowledge is transferred

D.) METHODS, FORMATS & STANDARDS

Project Management Body of Knowledge (PMBOK)

VMOSA Model: Vision, Mission, Objectives, Strategies & Actions