Business process management (BPM)

Map Current Processes

Identify Weak & Inefficient Processes

Design, Map & Implement New Processes

Incorporate Maps into Procedural Documentation

Determine System, Process & Data Relationships

Procedural Documentation

Policies, Manuals & Objectives

Standard Operating Procedures (SOP)

Work Instructions (WRK)

Job Aids & Enabling Documents

Operational Refinement

Develop Insight & Control through Metrics

Enable Modeling & What-If Analyses

Streamline and Automate Operations

Ensure Active Monitoring

Develop Improved Track & Trace Capabilities

Drive Adoption through Improved User Experiences

Review, Refine & Develop Training Programs

Informational Systems

Develop Content Strategies & Information Architectures

Develop & Deploy Mobile-based:

• Business Process Management Systems (BPM)

• Quality Management Systems (QMS)

Migrate to XML- & DITA-Based Approaches

• Facilitate Content Development

• Enable Efficient Content Use & Reuse

• Enhance Search Capabilities

• Enable Transparency to Regulators & Partners

compliance & Security

Identify Requirements for:

• Compliance Training Programs

• Managing Specific Types of Healthcare Information, including as it relates to GDPR

• HIPAA IT Equipment & Access and Software Systems & Communications

• HIPAA Retention Policies for Documents & Databases

• Legal & Financial Risks Associated with OIG Penalties

• Securing Mobile IT Equipment

Implement:

• “Proactive Approaches” to Privacy & Security

• “Right to Know” Documentation for Employees

Enforce all laws & operating standards that are required for your projects: FDA, EU, HIPAA, GDPR, ISO, FTC, OSHA, OIG and many others.

• Comply with ISO Identification of Medicinal Product (IDMP) Standards

Health & safety

Identify Requirements for:

• Facilities & Safety Equipment

• Safety Training Programs

Implement:

• Safety Response Programs

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

Core Competencies

Illustration & Computer-Aided Design (CAD)

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

Video Production & Still Shot Photography

Technical Authoring / Technical Documentation

Editing & Proofreading

Translation Management

Structured Data Development & Management

Content Strategy & Management

Publishing & Delivery (Digital & Print)

Training Course Development

DOCUMENTATION TYPES & Training Opportunities

Policies, Manuals & Objectives

Standard Operating Procedures (SOP)

Work Instructions (WRK)

Job Aids & Enabling Documents

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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., HIPAA, OSHA)

DATA & DOCUMENT MANAGEMENT

Develop, Deliver & Manage Structured Data

Identify Core Data & Documents and their Respective Systems

Facilitate Selection of Data & Document Systems

Recommendations for IT Equipment & Devices

Manage Conversions of Documents from Legacy Software (FrameMaker, Interleaf, etc.) into DITA

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

Provide Extract, Transform & Load (ETL) Services

Develop Content Strategies

Implement Systems:

• Quality Management (QMS)

• Content Management (CMS)

• Learning Management (LMS)

• Knowledge Management (KMS)

Build Taxonomies

Add Enrichment & Metadata

Optimize Content Reuse

Validate Data & Documents

METHODS, FORMATS & Standards

Validate Data & Documents

Simplified Technical English (STE)

DTD & FOSI

DITA, XML (S1000D), SGML & DocBook

Structured Product Labeling (SPL)

Regulatory: FDA, EU, HIPAA, OSHA, OIG, DADS, FTC, GDPR & IDMP

SYSTEM CHECKUPs & ROADMAPPING

Map Current & Future State Processes & Systems, including 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, Host & Maintain Intranet & Internet Websites

MIGRATIONs, INTEGRATIONs & STORAGE

Migrate Data, Documents & Systems

Integrate Databases & Develop Data Warehouses

Organize Data into Strategic Business Units & Master Data Layers

Establish Application Programming Interfaces (API)

Enable Rigorous Data Analysis & Reporting (BI, Dashboards)

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

Archive Data & Ensure Long-Term Availability of Resources

System TYpes

Intranet & Internet Sites

Quality Management (QMS)

Content Management (CMS)

Learning Management (LMS)

Knowledge Management (KMS)

Enterprise Resource Planning (ERP)

Customer Relationship Management (CRM)

Electronic Trial Master File (eTMF)

Electronic Medical Records (EMR)

Regulatory Information Management (RIMS)

Laboratory Information Management (LIMS)

Research Use Only (RUO) & Diagnostic

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

Support Installation, Operation & Performance Qualification (IQ/OQ/PQ)

Perform Verification & Validation

Manage User Provisioning, Active Directory & Single Sign On (SSO)

Test for Vulnerabilities & Potential Hacking Vectors

Test Regulated Environments for Compliance (GDPR, IDMP)

METHODS, FORMATS & STANDARDS

Agile, Scrum, Waterfall & DevOps

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

DITA, XML (S1000D), SGML & DocBook

Regulatory: FDA, EU, HIPAA, OSHA, OIG, DADS, FTC, GDPR, IDMP

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)

TACTICAL PLANNING

Conduct in-depth stakeholder analyses

Develop comprehensive program/project plans & manage associated scope changes

Develop communication plans & manage project information accordingly

Develop & manage project budgets/timelines

Develop RACI/RASCI

Develop project charters

EXECUTION

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

CLOSEOUT

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

METHODS, FORMATS & STANdARDS

Project Management Body of Knowledge (PMBOK)

Lean Six Sigma (Lean), Kanban, Scrum & Waterfall