Quality, Compliance & operational excellence
Ensure control of your business and mitigation of potential risks.
Our experts will develop and document clear and concise processes and procedures, including as it relates to your systems, to ensure control of your business and mitigation of risks, such as a CAPA or 483.
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
data & Documentation
Transform complex information into clear, concise and targeted content.
Transform highly complex information into clear, concise, readily digestible content. Our company has 50 years of experience with virtually every type of document and content management system.
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
IT SYSTEMS
Integrate and streamline your systems to enhance decision making and productivity.
Make sure all IT hardware and software components integrate seamlessly, share information in real time, and provide meaningful insights on demand.
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
Project & PROGRAM MANAGEMENT
Move your projects and programs into action and build confidence around your objectives.
Our professionals have the experience, methodology and innovative technology to manage projects on any scale. Ensure all stakeholders understand the scope of work, financial obligation, best practices, regulations and potential risks.
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
try a complimentary session and see if it’s right for you.
We offer a free 30 to 90 minute consultation with no pressure or obligation.