A.) TECHNICAL AUTHORING & QUALITY MANAGEMENT

• AI-Powered Technical Authoring / Technical Documentation

  • Procedural Documents made consistent through AI

    • Policies

    • SOPs

    • Work Instructions

    • Job Breakdown Sheets

  • Manuals

    • Installation, Operation, User & Procedural Manuals

    • Maintenance & Repair Manuals with AR overlay capability

    • Safety Manuals & AR-enhanced Safety Training Materials

  • Illustrated Parts Lists & Catalogues with automated descriptions

  • Sheets

    • Data Sheets

    • Spec Sheets

    • Material Safety Data Sheet (MSDS)

    • Safety Data Sheet (SDS)

• Drawings & Illustrations

  • Product Illustrations & Detailed Breakdowns (3D rendering)

  • Technical Drawing / Illustration with AI-generated callouts

• AI-assisted technical writing (Etteplan HyperSTE for Simplified Technical English)

• Neural machine translation (NMT) with domain-specific terminology

B.) VISUALIZATION & MULTIMEDIA PRODUCTION

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

• AI-enhanced Computer-Aided Design (CAD) integration

• Product Illustrations & Detailed Breakdowns with 3D rendering

• Technical Drawing / Illustration with AI-generated callouts

• Video Production with AI editing capabilities

• Still Shot Photography with ML-enhanced processing

• Interactive digital documentation with embedded multimedia

• Digital twin visualization for manufacturing systems

• AR/VR-enabled technical illustrations (PTC Vuforia integration)

• Interactive 3D models with AR viewing

• Remote expert assistance with AR video streaming

C.) DATA & CONTENT MANAGEMENT SYSTEMS

• Structured Data Development in XML & DITA

• S1000D with automated compliance checking

• Structured Product Labeling (SPL) with AI validation

• AI-driven content strategy and taxonomy development

• ML-powered metadata enrichment and auto-tagging

• Automated content reuse recommendations ("Write Once, Publish Everywhere")

• AI-enhanced document conversions (FrameMaker, Interleaf to DITA)

• ML-assisted migrations of critical business information

• Neural search capabilities for rapid content retrieval

• Predictive analytics for content lifecycle management

• Real-time validation with AI quality checks

D.) REGULATORY & COMPLIANCE DOCUMENTATION

• Computer System Validation (CSV), including Laboratory Information Management Systems (LIMS)

• AI/ML model validation documentation for medical devices

• Digital twin and simulation validation protocols

• 21 CFR Part 11 compliance and electronic records validation

• Installation / Operational / Performance Qualification (IQ/OQ/PQ)

• MLOps documentation support (model versioning, data lineage, experiment tracking)

• Model monitoring and observability frameworks (drift detection, performance tracking)

• SLO/SLA documentation for AI/ML systems in production

• CI/CD pipeline documentation for model deployment

• Automated testing protocols (unit, integration, performance)

• Incident response and rollback procedures for AI systems

• Infrastructure as Code documentation (Terraform, CloudFormation, Kubernetes)

• CAPA (Corrective and Preventive Action) documentation

• FDA 483 observation response support

• Regulatory submission preparation and review (510(k), PMA, CE Technical Files)

• Audit readiness and regulatory gap analysis

• Root cause analysis for quality events

E.) REGULATORY FRAMEWORKS & STANDARDS

• Current Good Manufacturing Practice (GMP)

• Current Good Laboratory Practice (GLP)

• Current Good Clinical Practice (GCP)

• Medical Device Regulation (MDR)

• In Vitro Diagnostic Regulation (IVDR)

• General Data Protection Regulation (GDPR)

• Identification of Medicinal Product (IDMP)

• FDA requirements (21 CFR Part 11, 510(k), PMA)

• EU regulations (CE Technical Files, Post-Market Surveillance)

• ISO 13485:2016 and ISO 14971 compliance verification

  NOTE: ISO 9001:2015 & ISO 13485:2016 Certified Quality Management Systems. Proven delivery includes VP.S ENCORE® Heart Transport Device (8-day turnaround, FDA Breakthrough Device support), Global Biotech LIMS validation (150-page user manual, 7 subsidiaries, zero audit findings), and Fortune 50 pharmaceutical documentation (200+ Job Breakdown Sheets, 1,000+ pages using TWI methodology).

A.) AI/AR/VR-ENHANCED TRAINING DELIVERY

• AR-enabled Job Breakdown Sheets using PTC Vuforia platform

• RealWear AR headsets for hands-on training capture and delivery

• Real-time AR overlays for equipment operation guidance

• Remote expert support through AR video streaming

• Immersive VR training environments for complex procedures

• Risk-free VR practice scenarios for critical operations

• Virtual facility tours and safety training in VR

• Digital twin training environments for manufacturing systems

• Personalized learning paths based on ML algorithms

• AI-driven competency assessment and gap analysis

B.) TRAINING PROGRAMS & METHODOLOGIES

Training Within Industry (TWI) Job Breakdown Sheets

• Instructor-led training with AI presentation tools

• AI-powered eLearning with adaptive content delivery

• AR/VR simulations for immersive hands-on learning

• Structured on-the-job training (OJT) with AI monitoring

• ML-enhanced coaching & mentoring with performance analytics

• Competency-based training frameworks

• Train-the-trainer programs

• Microlearning modules with AI content optimization

• Interactive case studies with AI scenario generation

C.) AI-POWERED TRAINING CONTENT DEVELOPMENT

• Automated training content generation from SOPs/WRKs using NLP

• AI-powered video editing and production

• 3D animations for complex procedures and mechanisms

• Interactive videos with branching scenarios

• AR-enhanced job aids and quick reference guides

• VR training modules for equipment operation

• Mobile-optimized microlearning content

• Gamified learning experiences with AI adaptation

• Neural machine translation for multilingual training (RWS, Big Language Solutions)

• Simplified technical language using Etteplan HyperSTE AI platform

D.) COMPETENCY & PERFORMANCE MANAGEMENT

• Real-time competency tracking dashboards with AI analytics

• Predictive analytics for training needs identification

• ML-based performance trend analysis

• Automated skills gap identification and recommendations

• AI-powered remedial training planning

• Intelligent scheduling for retraining/recertification

• AI-proctored knowledge assessments

• VR/AR-based practical evaluations

• Automated performance observation analysis (RealWear integration)

• Competency matrices with AI validation and continuous improvement tracking

E.) REGULATORY FRAMEWORKS & TECHNOLOGY PARTNERSHIPS

• Current Good Manufacturing Practice (GMP) training

• Current Good Laboratory Practice (GLP) training

• Current Good Clinical Practice (GCP) training

• Medical Device Regulation (MDR) compliance training

• GDPR compliance and IDMP training programs

• PTC Vuforia for AR (proven implementation: Johnson & Johnson divisions)

• RealWear AR devices for industrial training environments

• AIXI for predictive analytics in competency management

• CourtSquare Group for life sciences-specific AI applications

• RWS and Big Language Solutions for AI-powered multilingual training

• Etteplan HyperSTE for simplified technical English validation

  NOTE: ISO 9001:2015 & ISO 13485:2016 Certified Quality Management Systems. Proven delivery using TWI methodology (200+ Job Breakdown Sheets for Fortune 50 pharmaceutical manufacturer, 1,000+ pages). AR/VR capabilities demonstrated through Johnson & Johnson projects (Janssen, Ethicon divisions) and 6-week robotic radiotherapy training program development.