Production site optimization
Business Case Development Methodology
ITOT-Advice's Proven Framework:
1. Value Discovery Workshop
Common Pitfalls We Avoid:
❌ Technology-first thinking - "We need an MES" without defining why
1. Value Discovery Workshop
- Facilitated sessions with stakeholders (Operations, IT, Quality, Finance)
- Identify pain points and opportunities
- Prioritize based on strategic alignment
- Measure baseline metrics (downtime, cycle times, errors, costs)
- Document manual processes and inefficiencies
- Calculate hidden costs (rework, delays, holding costs)
- Define specific integration architecture
- Specify expected improvements with industry benchmarks
- Validate assumptions with subject matter experts
- Investment Costs:
- Software licensing
- Hardware/infrastructure
- Implementation services
- Change management and training
- CSV validation costs
- Ongoing support and maintenance
- Return Calculation:
- Direct savings (labor, materials, energy)
- Efficiency gains (time savings, throughput increase)
- Risk reduction (quality, compliance)
- Revenue opportunities (faster time-to-market, capacity increase)
- Sensitivity Analysis:
- Conservative, realistic, and optimistic scenarios
- Risk-adjusted returns
- Break-even analysis
- Phased approach balancing quick wins with long-term value
- Resource requirements and timeline
- Risk mitigation strategies
- Success metrics and governance
Common Pitfalls We Avoid:
❌ Technology-first thinking - "We need an MES" without defining why
❌ Unclear ROI - "It will improve efficiency" without quantification
❌ Scope creep - Boiling the ocean instead of targeted use cases
❌ Ignoring change management - Technical solution without organizational readiness
❌ One-size-fits-all - Applying same solution regardless of site maturity
ITOT-Advice's Value:
✅ Business outcome focus - Start with "what problem are we solving?"
ITOT-Advice's Value:
✅ Business outcome focus - Start with "what problem are we solving?"
✅ Quantified benefits - Clear financial justification
✅ Prioritized roadmap - Sequence based on value and feasibility
✅ Realistic implementation - Account for organizational and technical constraints
✅ Proven methodologies - Learned from 24 years of global implementations
Typical ROI Across Use Cases
Based on our experience across pharmaceutical production sites:
Typical ROI Across Use Cases
Based on our experience across pharmaceutical production sites:
Use CasePayback PeriodAnnual ROIComplexityReal-Time Visibility6-9 months200-300%MediumPredictive Maintenance8-12 months150-250%HighElectronic Batch Records10-18 months100-200%HighSupply Chain Integration4-8 months250-400%MediumQuality/CAPA Integration6-10 months180-280%MediumEnergy Management5-9 months200-300%Low-MediumGlobal Network Optimization6-15 months150-300%Very High
Note: Actual results vary by site size, current maturity, and specific circumstances
Getting Started
ITOT-Advice helps you:
Note: Actual results vary by site size, current maturity, and specific circumstances
Getting Started
ITOT-Advice helps you:
- Assess your current IT/OT maturity
- Identify highest-value integration opportunities
- Quantify business cases for prioritized use cases
- Design integration architecture aligned with ISA-95
- Implement with proven methodologies and CSV compliance
- Optimize continuously based on performance data
Typical ROI Across Use Cases
Based on 24 years of experience across pharmaceutical production sites
| Use Case | Payback Period | Annual ROI | Complexity |
|---|---|---|---|
| Real-Time Visibility | 6-9 months | 200-300% | Medium |
| Predictive Maintenance | 8-12 months | 150-250% | High |
| Electronic Batch Records | 10-18 months | 100-200% | High |
| Supply Chain Integration | 4-8 months | 250-400% | Medium |
| Quality/CAPA Integration | 6-10 months | 180-280% | Medium |
| Energy Management | 5-9 months | 200-300% | Low-Medium |
| Global Network Optimization | 6-15 months | 150-300% | Very High |
Note: Actual results vary by site size, current maturity, and specific circumstances
Getting Started
ITOT-Advice helps you:
Getting Started
ITOT-Advice helps you:
- Assess your current IT/OT maturity
- Identify highest-value integration opportunities
- Quantify business cases for prioritized use cases
- Design integration architecture aligned with ISA-95
- Implement with proven methodologies and CSV compliance
- Optimize continuously based on performance data
1. Real-Time Production Visibility
- 15-20% reduction in production downtime
- 25-30% reduction in manual reporting time
- 10-15% improvement in OEE
- Faster response to production issues