Investor Pitch Data: CODITECT WO Module

Date: 2026-02-13 | Classification: Confidential — Fundraising
Module: Autonomous Change Control for Regulated Bioscience

The One-Liner

CODITECT is the first AI-agent platform that makes change control autonomous for regulated bioscience — turning a 6-week manual compliance process into a 6-hour orchestrated workflow.

Problem (Pain Quantified)

Pain Point	Current State	Data Point
Manual change control	15–40 hours per change record	Industry benchmark: ~$2,500–$8,000 fully loaded cost per change
Compliance failures	23% of FDA 483 observations cite inadequate change control	FDA FY2024 inspection data
Disconnected tools	Avg. bioscience QMS stack = 4.7 separate tools	Greenlight Guru/MasterControl customer surveys
Audit preparation	80–120 hours per regulatory audit	Industry average for mid-market biotech
Vendor coordination	30% of change cycle time is waiting on vendor documentation	WO system analysis (Appendix A scenario)
Agent-driven changes	0 tools exist for AI agent change control	Competitive analysis — greenfield

Cost of Inaction

A mid-market biotech (200 employees, 50 validated systems) processes ~200–400 change records/year:

Metric	Manual Process	With CODITECT	Savings
Hours per change	25 hrs avg	4 hrs avg (84% automated)	21 hrs
Annual change hours	7,500 hrs	1,200 hrs	6,300 hrs
Fully loaded cost ($150/hr)	$1.125M	$180K	$945K/yr
Audit prep time	100 hrs/audit × 2/yr	15 hrs/audit × 2/yr	170 hrs
483 observation risk	23% citation rate	<5% (structural compliance)	78% reduction
Time-to-compliance for changes	6 weeks avg	5 days avg	83% reduction

ROI: $945K savings / $120K ACV = 7.9× first-year return

Solution

What CODITECT's WO Module Does

Autonomous Orchestration — AI agents decompose a Master Work Order into task-level Linked WOs, assign resources, schedule execution, and coordinate vendors — automatically.
Structural Compliance — Change control is database-enforced (append-only audit trails, immutable signatures, state machine guards), not policy-based. Agents cannot bypass compliance because the architecture prevents it.
Intelligent Routing — Model router selects Opus for compliance decisions, Sonnet for complex logic, Haiku for boilerplate — delivering 40–60% token cost reduction while maintaining audit-grade quality.
Hierarchical Change Control — Master/Linked WO hierarchy maps real-world change processes (e.g., Win10→Win11 lab upgrade = 1 Master + 6 Linked WOs with dependencies).

Technical Differentiators

Capability	CODITECT	ServiceNow	Veeva QMS	MasterControl
AI agent orchestration	✅ Native	❌ None	❌ None	❌ None
Autonomous change decomposition	✅ Agent-driven	❌ Manual	❌ Manual	❌ Manual
Immutable audit trail	✅ DB-enforced	⚠️ Configurable	✅ Yes	✅ Yes
Multi-agent coordination	✅ 7 agent types	❌ None	❌ None	❌ None
21 CFR Part 11 e-signatures	✅ Native	⚠️ Add-on	✅ Native	✅ Native
Work order hierarchy	✅ Master/Linked DAG	⚠️ Limited	❌ None	❌ None
Token cost optimization	✅ Model routing	N/A	N/A	N/A
Vendor coordination portal	✅ Agent-driven	⚠️ Workflow	❌ None	❌ None

Market Opportunity

Metric	Value
TAM	$7.2B (2026) — QMS + WO + CMMS in regulated life sciences
SAM	$378M (2026) — Cloud-ready, mid-market, compliance-active, AI-adopting
SOM (Y5)	$26.25M ARR — 150 customers × $175K ACV
Market growth	13.6% CAGR (biotech QMS segment)
Cloud adoption	67% of QMS deployments (2025), growing
Change mgmt module growth	13%+ CAGR — fastest QMS segment

Beachhead: CDMOs (Contract Development & Manufacturing Organizations)

Fastest growing QMS end-user at 17% CAGR
Manage validated systems for multiple clients simultaneously
Highest change volume per employee
Most pain from disconnected tools (avg. 6.2 per CDMO)
Regulatory compliance is existential — lose certification = lose business

Business Model

Revenue Stream	Pricing	% of Revenue (Y3)
Platform fee (WO Engine)	$2,500/mo flat	35%
Agent seat licenses	$150/seat/mo	30%
Compliance module	$1,500/mo add-on	15%
Professional services	Project-based	15%
Success-based (audit pass)	Performance bonus	5%

Gross margin target: 78% (SaaS + AI compute costs offset by model routing optimization)

Unit Economics (Y3 Steady State)

Metric	Target
ACV	$120K
CAC	$35K
LTV	$480K (4-year avg. life)
LTV:CAC	13.7×
Payback period	3.5 months
Net revenue retention	125% (expansion from compliance + platform add-ons)
Gross margin	78%

Traction & Milestones

Phase	Timeline	Milestone
Architecture (current)	Q1 2026	Complete system design, ADRs, C4 model, compliance mapping
POC	Q2 2026	Core WO lifecycle, audit trail, basic API — 1 design partner
Pilot	Q3 2026	Resource matching, hierarchy/DAG, e-signatures, Vault — 3 design partners
Beta	Q4 2026	Agent adapter, compliance engine, event bus, observability — 5 beta customers
GA	Q1 2027	Production release, 3 paying customers
Growth	2027–2028	12–35 customers, Series A fundraise

Team Advantage

Attribute	Relevance
30+ years healthcare IT	Deep domain expertise in regulated environments
GRAIL Inc. (FDA Class II medical device) experience	First-hand 21 CFR Part 11 implementation
Google AI Accelerator participant	Access to AI/ML resources, mentorship, ecosystem
Serial entrepreneur track record	Proven ability to build and scale enterprise products
Full-stack architecture capability	CTO-led technical execution, no dependency on outsourced architecture

Ask

Item	Amount	Use
Pre-seed / Seed	$1.5–2.5M	12-month runway: 2 engineers + 1 sales/BD + infrastructure + compliance certification
Key hires	2 backend engineers (TypeScript/Python, regulated software experience)
Milestones for next raise	10 paying customers, $850K ARR, SOC 2 Type I certification

Key Metrics to Track

Category	Metric	Target
Product	WO cycle time reduction	>80% vs. manual baseline
Product	Compliance first-pass rate	>95%
Product	Agent task completion rate	>90%
Business	Customer acquisition	3 design partners → 12 early adopters (Y2)
Business	ARR growth	$150K → $1M → $4.2M (Y1–Y3)
Business	Net revenue retention	>120%
Compliance	FDA 21 CFR Part 11 coverage	100% by Q3 2026
Compliance	SOC 2 Type I	Achieved by Q4 2026
Technical	Token cost per WO	<$2.50 avg (via model routing)

The One-Liner​

Problem (Pain Quantified)​

Cost of Inaction​

Solution​

What CODITECT's WO Module Does​

Technical Differentiators​

Market Opportunity​

Beachhead: CDMOs (Contract Development & Manufacturing Organizations)​

Business Model​

Unit Economics (Y3 Steady State)​

Traction & Milestones​

Team Advantage​

Ask​

Key Metrics to Track​