Consultant-quality SOP drafts in minutes
AI-powered document generation customized for your organization. Stop starting from scratch. Stop paying consultants $1,500 per SOP.
Early access — waitlist members get priority at launch.
Writing SOPs from scratch is broken
Every quality manager knows the pain. Here's what you're dealing with today.
Blank page syndrome. Starting from scratch for each procedure. Unsure what to include or what level of detail auditors expect.
$1,500+ per SOP from consultants. A full QMS documentation package easily exceeds $45,000. Most startups can't justify that spend.
Generic templates don't fit. Downloaded templates aren't customized to your company. You end up rewriting most of it anyway.
Weeks of delays per document. Each SOP takes 1-2 weeks from a consultant. Your audit timeline keeps slipping.
AI that writes like a regulatory expert
Answer questions about your organization. Get publication-ready SOPs that reflect how you actually work.
Customized to your operations. SOPs reflect your company size, QMS maturity, and target markets.
Multi-standard compliant. Written to ISO 13485 and the FDA QMSR (21 CFR 820), mapped clause-by-clause to the standard you select.
Professional QMS formatting. Proper headers, revision control, approval blocks, references. Ready from the moment you download.
Minutes, not weeks. Complete the wizard in 10 minutes. Have your SOPs in under 5. Review and approve same day.
Three steps to compliant SOPs
Tell us about your company
Company size, QMS maturity, target markets (US, EU, etc.), key roles and responsibilities. This shapes every SOP we generate.
Configure your packages
Select which SOP packages to generate, customize process-specific options, choose investigation depth and review frequencies.
Download and deploy
AI generates your customized SOPs. Download as Word documents, review with your team, approve and implement. Done.
16 SOP packages, full QMS coverage
Every package generates a complete, consultant-quality draft SOP plus matching Work Instruction, customized to your organization.
CAPA
Corrective and preventive action with root cause analysis and effectiveness checks.
NCR
Nonconforming product control with disposition workflows and MRB process.
Risk Management
Product and process risk management aligned to ISO 14971 principles.
Management Review
Leadership review procedure with agenda, inputs, outputs, and action tracking.
Document Control
Document lifecycle, approval workflow, and revision control.
Record Control
Quality record identification, storage, and retention schedule.
Quality Manual
Top-level QMS description with scope, exclusions, and process interactions.
Quality Policy
Quality policy and objectives with measurable targets and review cadence.
Training
Competency framework, training matrix, and retraining triggers.
Resource Planning
Resource needs assessment and allocation aligned to quality objectives.
Infrastructure
Equipment master list, preventive maintenance, and calibration control.
Work Environment
Environmental monitoring, gowning, and contamination control.
Design Control
Design history file, design reviews, verification, and change management.
Process Validation
IQ/OQ/PQ protocols for processes that can't be fully verified by inspection.
Purchasing & Suppliers
Supplier evaluation, approval, monitoring, and quality agreement checklist.
Complaint Handling In dev
Customer complaint intake, investigation, and reportability determination.
Compare your options
See how SOP Builder stacks up against the alternatives.
| Approach | Cost per SOP | Time per SOP | Customization |
|---|---|---|---|
| Write from scratch | $0 + your time | 1-2 weeks | Full, but requires expertise |
| Generic templates | $50-200 | 3-5 days to customize | Limited, must rewrite |
| Consultant | $1,500+ | 1-2 weeks | High, but expensive |
| SOP Builder | From $499/SOP | ~5 minutes | High, AI-customized |
Simple, transparent pricing
Pay per SOP. Volume discounts available. No subscription required.
Per SOP
per SOP + Work Instruction pair
- SOP + Work Instruction (2 docs)
- AI-customized to your company
- Verified against ISO clauses
- Professional DOCX format
Volume: $449/ea (3+) · $399/ea (5+) · $374/ea (10+)
Join the waitlistProcess Package
per process area (5 SOP+WI pairs)
- 5 related SOPs + Work Instructions
- Complete process area coverage
- CAPA, Training, Doc Control, NCR, or Risk
- 80-94% savings vs. consultants
Full QMS Bundle
Best Valueall SOPs + WIs for one standard (50+ docs)
- Complete QMS documentation
- All process areas included
- 89-95% savings vs. consultants
- Single standard (ISO 13485, FDA QMSR, etc.)
Coverage across multiple standards (ISO 13485 + FDA QMSR + EU MDR + AS9100D) or a custom package for a larger organization? Join the waitlist and we'll set up a scoping call.
Works with your QMS
Gap analysis integration
Found a gap in your CAPA procedure? Pick the matching package and generate a compliant replacement the same day.
Word document output
Download as .docx files ready for your document control system or eQMS.
eQMS compatible
Works with Greenlight Guru, Qualio, MasterControl, and any system that accepts Word documents.
You own the documents
Full ownership. Modify, update, and use without restriction or ongoing fees.
What quality managers ask
Are these just templates with my company name inserted?
Will these pass an audit?
Can I edit the documents after generation?
What if I need a custom SOP not in your packages?
How does this compare to hiring a consultant?
Is 21 CFR Part 11 compliance addressed?
Be first at launch
SOP Builder is in limited release. Join the waitlist for priority access plus a personal walkthrough.
Join the waitlistFrom $499/SOP at launch. See pricing options