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SOP Builder

Audit-ready SOPs in minutes

AI-powered document generation customized for your organization.
Stop starting from scratch. Stop paying consultants $1,500 per SOP.

Generate your first SOP See how it works
SOP Builder wizard showing standard selection and package configuration
~5 min
Generation time
90%
Cost reduction vs. consultants
3
Core SOP packages
6
Global markets

The problem

Writing SOPs from scratch is broken

Every quality manager knows the pain. Here's what you're dealing with today.

01
Blank page syndrome. Starting from scratch for each procedure. Unsure what to include or what level of detail auditors expect.
02
$1,500+ per SOP from consultants. A full QMS documentation package easily exceeds $45,000. Most startups can't justify that spend.
03
Generic templates don't fit. Downloaded templates aren't customized to your company. You end up rewriting most of it anyway.
04
Weeks of delays per document. Each SOP takes 1-2 weeks from a consultant. Your audit timeline keeps slipping.

The solution

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. Meets ISO 13485, FDA 21 CFR Part 820, EU MDR, and more. One SOP covers all requirements.
Audit-ready 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.
What you get
SOP document (.docx)
Work Instruction (.docx)
ISO clause mapping
Revision control headers
Full ownership, no restrictions
Process

Three steps to compliant SOPs

1

Tell us about your company

Company size, QMS maturity, target markets (US, EU, etc.), key roles and responsibilities. This shapes every SOP we generate.

5 min
2

Configure your packages

Select which SOP packages to generate, customize process-specific options, choose investigation depth and review frequencies.

5 min
3

Download and deploy

AI generates your customized SOPs. Download as Word documents, review with your team, approve and implement. Done.

~5 min
Start the wizard
Packages

SOPs you can generate today

Quality Core

CAPA

Corrective and Preventive Action procedure compliant with ISO 13485 8.5.2/8.5.3 and FDA 820.100.

  • Root cause analysis methods
  • Investigation workflows
  • Effectiveness verification
  • Closure criteria
People

Training

Training and Competence procedure compliant with ISO 13485 6.2 and FDA 820.25.

  • Training needs assessment
  • Competency evaluation methods
  • Retraining triggers
  • Record requirements
Foundation

Document Control

Document and Record Control procedure compliant with ISO 13485 4.2.4/4.2.5 and FDA 820.40/820.180.

  • Document lifecycle management
  • Approval workflows
  • Revision control
  • Retention requirements

NCR, Complaint Handling, and Quality Manual coming soon

Join the waitlist for early access when new packages launch.

Supported markets

United States (FDA) European Union (CE/MDR) Canada (Health Canada) United Kingdom (UKCA) Japan (PMDA) Australia (TGA)

Compare your options

See how SOP Builder stacks up against the alternatives.

Comparison of SOP creation approaches by cost, time, and customization
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 $199/SOP ~5 minutes High, AI-customized
Write from scratch
Cost$0 + your time
Time1-2 weeks
CustomizationRequires expertise
Generic templates
Cost$50-200
Time3-5 days
CustomizationLimited
Consultant
Cost$1,500+
Time1-2 weeks
CustomizationHigh, but expensive
SOP Builder
CostFrom $199/SOP
Time~5 minutes
CustomizationHigh, AI-customized

Simple, transparent pricing

Pay per SOP. Volume discounts available. No subscription required.

Per SOP

$199

per SOP + Work Instruction pair

  • SOP + Work Instruction (2 docs)
  • AI-customized to your company
  • Verified against ISO clauses
  • Professional DOCX format

Volume: $179/ea (3+) · $160/ea (5+) · $149/ea (10+)

Get started
Most Popular

Process Package

$1,497

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
Get started

Full QMS Bundle

Best Value

$7,997

all SOPs + WIs for one standard (50+ docs)

  • Complete QMS documentation
  • All process areas included
  • 89-95% savings vs. consultants
  • Multi-standard from $12,997
Get started

Integration

Works with your QMS

Gap analysis integration

Found a gap in your CAPA procedure? Generate a compliant replacement directly from audit findings.

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?
No. The AI generates content based on your specific answers about company size, QMS maturity, target markets, and process preferences. A startup's CAPA procedure looks different from an enterprise's. The same options produce genuinely different documents.
Will these pass an audit?
The generated SOPs meet the requirements of ISO 13485 and FDA 21 CFR Part 820. However, you must still review them for accuracy to your operations, train your staff, and implement them properly. An auditor will verify implementation, not just documentation.
Can I edit the documents after generation?
Yes. You receive standard Word (.docx) files. Edit them however you need — add company-specific details, adjust workflows, insert additional requirements. You own the documents completely.
What if I need a custom SOP not in your packages?
We're continuously adding new packages. Currently we offer CAPA, Training, and Document Control. NCR, Complaint Handling, and Quality Manual are coming soon. For custom procedures, our consulting team can help.
How does this compare to hiring a consultant?
A consultant typically charges $1,500+ per SOP and takes 1-2 weeks per document. SOP Builder produces comparable quality in minutes for a fraction of the cost. For complex situations or full QMS builds, you might still want consulting support.
Is 21 CFR Part 11 compliance addressed?
If you select "eQMS" as your system type and target the US market, the generator automatically includes 21 CFR Part 11 requirements for electronic signatures and records in your procedures.

Generate your first SOP

Audit-ready documentation in minutes. No consultant required.

Start generating

From $199/SOP. See pricing options