Pricing

Flexible plans for regulated teams — built for speed, compliance, and scale.

All plans include electronic signatures designed to support 21 CFR Part 11 requirements, document control, audit logging, and secure role-based access.

Built-in support for:

ISO 13485ISO 9001FDA 21 CFR Part 11

Core

Lean QMS for early-stage teams building their foundation.

$1,500/month

Or $16,000/year — save 11%

30-day free trial included

Unlimited users on all plans
Up to 5 GB document storage
  • Unlimited users on all plans (no per-seat pricing)
  • Document control & version management
  • CAPA and change control workflows
  • Approval routing & electronic signatures
  • Full audit trail visibility
  • Role-based permissions
Standard support (email + onboarding)
Supports: 21 CFR Part 11, ISO 13485, ISO 9001

Best for: startups establishing initial compliance or preparing for first audits.

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Scale

For growing companies preparing for inspections or expanding quality operations.

$3,000/month

Or $32,000/year — save 11%

30-day free trial included

Unlimited users on all plans
Up to 20 GB document storage
  • Everything in Core, plus:
  • Included IQ/OQ Validation Package
  • Bulk data export capabilities
  • Dedicated onboarding call
  • SLA-backed response times
Priority support (24h response)
Supports: 21 CFR Part 11, ISO 13485, ISO 9001

Best for: teams scaling quality infrastructure ahead of audits or submissions.

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Enterprise

For established organizations requiring tailored compliance and dedicated support.

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Custom pricing based on your needs

Unlimited users on all plans
Custom storage & infrastructure document storage
  • Everything in Scale, plus:
  • Regulatory audit preparation consulting
  • Advanced data export and migration assistance
  • Custom integrations and training sessions
  • Managed setup & validation support
Dedicated account manager & implementation support
Supports: 21 CFR Part 11, ISO 13485, ISO 9001, Custom

Best for: established organizations requiring custom compliance solutions and dedicated support.

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Built for Regulated Teams

SOC 2–certified infrastructure

Hosted on SOC 2–certified infrastructure providers with enterprise-grade security

Modern responsive design

Intuitive interface optimized for quality teams

Template-based guidance

Pre-built templates and workflow automation

Continuous platform updates

Regular feature releases and security updates

Feature Comparison

FeatureCoreScaleEnterprise
Electronic Signatures (21 CFR Part 11)
Document Control & Version Management
Change Control & CAPA Workflows
Role-based Access Control
Approval Workflow Automation
Comprehensive Audit Logging
Storage5 GB20 GBCustom
IQ/OQ Validation Package
OnboardingEmailDedicated CallManaged Setup
Dedicated Account Manager
Custom Compliance Consulting
Migration Assistance

Frequently Asked Questions

How do I get started?

We work with early-stage companies through a structured pilot process (typically 60-90 days). This gives you time to properly evaluate Tesseran with your real workflows and documents. Contact us to discuss your needs and set up a pilot.

Can I change plans later?

Plan changes can be made at your annual renewal. Contact us to discuss upgrading or changing your plan for the next contract period.

Is my data secure and compliant?

Yes. We use SOC 2–certified infrastructure providers with industry-standard encryption and logical data isolation per company. Our system is designed to support 21 CFR Part 11 requirements for electronic records and signatures.

What compliance standards do you support?

We include templates and workflows aligned to 21 CFR Part 11, ISO 13485, and ISO 9001 standards, with built-in templates and automated compliance tracking.

What if I need more storage?

Additional storage is $1/month per GB. You can add storage as your document library grows.

Is there a limit on users?

No. All plans include unlimited users, so you can add your entire quality team without worrying about per-seat costs.

Notes

Storage scaling: Need more space? Additional storage is $1/month per GB.

Data ownership: All plans include full exportability of your data — no lock-in.