Quality management for pharma & biotech, audit-ready in weeks
FDA 21 CFR Part 11, ICH Q10, GAMP 5. All modules included.
The spreadsheet QMS
You're tracking deviations in Excel, training records in a shared drive, and document approvals via email. It works - until the auditor asks for your audit trail.
- Document versions scattered across SharePoint and email
- Training records that can't prove who was trained on what
- CAPA processes that exist on paper but not in practice
This is how most pre-commercial companies start. It's also why first audits fail.
The enterprise overkill
Enterprise QMS platforms are built for 500-person pharma companies. They take 6 months to implement, cost $200K+/year, and require a dedicated admin team you don't have.
- 3-6 month implementation before your first audit deadline
- Per-module pricing that doubles the cost by the time you add training
- Configuration complexity that requires consultants to set up
You need something between a spreadsheet and an enterprise platform.
Complete QMS
Every module you need for GxP compliance
All included. No per-module upselling.
Document control
Version management, digital signatures, SOP lifecycle. 21 CFR Part 11 compliant.
CAPA management
Corrective and preventive actions with root cause analysis and effectiveness checks.
Training management
Training records, competency tracking, automatic assignment when documents change.
Change control
Change requests with impact assessment, approval routing, and implementation tracking.
Audit management
Internal and external audit workflows, finding tracking, evidence collection.
Complaint management
Complaint intake, investigation, regulatory reporting workflows.
QMS buyer's checklist
Validation requirements, feature evaluation matrix, deployment questions, and total cost of ownership - in one checklist.
Compliance cost benchmarks
Cost-per-employee benchmarks, spend breakdowns by category, and reduction targets across regulated industries.
How it works
Audit-ready in 21 days
Not a sandbox. Your QMS, configured and live.
1
Discovery
We learn your product, your stage, and your audit timeline. Map which modules you need now vs. later.
Week 1
2
Configuration
Your document types, workflows, user roles, and approval chains configured in the system. Validation documentation included.
Weeks 2-3
3
Go-live
Working QMS recording your quality activities. Your team trained. Ready for your auditor.
Day 21
Your QMS before your deadline
Most pre-commercial companies need their QMS operational 3-6 months before their first audit. The sooner you start recording quality activities, the stronger your audit evidence.
Built to grow
Right-sized today, extensible tomorrow
Start with the QMS you need now. When your operations outgrow standard modules, the platform extends.
Custom workflows
When you need a process your QMS doesn't have a template for, build it. Same system, same audit trail.
Self-hosted option
Run on your own infrastructure. Full data sovereignty for GxP environments. Unique among QMS challengers.
19 years of platform heritage
Built on a process automation platform refined since 2007. Not a startup experiment - production-hardened infrastructure.
Trusted by companies across regulated industries, read full customer stories
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