Quality, Redefined

The QMS built for how life sciences actually works

Document control, CAPA, deviations, training, and audit management in one platform. Purpose-built for biotech, pharma, and CROs.

$6B+

Global QMS market (2025)

21 CFR 11

FDA compliant by design

Weeks

Not months to audit-ready

The Problem

Legacy QMS tools were built for yesterday's pharma. You're building tomorrow's biotech.

6-month implementations

Enterprise QMS platforms require armies of consultants and half a year before your first document is controlled. Startups can't wait that long.

Built for manufacturers, not CROs

Multi-sponsor studies, cross-site quality events, parallel audit tracks. No legacy QMS handles the way CROs actually operate.

$50K-$200K/year pricing

Enterprise pricing locks out the biotech startups and growing CROs that need quality systems the most. Compliance shouldn't be a luxury.

Quality management that moves at the speed of science

Protocura combines deep regulatory intelligence with modern cloud architecture. Every workflow, every template, every audit trail is designed for the unique demands of life sciences companies.

Document Control

Version-controlled SOPs, protocols, and regulatory documents with electronic signatures, full audit trails, and automated review cycles.

FDA 21 CFR Part 11

CAPA Management

Track corrective and preventive actions from initiation through effectiveness checks. AI-suggested root causes based on your historical quality data.

ICH Q10 Aligned

Deviation Tracking

Capture, classify, and resolve deviations with configurable workflows. Auto-escalation rules ensure nothing falls through the cracks during critical studies.

GxP Ready

Training Management

Role-based training assignments tied directly to document revisions. Demonstrate operator qualification across facilities and sponsor requirements.

ISO 13485

CRO-native from day one

The first QMS designed around how contract research organizations actually manage quality across sponsors, studies, and sites.

Multi-Sponsor Control

Separate document hierarchies and quality events per sponsor while maintaining your organizational QMS layer.

Sponsor Audit Ready

Generate sponsor-specific audit packages instantly. No more scrambling before client QA visits.

Cross-Site Quality

Unified quality events across multiple research sites with site-level permissions and global oversight dashboards.