Early Access — Join the Waitlist

The Only QMS Designed
by a Former FDA Investigator

Most QMS software is built by software companies. Drua QMS was built by someone who spent years on the other side of the inspection — and knows exactly what FDA looks for.

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Inspection-Ready by Design
Built around what FDA investigators actually scrutinize — not just what the regulations say on paper.
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Validated. On Day One.
Full IQ/OQ/PQ documentation is included. You don't validate it — we already did.
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Expert Support, Not a Help Desk
When you have a regulatory question, you reach Victoria — not a ticket queue.
ISO 13485:2016 21 CFR Part 11 21 CFR Part 820 / QMSR EU MDR 2017/745 ISO 14971:2019 GAMP 5 Category 4 AWS SOC 2 Type II FIPS 140-2 Level 3
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What's included

20 Regulatory Modules

Everything your quality system needs, pre-built and pre-validated.

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Document Control
ISO 13485 §4.2
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CAPA
820.100 / §8.5
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Nonconformance
820.90 / §8.3
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Training Records
820.25 / §6.2
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Internal Audits
820.22 / §8.2.2
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Complaint Handling
820.198 / §8.2.1
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Supplier Management
820.50 / §7.4
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Risk Management
ISO 14971:2019
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Design Controls
820.30 / §7.3
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Change Control
820.70 / §4.2
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Management Review
820.20 / §5.6
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E-Signatures
21 CFR Part 11
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Audit Trail
Part 11 §11.10(e)
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Equipment Calibration
820.72 / §7.6
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Labeling Control
820.120
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Field Actions / Recall
820.160 / §8.5.4
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MDR / Vigilance
820.198 / IVDR
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Access Control
Part 11 §11.10(d)
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DHF / DMR
820.181 / 820.184
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Post-Market Surveillance
EU MDR Art. 83

Built for regulated environments

Enterprise-Grade Infrastructure

Designed and validated to meet FDA and international regulatory expectations.

Hosting AWS (EC2, RDS PostgreSQL, S3) SOC 2 Type II certified infrastructure
Data Encryption AES-256 at rest & in transit AWS KMS customer-managed keys, FIPS 140-2 Level 3
Authentication JWT + TOTP MFA bcrypt hashed, 30-min session timeout, session revocation
Audit Trail INSERT-only, SHA-256 hash chain 5-year retention, tamper-evident, Part 11 §11.10(e)
Tenant Isolation Architecturally enforced JWT-injected tenant context on every query
Validation Status IQ / OQ / PQ per GAMP 5 Full validation documentation available on request

Limited early access

Be First in Line

Drua QMS is in final validation. Join the waitlist and get early access, launch pricing, and a personal walkthrough with Victoria.

→ Early access before public launch
→ Launch pricing for waitlist members
→ Personal walkthrough with Victoria

No spam. Early access and launch pricing only.