- Home
- Document Control Software
- QualiVault
QualiVault
What it is
QualiVault is a web-based document control service for medical device, biotech, and pharmaceutical teams. It manages document versions, review cycles, and effective dates, with role-based permissions for authors, reviewers, approvers, and observers. Automated notifications cover approvals, periodic reviews, and training. The product states that it supports 21 CFR Part 11-compliant electronic records and signatures, with verified identities and tamper-evident audit trails. One-click compliance reports assemble packets for FDA inspections and ISO audits. QualiVault says documents are encrypted at rest and in transit, actions are recorded in an immutable audit trail, and its infrastructure uses isolated tenancy. It also says it can connect to customers’ document sources and identity providers, with specific integrations built during standard onboarding, and offers migration that preserves document structure. A free plan is available, with Basic at $9.99 a month, Plus at $29.99 a month, and Pro at $49.99 a month. Enterprise pricing is by contact. Free and Basic cap seats at two; their listed storage is 50 KB and 5 GB respectively.
For and against
For
- Tracks document versions, review cycles, and effective dates.
- Automates notifications for approvals, reviews, and training.
- Provides role-based permissions for four document roles.
- Free plan is available.
Against
- Free plan caps access at two seats.
- Free plan includes 50 KB of document storage.
- Enterprise pricing requires contacting the company.
- No free trial is listed.
The verdict
QualiVault combines document control, role permissions, notifications, and compliance reporting for life sciences teams. Compare the seat and storage limits of the listed plans with your needs before choosing.
Who it suits
QualiVault is intended for life sciences teams, including medical device, biotech, and pharma companies. Its document controls and inspection-report features may suit teams managing regulated records and approval processes.
Plans and prices
Free
2 seats hard cap · 50 KB document storage · document control · audit trail
Read 14 Oct 2026 · qualivault.com
Basic
2 seats hard cap · 5 GB storage · Free features · email support
Read 14 Oct 2026 · qualivault.com
Plus
3 seats included · 25 GB storage · role-based access · advanced reporting
Read 14 Oct 2026 · qualivault.com
Pro
5 seats included · 100 GB storage · advanced analytics · training management
Read 14 Oct 2026 · qualivault.com
Enterprise
Over 50 seats · dedicated tenancy · custom DPAs · invoiced annual billing
Read 14 Oct 2026 · qualivault.com
On the record
- Access controls
- Role-based permissions are available for authors, reviewers, approvers, and observers.qualivault.com · read 5 Oct 2026
- API and SDK availability
- The official pages opened describe integrations but provide no public API reference, SDK download or developer portal.qualivault.com · read 14 Oct 2026
- Approval workflow
- Controlled documents can move through author, reviewer, approver and observer roles.qualivault.com · read 14 Oct 2026
- Audit trail
- Every action is recorded in a signed, tamper-evident audit trail.qualivault.com · read 14 Oct 2026
- Company background
- The founders say they previously built and shipped an FDA-regulated medical device.qualivault.com · read 5 Oct 2026
- Company legal name
- The website footer identifies the business as QualiVault LLC.qualivault.com · read 14 Oct 2026
- Compliance
- The product states that it supports 21 CFR Part 11 compliant electronic records and signatures, with tamper-evident audit trails and verified user identities.qualivault.com · read 5 Oct 2026
- Compliance positioning
- QualiVault markets every plan, including Free, as 21 CFR Part 11 compliant and describes its architecture as HIPAA-ready and ISO 13485 friendly.qualivault.com · read 14 Oct 2026
- Documentation depth
- The official site contains marketing pages, pricing FAQs and contact support but no linked technical documentation or help center was shown.qualivault.com · read 14 Oct 2026
- Document control
- The system provides document versioning, review cycles and effective dates.qualivault.com · read 14 Oct 2026
- Electronic signatures
- Electronic approvals are presented as compliant with FDA 21 CFR Part 11 and require no plug-in.qualivault.com · read 14 Oct 2026
- Founder background
- The About page says the founders previously built and shipped an FDA-regulated medical device.qualivault.com · read 14 Oct 2026
- Free-tier behavior
- The Free tier is permanent, has no trial countdown or automatic upgrade, and keeps data accessible after cancellation within its limits.qualivault.com · read 14 Oct 2026
- Getting started
- The company says teams commonly upload their first controlled document within an hour of signup.qualivault.com · read 14 Oct 2026
- Headquarters and founding year
- The About page does not state a headquarters or founding year.qualivault.com · read 5 Oct 2026
- Independent-review coverage
- The opened G2, TrustRadius, Gartner and Capterra directory pages do not show a QualiVault product profile, so repeated independent praise or complaints could not be verified there.trustradius.com · read 14 Oct 2026
- Integrations
- QualiVault says it connects to customer document sources and identity providers and can build requested integrations during onboarding.qualivault.com · read 14 Oct 2026
- Licence
- The official pages opened do not state an open-source licence or publish source code.qualivault.com · read 14 Oct 2026