QualiVault
qualivault.com
What it is
QualiVault is web-based document control software for medical device, biotech, and pharma teams. It supports document versioning, review cycles, and effective-dating, with permissions for authors, reviewers, approvers, and observers. Automated notifications cover approvals, periodic reviews, and training, while one-click reports assemble inspection-ready packets for FDA inspections and ISO audits. The product states that it supports 21 CFR Part 11 compliant electronic records and signatures, verified user identities, and tamper-evident audit trails. Its maker says documents are encrypted at rest and in transit, actions are recorded in an immutable audit trail, and infrastructure uses isolated tenancy. QualiVault offers a perpetual free tier with a hard cap of two seats and 50 KB of document storage. Basic costs $9.99 a month and includes two seats and 5 GB; Plus costs $29.99 a month with three seats included and 25 GB; Pro costs $49.99 a month with five seats and 100 GB. Enterprise pricing is by contact.
Spec sheet
- What it does
- QualiVault is a document-control and quality-management service aimed at medical-device, biotechnology and pharmaceutical teams.Read 14 Oct 2026 · qualivault.com
- Purpose
- QualiVault provides document control for medical device, biotech, and pharma teams.Read 5 Oct 2026 · qualivault.com
- Integrations
- QualiVault says it connects to customer document sources and identity providers and can build requested integrations during onboarding.Read 14 Oct 2026 · qualivault.com
- Security
- The maker says documents are encrypted at rest and in transit, actions are recorded in an immutable audit trail, and its infrastructure uses isolated tenancy.Read 5 Oct 2026 · qualivault.com
- 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.Read 5 Oct 2026 · qualivault.com
- Support
- Support ranges from community assistance on Free to email, phone, priority service and a dedicated account manager on higher tiers.Read 14 Oct 2026 · qualivault.com
- Access controls
- Role-based permissions are available for authors, reviewers, approvers, and observers.Read 5 Oct 2026 · qualivault.com
- API and SDK availability
- The official pages opened describe integrations but provide no public API reference, SDK download or developer portal.Read 14 Oct 2026 · qualivault.com
- Approval workflow
- Controlled documents can move through author, reviewer, approver and observer roles.Read 14 Oct 2026 · qualivault.com
- Audit trail
- Every action is recorded in a signed, tamper-evident audit trail.Read 14 Oct 2026 · qualivault.com
- Company background
- The founders say they previously built and shipped an FDA-regulated medical device.Read 5 Oct 2026 · qualivault.com
- Company legal name
- The website footer identifies the business as QualiVault LLC.Read 14 Oct 2026 · qualivault.com
- 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.Read 14 Oct 2026 · qualivault.com
- Document control
- The system provides document versioning, review cycles and effective dates.Read 14 Oct 2026 · qualivault.com
- Documentation depth
- The official site contains marketing pages, pricing FAQs and contact support but no linked technical documentation or help center was shown.Read 14 Oct 2026 · qualivault.com
- Electronic signatures
- Electronic approvals are presented as compliant with FDA 21 CFR Part 11 and require no plug-in.Read 14 Oct 2026 · qualivault.com
- Founder background
- The About page says the founders previously built and shipped an FDA-regulated medical device.Read 14 Oct 2026 · qualivault.com
- Free-tier behavior
- The Free tier is permanent, has no trial countdown or automatic upgrade, and keeps data accessible after cancellation within its limits.Read 14 Oct 2026 · qualivault.com
- Getting started
- The company says teams commonly upload their first controlled document within an hour of signup.Read 14 Oct 2026 · qualivault.com
- Headquarters and founding year
- The About page does not state a headquarters or founding year.Read 5 Oct 2026 · qualivault.com
- 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.Read 14 Oct 2026 · trustradius.com
- Licence
- The official pages opened do not state an open-source licence or publish source code.Read 14 Oct 2026 · qualivault.com
- Limit: enterprise pricing
- Organizations needing more than 50 seats, dedicated tenancy or custom DPAs must request Enterprise pricing.Read 14 Oct 2026 · qualivault.com
- Limit: entry seats
- Free and Basic accounts cannot exceed two seats without moving to Plus or Pro.Read 14 Oct 2026 · qualivault.com
- Limit: entry storage
- The Free plan allows only 50 KB of document storage, while Basic allows 5 GB.Read 14 Oct 2026 · qualivault.com
- Limit: feature gating
- Role-based access and one-click compliance reports begin at Plus, while training and supplier management begin at Pro.Read 14 Oct 2026 · qualivault.com
- Migration
- The maker says it performs hands-on migration while retaining legacy document structure.Read 14 Oct 2026 · qualivault.com
- News
- No dated QualiVault press release or launch announcement was found in the opened web results; the site itself is copyright-marked 2026.Read 14 Oct 2026 · qualivault.com
- Notifications
- Automated alerts cover approvals, periodic document reviews and training events.Read 14 Oct 2026 · qualivault.com
- Payment
- Cards are processed through Stripe; Pro and Enterprise customers can arrange ACH or invoiced billing.Read 14 Oct 2026 · qualivault.com
- Platform evidence
- The maker links users to app.qualivault.com for login and signup, indicating browser access; no desktop or mobile download is linked.Read 14 Oct 2026 · qualivault.com
- Rating on Capterra
- The opened Capterra pages show other products named Vault and SkuVault; no QualiVault rating or review count is displayed.Read 14 Oct 2026 · capterra.com
- Rating on G2
- No QualiVault rating or review count is displayed on the opened G2 comparison directory page.Read 14 Oct 2026 · g2.com
- Rating on Gartner Peer Insights
- No QualiVault rating or review count is displayed in the opened Gartner Peer Insights market directory.Read 14 Oct 2026 · gartner.com
- Rating on TrustRadius
- No QualiVault rating or review count is displayed on the opened TrustRadius directory homepage.Read 14 Oct 2026 · trustradius.com
- Reporting
- One-click compliance reports are intended to create packets for FDA, ISO 13485 and ISO 9001 audits.Read 14 Oct 2026 · qualivault.com
- Security encryption
- The service states that documents are encrypted both while stored and while transmitted.Read 14 Oct 2026 · qualivault.com
- Security tenancy
- The maker describes hardened cloud infrastructure with isolated tenancy and immutable action logging.Read 14 Oct 2026 · qualivault.com
- Self-hosting
- The product is presented as a hosted cloud service and the official pages opened do not describe a self-hosted deployment.Read 14 Oct 2026 · qualivault.com
- Supplier management
- Supplier features include quality-supplier lists, scorecards and approval workflows.Read 14 Oct 2026 · qualivault.com
- Training records
- Training assignments and verification against controlled documents are included in the capability list.Read 14 Oct 2026 · qualivault.com
- Who it is for
- QualiVault describes its intended customers as life sciences teams, including medical device, biotech, and pharma companies.Read 5 Oct 2026 · qualivault.com
- Workflow
- Automated notifications cover approvals, periodic reviews, and training.Read 5 Oct 2026 · qualivault.com
Plans and prices
Free Free Perpetual free tier · No credit card 2 seats hard cap · 50 KB document storage · document control · audit trail · basic reporting · 21 CFR Part 11 Read 14 Oct 2026 · qualivault.com
Basic $9.99 a month Billed monthly · Cancel anytime 2 seats hard cap · 5 GB storage · Free features · email support Read 14 Oct 2026 · qualivault.com
Plus $29.99 a month Billed monthly · $6.99 per additional seat 3 seats included · 25 GB storage · role-based access · advanced reporting · compliance reports · email notifications · phone support Read 14 Oct 2026 · qualivault.com
Pro $49.99 a month Billed monthly · $6.99 per additional seat 5 seats included · 100 GB storage · advanced analytics · training management · supplier management · priority support · dedicated account manager Read 14 Oct 2026 · qualivault.com
Enterprise Priced on request Contact for Enterprise pricing Over 50 seats · dedicated tenancy · custom DPAs · invoiced annual billing Read 14 Oct 2026 · qualivault.com
Strong points and limits
Strong points
- Includes versioning, review cycles, and effective-dating.
- Role permissions distinguish four document roles.
- Free tier has no credit card requirement.
- Migration preserves document structure, according to the company.
Limits
- Free tier is capped at two seats.
- Free storage is limited to 50 KB.
- No free trial is offered.
- Enterprise pricing is by contact.
Who it suits
QualiVault suits life sciences teams that need document controls, approval processes, audit trails, and electronic signatures. Its listed controls and reports address medical device, biotech, and pharma organizations preparing for FDA inspections or ISO audits.
Verdict
QualiVault lays out document controls, compliance features, security claims, and multiple seat and storage limits. Teams should compare those limits with their needs and confirm specific integrations during onboarding.
Where Specifiction places it
- Document Control Software#6 of 268.3