QualiVault

QualiVault is a web-based document-control product for medical device, biotech and pharma teams. It suits regulated teams that need approvals, signatures and audit trails in one place; its free tier makes a small-scale start possible, but strict seat and storage caps quickly narrow its reach.

Overview

QualiVault brings document versioning, review cycles and effective dates together with approval workflows, electronic signatures and role-based access. Its focus on regulated life-sciences work is a strength for teams managing controlled documents, rather than a reason to choose it for general-purpose file storage.

The product states that it supports 21 CFR Part 11 compliant electronic records and signatures, with verified user identities and tamper-evident audit trails. It also says documents are encrypted at rest and in transit, actions are recorded in an immutable audit trail, and its infrastructure uses isolated tenancy. These safeguards speak to compliance and traceability needs, though the stated support should not be mistaken for a blanket compliance guarantee.

Key features

• Document control: Versioning, review cycles and effective-dating help teams maintain controlled document lifecycles instead of relying on informal file handoffs.
• Approvals and training: Automated notifications cover approvals, periodic reviews and training, which can help teams keep recurring responsibilities visible.
• Audit and reporting: One-click compliance reports assemble inspection-ready packets for FDA inspections and ISO audits. That is a practical fit for teams preparing records, while the product’s audit trail records actions for traceability.
• Permissions: Separate roles for authors, reviewers, approvers and observers support a clearer division of responsibility than undifferentiated access.
• Integrations and migration: QualiVault says it connects with customers’ document sources and identity providers, with specific integrations buildable during standard onboarding.

Pricing

QualiVault uses a freemium model, with monthly paid plans and no free trial. The free tier is perpetual and requires no credit card, but its 2-seat hard cap and 50 KB of document storage make it more suitable for a very limited evaluation or tiny document set than ongoing team use. Community support is the included support option.

• Free — free: 2 seats (hard cap) and 50 KB storage. Choose it to start without a subscription; the storage ceiling is the main constraint.
• Basic — $9.99 a month: 2 seats (hard cap), 5 GB storage and email support. It adds meaningful storage over Free without expanding the team beyond two people, so it fits a small operation that can work within that cap. It is billed monthly and can be cancelled anytime.
• Plus — $29.99 a month: 3 seats included and 25 GB storage, with additional seats at + $6.99 per seat and phone support. This is the first tier that gives a small team more than two seats.
• Pro — $49.99 a month: 5 seats included and 100 GB storage, with additional seats at + $6.99 per seat and priority support with an account manager. It is the stronger fit for teams needing more room and a higher-touch support channel.
• Enterprise — custom pricing: For teams over 50 seats or organizations needing dedicated tenancy, custom DPAs or invoiced annual billing. It addresses larger or more specialized deployments, but requires a pricing conversation.

All named paid plans are billed monthly. The important trade-off is that Free and Basic remain capped at two seats; growing beyond that means stepping up to Plus or Pro, or paying per additional seat on those plans.

Platforms

QualiVault is available on the web. Teams looking specifically for a native mobile or desktop platform should consider that limitation before choosing it.

Who it's for

QualiVault is aimed at life-sciences teams in medical device, biotech and pharma companies that need controlled documentation, defined approval roles and inspection-oriented records. Its founders say they previously built and shipped an FDA-regulated medical device, a background aligned with the product’s regulated-industry focus.

Pros and cons

• Pro: Versioning, review cycles, effective dates, signatures and audit trails are brought together for controlled-document workflows.
• Pro: One-click compliance reports target FDA inspection and ISO audit preparation, reducing the need to assemble packets manually.
• Pro: A perpetual free tier with no credit card gives teams a low-commitment way to begin.
• Con: Free and Basic both stop at 2 seats, making them poor fits for even modestly larger teams.
• Con: Free’s 50 KB storage cap is exceptionally restrictive for a document-control product; meaningful document use calls for a paid tier.
• Con: Web is the only supported platform, and no free trial is offered.

Alternatives

For a broader category comparison, see Document Control Software.

• GatesFlow QMS is worth considering if a free trial or API access matters; its free plan is described as having generous usage limits for individuals or small teams, with paid plans starting at $20 a month.
• Ketryx offers a free plan and web access, with Startup for organizations under 200 people and a Business tier for scaling companies; consider it when that company-size framing suits your needs.
• AssurX Document Management is a paid option with web, mobile, API and self-hosted platforms; consider it if those deployment choices matter more than a free plan.
• IQVIA SmartSolve Complaint Management is a paid web and mobile product; consider it if complaint management is the specific need.
• Qontiv is a paid option with API, Linux, web and Windows platforms and a $1,000/mo platform fee plus graduated per-line monthly rates; its stated pricing makes it a substantially different cost model.
• QT9 QMS offers a free trial, annual licensing and cloud or self-hosted deployment; consider it if those terms or deployment options are a priority.
• TrackWise Digital has a QuickTrack offering designed for startups and small and medium businesses, alongside a QMS Suite; consider it if you want to compare those two product scopes.
• Veeva Network MDM is positioned for enterprise pharma, biotech, animal health and consumer health, with 100+ customers; consider it for that enterprise MDM context.

Verdict

QualiVault is a sensible choice for a life-sciences team that needs web-based document control with approvals, signatures, traceable actions and inspection-oriented reporting. Its regulated-workflow focus is the central reason to choose it. Look elsewhere if your team needs mobile or desktop access, or if the two-seat entry plans and small free storage cap do not match your scale.