Controlled documents, audit trails and e-signatures for regulated life-sciences teams.

MedGuard is a document management suite for organizations that need HIPAA safeguards and 21 CFR Part 11 controls without an enterprise-scale implementation. It runs on Oracle Cloud Infrastructure, with an on-premise option for enterprise installs.

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Built for

Emerging biotechs
CROs
CMOs & CDMOs
Medical device companies
Clinical research sites

The suite

Three modules, one compliance foundation.

Start with document management. Add federated identity or on-premise licensing when you need them.

Document management

MedGuard-DMS

The core of the suite: a controlled document library with versioning, check-in and check-out, e-signatures, review workflows, retention schedules and an audit trail that can’t be edited.

Identity & access

MedGuard-IdP

Federated sign-in through SAML 2.0 or LDAP/Active Directory, time-based multi-factor authentication, and every sign-in event recorded in MedGuard’s audit logs. Available with MedGuard-DMS or on its own for other Oracle APEX applications.

Licensing

MedGuard-LC

License management for on-premise Enterprise installs. Each installation checks its license securely, with a grace period if the license service is briefly unreachable.

Capabilities

What inspectors look for, built in.

Document control

Major and minor versions, check-in and check-out, categories, templates and file checksums that flag any change made outside the system.

Electronic signatures

Signatures require password re-verification and record the signer, the date and time, and what the signature means.

Immutable audit trail

Every action is logged with who, what and when. Audit records can’t be changed or deleted.

PHI safeguards

Access to protected health information is logged with a stated reason. Emergency break-glass access is flagged for review, and uploads can be scanned for the 18 HIPAA identifiers.

Configurable workflows

Multi-step reviews and approvals, with task assignment, delegation and email notifications.

Retention & legal hold

Policy-based retention schedules, legal holds and destruction certificates.

Also included: full-text search, training records, expiring share links, compliance dashboards and reports, role-based access control, a REST API, and a multi-tenant architecture.

Deployment & validation

Run it where your data needs to live.

MedGuard is built on Oracle Database and Oracle APEX, so it fits naturally alongside existing Oracle investments.

Hosted on Oracle Cloud InfrastructureWe run and maintain it for you.
On-premise Enterprise EditionInstall it in your own environment, licensed through MedGuard-LC.
Validation supportDocumentation to support your computer system validation effort.
Implementation sized to youA defined implementation package instead of an open-ended consulting project.

Let’s scope MedGuard for your team.

Pricing is per user, with an implementation package matched to your size. Tell us about your organization and we’ll put together a quote.

Request a quote