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FDA record-keeping requirements

Manage records in accordance with FDA compliance requirements.

Long-term data retention that is trusted and proven

FDA requirements for preserving records related to clinical trials can be lengthy to say the least. HubStor helps you satisfy FDA compliance requirements cost efficiently, and at scale.

Preserve records with ease

Unlike do-it-yourself technologies that bog you down, HubStor delivers a simple, SOC 2-compliant Software-as-a-Service (SaaS) architecture, making it convenient for you to leverage a cloud data platform for FDA compliance. Request demo

Infinitely scalable

Billions of objects and petabytes after petabytes of data volume are no problem for HubStor.

Low-cost retention

Keep records on economic storage in the cloud to satisfy long-term retention without burdening your budget.

Policy engine

Leverage HubStor’s data management policy engine to classify records. Manage holds and retention. Track storage to studies and projects.

Create an FDA-compliance data lake

A data lake is the pooling of multiple disparate workloads into a centralized data management framework, giving you the ability to preserve the unique attributes of each data set but search, analyze, and manage globally with a common set of tools.

HubStor indexes and manages all workloads

The architecture of HubStor delivers a simple data platform for you to govern a wide spectrum of content types. Everything from email, SharePoint, backups, genomics, DICOM, databases, and more.

Protect your FDA compliance records

Radiology, digital pathology, studies with large numbers of files, DICOM images, device log files, email communications. HubStor modernizes storage and management of all unstructured data workloads to simplify FDA compliance.

Unified data management

Centrally manage content types in a specific manner with granularity under one unified system. HubStor’s flexible object-storage platform adapts to any type of unstructured data.

Mergers and acquisitions

Optimize mergers and acquisitions by securing information without delay. HubStor supports multiple directory providers so that identity and security can extend across all of your business entities.

Secure sharing

Provide a third-party secure access as needed. HubStor integrates with Azure Active Directory and includes link-based sharing with security management controls and auditing.

Legal hold & data governance

Manage litigation hold and sensitive compliance data. HubStor includes legal hold, search, cases, OCR, audio/video transcription, and custodian data mapping so that you can identify, preserve, and collect data for eDiscovery matters.

Put powerful discovery tools to use

Not only does HubStor deliver indexing at lightning speeds, but your search queries come back with results in the blink of an eye.

HubStor search features include:

  • Keywords, phrases, proximity, boosting, relevancy ranking, Boolean, and more.
  • Hit highlighting within a message preview pane.
  • Saved searches which can be shared amongst your team.
  • True custodian search across disparate workloads.
  • Place searches on legal hold and export when needed.

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SOC 2-compliant FDA compliance data platform

Security and compliance are top of mind for you and for us.

Enterprise-grade security stack

  • Multi-factor authentication.
  • IP whitelisting.
  • End-to-end encryption.
  • Vulnerability scanning.
  • Role-based access controls.

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Storing data for long periods doesn’t have to be painful

We’re helping life sciences, pharma, and medical device companies meet FDA compliance.

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