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Compliance

CARA is a content and information management platform that provides the tools to help you build systems to meet compliance requirements in a variety of areas including GDPR, 21 CFR Part 11 / EU Annex 11, SOX, eCTD, FCPA and HIPAA.

We help you streamline your processes in order to reduce cost and improve efficiency.

Regulatory Compliance made easy.

Whether you face industry-specific compliance requirements such as 21 CFR Part 11 and EU Annex 11 or HIPAA, or more general ones such as FCPA, SEC, SOC2 or ISO, you need a system that will provide the tools for being able to meet and prove your compliance.

CARA has easy-to-configure auditing and very granular security, allowing full traceability of document creation, review / approval, and consumption, including electronic signatures or digital signatures with AdobeSign / DocuSign. Additionally there are fully configurable workflows with automatic reminders and system-triggered start dates to force a particular business process to be followed, and rich reporting to show not just what documents and data you have that proves compliance, but more importantly what artifacts might be missing.

Ensuring compliance of data structures, security and traceability are common themes across a variety of regulations and industries.

CARA’s flexible security model ensures conditional access control and system rights, which enables compliance and traceability at a detailed level. With our secure audit trail and version control, you can also track and report who did what in the system and when, and supplement it by capturing and displaying electronic signatures.

We have pre-configured settings in CARA to meet many common requirements in the industries within which we specialise.

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