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What are the FDA Regulations for Use Of Electronic Records in Clinical Investigations, and how is compliance determined?

The FDA Regulations for Use of Electronic Records in Criminal Investigations are codified in 21 CFR Part 11, and cover the types of measures that organizations should take to protect electronic data while conducting FDA-regulated clinical trials for medical products under investigational new drug applications (INDs). It applies to institutional review boards (IRBs), contract research organizations (CROs), clinical investigators, sponsors and other organizations conducting FDA-regulated trials involving human drugs, biological products, medical devices and combination products.

To comply, organizations will need to incorporate data access controls, audit devices, use experienced and trained records security professionals, incorporate time-stamped audit trails, and use controls to protect the accuracy and integrity of their digitized clinical trial data. Entities that store their data on systems outside their direct control must also use document encryption and digital signature standards where necessary. You can learn more about these requirements here.

How does hosting for the FDA Regulations for Use Of Electronic Records in Clinical Investigations work?

Abacus Private Cloud can help you fulfill your FDA compliance goals by helping you host your clinical trial data in the cloud.  Our virtual cloud hosting platform boasts three levels of physical, server and data security, and allows you to host your data and run software on in an ePHI and HIPAA-compliant environment that features 256-bit AES encryption, 2FA, dedicated IP addresses and other industry-standard safeguards.  Our hosting team will help you safely migrate your data onto our SSL-A-rated server network and configure your account to meet FDA records security regulations.

How can I audit and maintain compliance with FDA Regulations for Use Of Electronic Records in Clinical Investigations?

Fortunately, you won’t need to worry about this!  Our team of experienced FDA electronic records hosting experts will audit your Private Cloud accounts using FIPS, NIST and SSAE-16 SOC-level compliance standards.  They’ll also automate software updates, patch potential vulnerabilities and provide around-the-clock support for your FDA compliance needs. 

Are there Abacus Private Cloud clients who are compliant with the FDA Regulations for Use Of Electronic Records in Clinical Investigations today?

Yes! Contact us to see how Abacus Private Cloud can help you meet your FDA compliance goals.

Additional Resources

  1. 21 CFR Part 11