FileTrail's Qualifications

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21 CFR Part 11 Audit

A global pharmaceutical company conducted a formal audit for compliance with 21 CFR Part 11 to allow users to comply with predicate rules and document compliance, prior to contracting with FileTrail.

21 CFR Part 58 Audit

A global clinical outsourcing company conducted a formal audit of processes and operating procedures at our headquarters in San Jose prior to contracting with FileTrail .

Tier 1 Cloud Audit

The Tier 1 Cloud platform has undergone SSAE 16 (SOC 1 and SOC 2) audits and are certified according to ISO/IEC 27001. 

SME Cloud Audit

The SME Cloud platform has undergone Type II SSAE 16 certification and has been formally audited by a global pharmaceutical company.

IBM Rational AppScan

A 3rd-party audit was conducted by IBM using Rational AppScan for a global insurance company prior to contracting with FileTrail to evaluate the software for defects in security.

Secure DNA Scan

A 3rd-party audit was conducted by Secure DNA (secure-dna.com) for a large educational institution prior to contracting with FileTrail to evaluate the software for defects in security.

QA/QC Validation

A formal QA/QC Validation was performed by a leading pharmaceutical company prior to a global implementation spanning the US and Europe.  Three additional pharmaceutical companies have since conducted formal Validations prior to implementation.

Continuous Security Monitoring and Updates

All FileTrail software releases are scanned with Acunetix Web Vulnerability to ensure the highest standards for application security have been met prior to release.