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eCRF software system - why CRFweb?


CRFweb FDA 21 CFR 11 Compliance Audit

When choosing a system to help manage your clinical trial processes, security and compliance will likely be high on the list of things you want assurance about. At Clindox, security and compliance are matters we take very seriously and we've built our CRFweb system rigorously from the ground up to ensure we meet or exceed our compliance obligations... and our clients expectations. Compliance to FDA 21 CFR 11 is more than just a sentence in our marketing materials, it's an ongoing commitment to meet the highest standards.

The only way for a supplier of a trial software solution to demonstrate they have met their compliance requirements is to conduct an independent audit. We'd recommend any potential purchaser of any trial system to ask for evidence of a recent audit and consequently we're happy to share the results of ours here.

Our latest audit was undertaken in 2017 by specialist FDA 21 CFR 11 auditor R.D. McDowell Ltd. The audit included reference to the latest draft FDA guidelines on electronic records and signatures released in June 2017. It also included reference to EU GP Annex 11, regarding hosting and infrastructure. The audit found that "Clindox software is compliant with FDA 21 CFR 11 technical controls" , specifically:

If you'd like to see a copy of the full audit, just give us a call. For the latest draft guidelines on the use of electronic records and signatures under 21 CFR part 11 click here

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CRFweb is a Clindox application

CRFweb is fully compliant with and a Gold Member of the
Clinical Data Interchange Standards Consortium