Bringing compliance expertise in-house with Compliance Intelligence, like Michael and the LogixX Pharma team did, lets your company easily prepare for audits without expensive ongoing or bespoke external consultancy support, saving significant time and effort from external QA reviewers.

The LogixX Pharma team estimates that Compliance Intelligence has saved them at least 1 FTE external QA expert, and months of time conducting gap analysis of their QMS system. Michael also pointed out that the external consultant gap analysis would only be as good as the training or knowledge that the external expert had received – which may not be relevant to your business. Compliance Intelligence removes compliance ambiguity with applied AI remedies.

Cutting weeks and months of manual work accelerates your company's strategic objectives, too, bringing ISO standard readiness forward by 80% and getting you ready to expand into new markets at speed.

And Compliance Intelligence ensures you don't only prepare for your audits faster, but pass them with confidence — and without regulatory fines, recalls or reputational damage.

Shielding your company from regulatory punishment is one of the best things you can do for your bottom line when you consider the average costs of compliance slip-ups in, for example, the United States:

• Cost of a Form 483 observation: $100-200K
• Cost of a warning letter: $50-250M
• Cost of an import alert: $150-500M
• Cost of a consent decree: $2B

The gap assessments and remediation recommendations provided by Compliance Intelligence are based on the expert-built, pre-validated frameworks that you have turned on within the tool.

Frameworks are the clause-by-clause requirement maps of the standards and regulations that matter to you.

From FDA 21 CFR Part 11 to ICH Q10, the QMSR and ISO 13485, just turn on a framework and Compliance Intelligence assesses your level of compliance with its requirements — so you can see at a glance which you’ve met, and what you
still need to do.

Audit preparation is only one of the many ways CI helps accelerate your compliance and product milestones!

Continuous compliance is a system of intelligence built not only to help you with point-in-time compliance events like audit preparation, but to help your organization be constantly compliance-ready. It does this by automating gap analysis and remediation, and proactively alerting you about compliance issues — and suggested resolution tasks. 

Here are the use cases that Compliance Intelligence is designed to address:

1. Built-in compliance: pre-built frameworks and controls 
2. Automated gap analysis: AI-powered assessment in minutes vs. weeks
3. Remediation management: Systematic management of compliance risks
4. Continuous observability: Real-time monitoring of compliance with total visibility for leadership