How Sentec cut audit prep by 80% with Compliance Intelligence

An enterprise medical device team reduced audit prep from one week to one day and gained 360° visibility across their QMS

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"CI gives us a 360° view and surfaces gaps automatically. We resolve issues faster.

Christophe Sentec
Christophe Dohr
Site Quality Manager, Sentec
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The results

Audit prep at 5x speed 

 

Compliance Intelligence gave Sentec the visibility and productivity they needed for total audit confidence.

 

Activity Before Compliance Intelligence After Compliance Intelligence
Audit prep 1 full working week (5 days) of preparation per audit 1 day — an 80% reduction
Quality team focus Time spent manually searching for gaps Time redirected to fixing gaps and continuous improvement; event throughput speed accelerated

 

 

"CI surfaces gaps automatically. We resolve issues faster and walk into audits with confidence.

— Christophe Dohr, Site Quality Manager, Sentec

 

Talk to an expert

Setting
How it works

Manually policing the Sentec QMS to look for improvement opportunities and potential audit findings took the team hours of manual work each week.

Compliance Intelligence’s AI-supported gap analysis process took just 40 minutes to perform an entire scan of Sentec’s QMS, from SOPs to policies and records, before delivering a detailed breakdown of every single compliance gap, along with remediation reommendations to close them.

 

CI gap detection example

 

By letting Compliance Intelligence find and flag compliance gaps for them, Sentec's quality team could spend extra time on continuous improvement which wasn’t available before.

For example, Compliance Intelligence flagged 2 improvements for Sentec’s CAPA and non-conformance management processes, suggesting tighter step ownership and more clearly defined timelines. The team responded by introducing RACI metrics and more detailed event step explanations.

The team noticed that this reallocation of effort from ‘spotting’ to ‘fixing’ boosted productivity, allowing quality manpower to be redirected to close out events faster and cut throughput time.

"Compliance Intelligence reduces our risk and is a state-of-the-art tool for proactive compliance.

— Christophe Dohr, Site Quality Manager, Sentec

 

The quality team also pinpoints dramatic time savings in audit preparation delivered by Compliance Intelligence.

The tool’s automated gap analysis and remediation recommendations removed the bulk of manual audit prep activity for the Sentec team, cutting audit prep time by 80% from a full week to just a single day.

 

System scan of entire QMS (1)

 

FAQs

How does Compliance Intelligence know what to assess our QMS for?

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.

What's the return on investment of preparing for audits faster?

Freeing your quality team's time from manual gap assessment and redirecting it to proactive, continuous improvement has significant financial impact. Cutting 80% of audit prep time, like Sentec did, gives your team more time to improve processes, close gaps, and stamp out audit findings before your auditor ever spots them.

Bringing compliance expertise in-house with Compliance Intelligence also lets your company prepare for audits without consultancy support, saving, on average, $150–$300K per year.

Compliance Intelligence ensures you don't only prepare for your audit at speed, but pass it 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:

  • 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

We already pass all of our important audits for the year and our QMS is in good shape. What would I need Compliance Intelligence for?

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
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About Sentec
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Headquarters
—Landquart, Switzerland
User
Size
—201-500
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Industry
—Medical device

Sentec is a Swiss-American medical device company specializing in respiratory care and non-invasive monitoring.

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