Atlas FAQ: Common Questions from Pharma QA Teams

FDA enforcement is accelerating. FY2025 saw 694 more inspections than FY2024, and H2 2025 alone produced 327 warning letters, a 73% increase. Pharma and medical device quality teams evaluating Atlas tend to ask the same ten questions. Here are direct answers.

1. What Is Atlas?

Atlas is an FDA inspection and enforcement intelligence platform for pharma and medical device quality teams. It gives teams complete, current FDA data, structured and searchable for their specific use case:

• 700,000+ FDA inspections since 2010
• 30,000+ Form 483s and EIRs
• 11,828 warning letters since 2008
• ~500 Complete Response Letters (CRLs)
• 6,000+ investigator reports with focus areas and citation patterns
• Custom alerts via email or WhatsApp
• International agency data: MHRA, PMDA, Health Canada, CDSCO, Swissmedic

If Atlas doesn't have the data you're looking for, nobody does.

2. Who Uses Atlas?

Atlas is built for quality teams at pharma and medical device companies:

• VP Quality, Head of Site Quality, Chief Quality Officers, Directors of Corporate Quality
• Regulatory affairs teams
• Supplier and external manufacturer quality managers
• Internal audit and training leads

Customers include J&J, Kenvue, Bayer, Zydus, Cipla, Grifols, Natco, Alembic, Strides, and dozens more.

3. What Problems Does It Solve?

Quality teams typically struggle with:

• FDA data scattered across PDFs, spreadsheets, and tribal knowledge
• No visibility when a supplier or peer gets inspected
• Expensive, rigid, predetermined reports from legacy platforms
• Investigator patterns that shift year over year and are hard to track

Atlas addresses all four with complete data, custom analytics built for your exact use case, proactive alerts on any monitored entity, and 6,000+ investigator reports.

4. How Is Atlas Different from Other Platforms?

Three differentiators vs. the legacy alternative:

1. Fresher data. Inspection records typically arrive on Atlas within a business week, through proprietary market intelligence, before they appear on the FDA website or competing platforms.
2. More customizable. Atlas builds custom analytics rapidly for your exact use case, at no extra cost. Predetermined reports are the legacy model.
3. More accessible. Named user annual subscription licenses make inspection intelligence available to companies that previously couldn't justify enterprise pricing.

Built by ex-Google engineers. Activates with a click, no implementation project.

5. What Data Is in Atlas?

• Form 483s and EIRs: 30,000+ since 2010
• Warning letters: 11,828 since 2008
• Complete Response Letters (CRLs): ~500, updated continuously
• Import alerts, recalls, debarment letters
• Inspection histories across companies, sites, investigators, and countries
• Observations: 100,000+ searchable
• Investigator reports: 6,000+ with focus areas and citation patterns
• International data: MHRA, PMDA, Health Canada, CDSCO, Swissmedic

Every document is AI-tagged by keyword, CFR code, and observation category, and searchable in under 1 second.

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6. How Fresh Is the Data?

New inspection data typically arrives on Atlas within a business week of an inspection occurring, through proprietary market intelligence. That's before it's on the FDA website.

Teams get email or WhatsApp alerts when:

• A supplier or external manufacturer gets inspected
• A peer company receives a 483 or warning letter
• A specific investigator is active in a region of interest

7. How Secure Is Atlas?

• ISO 27001: Obtained
• Cybersecurity insurance: Obtained (required by customers like BMS and Thermo Fisher)
• SOC 2: In progress (Q2-Q3)
• Hosted on Azure
• Role-based access controls and audit logging

8. Can Atlas Help During an FDA Inspection?

Atlas's primary value is in the preparation phase, but it supports inspection response too:

• Research how similar observations were handled at peer companies
• Benchmark CAPAs against actual enforcement outcomes
• Surface the assigned investigator's complete inspection history, focus areas, and citation patterns
• Compare your site's inspection frequency and outcomes against peers

One customer ran a manual gap assessment and found zero gaps. Atlas found 100.

9. What's Onboarding Like?

Atlas activates with a click. No implementation project, no onboarding team, no setup fees. Cost to serve is effectively zero.

Feature requests go directly to the engineering team. No account managers, no support tiers. Engineers pick up the phone.

10. What's the Pricing and ROI?

Atlas uses named user annual subscription licenses. Typical range: $30K-$80K depending on company size and geography. That's a fraction of the legacy alternative, which runs $300-500K for enterprise deals.

Return on investment comes from:

• Faster inspection preparation: Hours of manual document hunting replaced with sub-second search
• Better CAPAs: Grounded in actual enforcement data, not guesswork
• Supplier visibility: Catch a supplier's 483 before it disrupts your supply chain
• Benchmarking: Know what the FDA is citing at companies like yours

Want to see how Atlas fits your situation? Book a demo and we'll walk through your exact use case.