Home Solutions Inspection and enforcement intelligence Inspection intelligence. Activated. Inspection and enforcement intelligence When an inspection is a day or two away, you need the inspector’s history, your site’s full record, and the findings escalating right now. Inspection and Enforcement Intelligence (I&E Intelligence) pulls every inspection record and enforcement action into one place across seven health authorities, then turns it into the profiles, briefs, and reports your team needs to prepare. Book a meeting Why inspection readiness isn’t easy today The data is scattered Form 483s, warning letters, and enforcement records sit in separate, unlinked databases. Assembling one site’s history means matching documents by hand, across multiple authorities around the world. No time before an inspection Teams get one or two days’ notice, sometimes none. Without a ready inspector profile, prep means digging through dozens of PDFs. Inspector intelligence isn’t public No public database holds inspector histories. Finding who’s coming, and what they cite, means tracing signatures across hundreds of 483s yourself. Blind spots in China and Japan NMPA and PMDA records aren’t available in English anywhere else. For teams with sites or suppliers in Asia, that’s a real, unmanaged risk. Intelligence you can’t act on Most tools show you what happened, but they don’t help you respond. The gap from a finding to a corrective action stays manual and slow. I&E Intelligence that fits your role For GMP audit management For inspection readiness & QA For supply chain and vendor quality For site quality heads Audit what regulators are actually citing I&E Intelligence shows GMP audit managers what regulators are citing right now, across facilities, suppliers, and CMOs, so audits target current risk instead of last year’s checklist. Point your audit program at what regulators are citing now, by product type and authority Open any audit with the site’s full inspection and enforcement history in hand Turn audit findings into drafted CAPA and change-control actions, then track them to completion Stay current with regular summaries of recent citations and trends Know the inspector before the inspection When notice is short and a 483 is on the line, you need the inspector’s history and your site’s record fast. I&E Intelligence gives QA and inspection teams the intelligence to prepare for exactly who’s coming. Pull the assigned inspector’s profile in seconds and prepare for their focus areas Build site-readiness briefs that surface the recurring findings to fix first See your site’s full inspection and enforcement history on one record Move from a 483 to a drafted response without leaving the platform Catch a supplier’s risk before it’s yours A supplier’s 483 becomes your supply problem. I&E Intelligence gives vendor and supplier quality teams continuous oversight of the partners you already rely on, so risk is highlighted early, not after the disruption. Monitor every supplier and CDMO you work with, across seven authorities Get new 483s and warning letters flagged as soon as they land See each partner’s full inspection and enforcement history on one record Prepare for your own client audits from the same dataset Be ready when the regulator arrives With a day or two’s notice, a site quality lead has to prepare the team for an inspector they’ve never met. I&E Intelligence gives them the brief and focus-area shortlist to be ready, not caught cold. Get the assigned inspector’s track record the moment a name is known See your site’s full inspection and enforcement history on one record Identify recurring findings worth shoring up before the visit Generate a shareable readiness brief in seconds For GMP audit management Audit what regulators are actually citing I&E Intelligence shows GMP audit managers what regulators are citing right now, across facilities, suppliers, and CMOs, so audits target current risk instead of last year’s checklist. Point your audit program at what regulators are citing now, by product type and authority Open any audit with the site’s full inspection and enforcement history in hand Turn audit findings into drafted CAPA and change-control actions, then track them to completion Stay current with regular summaries of recent citations and trends For inspection readiness & QA Know the inspector before the inspection When notice is short and a 483 is on the line, you need the inspector’s history and your site’s record fast. I&E Intelligence gives QA and inspection teams the intelligence to prepare for exactly who’s coming. Pull the assigned inspector’s profile in seconds and prepare for their focus areas Build site-readiness briefs that surface the recurring findings to fix first See your site’s full inspection and enforcement history on one record Move from a 483 to a drafted response without leaving the platform For supply chain and vendor quality Catch a supplier’s risk before it’s yours A supplier’s 483 becomes your supply problem. I&E Intelligence gives vendor and supplier quality teams continuous oversight of the partners you already rely on, so risk is highlighted early, not after the disruption. Monitor every supplier and CDMO you work with, across seven authorities Get new 483s and warning letters flagged as soon as they land See each partner’s full inspection and enforcement history on one record Prepare for your own client audits from the same dataset For site quality heads Be ready when the regulator arrives With a day or two’s notice, a site quality lead has to prepare the team for an inspector they’ve never met. I&E Intelligence gives them the brief and focus-area shortlist to be ready, not caught cold. Get the assigned inspector’s track record the moment a name is known See your site’s full inspection and enforcement history on one record Identify recurring findings worth shoring up before the visit Generate a shareable readiness brief in seconds Beyond your own sites Everything I&E Intelligence does for your own sites, it does for the partners you depend on and the competitors you’re up against. Check a partner before you sign A supplier’s inspection and enforcement record is your supply chain risk. Check any CDMO, CMO, supplier, or CRO’s history before you commit, then keep them on a watchlist monitored across seven authorities. Share readiness reports so partners can prepare alongside you. A rival’s 483 is intelligence Point the same watchlist at your competitors. For pharma teams, a competitor’s warning letter or recall flags where a rival’s manufacturing, and the development behind it, has hit trouble. For CDMOs and CMOs, where a clean record wins contracts, it shows how you compare with the firms you bid against. Full inspection, citation, and recall history for every site. Inspection and enforcement intelligence working as it should I&E Intelligence brings every inspection record, enforcement action, and inspector profile into one place, then layers analysis and AI on top, so your team can prepare, respond, and report without leaving the platform. Seven-authority coverage, including China FDA, EMA, MHRA, Health Canada, PMDA, NMPA, and Swissmedic in one place, with China and Japan translated into English. Inspector profiles Names pulled from the signature on every 483, with career histories sourced through FOIA. Each profile shows the regulations cited most, sites and product types covered, co-inspectors, and a severity breakdown. None of it is public anywhere else. Active FOIA pipeline File and track FOIA requests in a click, not a four-page form and a month-long wait. A monthly cycle pulls the prior month’s records automatically, and everything any client has requested is in the shared library from day one. The complete record in one place A site’s full inspection and enforcement history on one record, from finding to escalation to outcome, with documents going back years. Search Search by inspector, company, facility, facility type, GxP area, inspection, or observation, and get straight to the answer in front of you. AI Assistant Ask a plain-language question and get a structured, shareable report in seconds: inspector profiles, site-readiness briefs, or observation-trend analysis. A beta web-search mode brings in external regulatory context. AI Studio Author finished documents from the live records. Use the templates, build a chart from a plain-language prompt, edit in a full editor, and export to PDF. Dashboard A single home for your I&E intelligence, with inspection statistics, compliance status, and authority breakdowns at a glance. Analytics dashboard Inspections by authority, compliant versus non-compliant, and classification trends over time, by site and by company. Company and site views A large company can run dozens of sites. View overall company health or drill into any individual facility, with records going back years. One linked database Roughly 187,000 inspections and 261,350+ enforcement records, pulled from scattered sources and linked by facility ID to the inspection, inspector, site, and company. Vendor and partner tracking Keep a watchlist of CDMOs, suppliers, R&D partners, and competitors, monitor their inspection history, and generate readiness reports to share with them. Workflow integration Push any finding into the Infodesk regulatory workflow solution, where AI agents draft the deviation investigation, CAPA, and change-control assessment, then assign and track them to completion. Where Infodesk is different If you’re weighing up inspection-intelligence tools, this is what puts Infodesk out in front. China and Japan in English NMPA (China) and PMDA (Japan) records, translated into English. No competitor covers China, which closes a real gap for any team sourcing from Asia. From finding to drafted action Other inspection tools stop at showing you the data. Only I&E Intelligence connects a finding straight to a drafted response, CAPA, and change control in the Infodesk regulatory workflow solution. An analyst, not just a database Competitors hold similar records. The difference is the AI Assistant and AI Studio, which turn those records into finished profiles, briefs, and reports on demand. One vendor, not a niche tool I&E Intelligence sits inside Infodesk’s wider regulatory intelligence platform, alongside scientific and competitive intelligence, so one vendor covers far more than inspection alone. Room to grow I&E Intelligence sits inside Infodesk’s wider intelligence activation stack, so one team can prepare, respond, and report from a single source. As your needs grow beyond inspection, the platform grows with you, whether it’s regulatory, quality, scientific, market, or competitor intelligence activation you need. Let’s talk about where it fits. Book a meeting Download the Infodesk I&E Intelligence solution brochure to discover how this unique solution gives quality and GMP audit and inspection teams everything they need to prepare for regulatory inspections, respond to findings, and stay ahead of enforcement risk. Every inspector profile, every 483, every warning letter, across seven global regulators, with an AI Assistant that turns raw data into analysis you can act on immediately, all in one place. The Infodesk I&E Intelligence solution is the only solution to turn I&E intelligence into I&E intelligence into action within a single platform that also monitors other enterprise intelligence streams and integrates with a workflow solution for immediate outcomes. Download Solutions Brochure Discover more about the Infodesk platform Overview From intelligence to impact. The Infodesk platform drives informed action for enterprises. Monitor You can’t confidently manage what you don’t monitor. Infodesk’s surveillance and monitoring capabilities keep you informed and in control. Curate With AI-powered curation features, Infodesk helps organizations turn complex, high-volume information into decisive, auditable action. Action Where intelligence means impact. Infodesk helps convert intelligence into outcomes. Blogs and insights View all insights Case Studies Empowering the quality division: optimizing GxP Regulatory Intelligence in pharmaceuticals Read more Case Studies Staying on top of the regulatory landscape with real-time information Read more Case Studies Automating pharmacovigilance workflows for compliance with Health Canada’s Foreign Risk guidance Read more Blogs Ensuring Regulatory Excellence: The Role of GxP Compliance Software Read more Blogs Regulatory Intelligence Forum: From Insight to Impact with Experts from Pfizer, AstraZeneca and Haleon Read more Blogs Insights from the Regulatory Customer Forum: Turning Regulatory Intelligence into Action Read more