--- title: "Compliance Frameworks | Qualio" canonical: "https://www.qualio.com/compliance-platform/frameworks" updatedDate: "2026-11-03T14:11:02.000Z" description: "Automate and prove compliance. 30+ life sciences standards codified clause by clause, evidence cross-mapped across them, and AI gap analysis in under an hour." --- # Compliance Frameworks | Qualio Automate and prove compliance. 30+ life sciences standards codified clause by clause, evidence cross-mapped across them, and AI gap analysis in under an hour. ## Map once, comply everywhere The standards life sciences companies are held to, mapped clause by clause. One evidence base across all of them. AI gap analysis that reruns whenever a record changes. ## Regulatory complexity multiplies as you grow Your quality system passed its last audit. Then you sell into Canada and MDSAP becomes mandatory, a sponsor audit asks for ICH E6 R3, or your next product has software in it and IEC 62304 arrives with it. Most of what the new standard asks for, you are already doing. But the only way to find out which controls already answer it is a clause-by-clause review by hand. ### One standard becomes several QMSR, ISO 13485, EU MDR, MDSAP, ICH, each with its own clause list and spreadsheet ### Finding the gaps is a manual review Someone reads every clause against every record, or you pay a consultant to. ### The same evidence, standard by standard Effort spent twice, and the gaps in the overlap are the ones an auditor finds first. ## Add a standard without starting over Qualio breaks every standard down clause by clause and automatically assesses your records against each one. One control can satisfy several standards at once, so when you add a standard you see what your existing controls already cover, what is new, and where the gaps overlap. And it reads the records where they live: in Qualio, in your document store, or in a QMS you already run. Less audit prep time. A week became a day. Compliance coverage. ISO 13485 in 6 months, with no added quality headcount. ## Find it. Fix it. Prove it closed. ### 1. Scope it Choose the standard from the catalog, or build your own. Then point it at your policies and records: connect your QMS or document store, or upload the files yourself. ### 2. Qualio assesses, clause by clause AI reads each record against each clause of the standard and returns findings. Every finding cites the clause it applied and the record it read. ### 3. Close the gap, not just log it Every finding carries a recommendation, and Copilot drafts the fix from it: the procedure update, the change control, the CAPA, the tasks for the people who own them. Your team reviews and approves. ### 4. Something changes. It runs again A fix lands, a procedure is revised, a supplier is qualified. Qualio reassesses, confirms what closed, and flags what drifted. ## The standards you're audited against, already mapped In the library: - ISO 13485 - EU MDR - MDSAP - IEC 62304 - ISO 14971 - ICH Q7 to Q11 - [See the full catalog](/compliance-platform/frameworks/catalog) Plus a custom framework builder for the internal standards only your team carries. ## The assessment never stops running. A gap assessment is a snapshot. Revise one procedure or change one supplier and it is stale, and nobody finds out until the next audit. Qualio reruns the assessment whenever a record changes and flags any gap it opens. An audit running around the clock, with your team seeing the findings before an auditor does. And when the real one lands, you export the pack: every policy and piece of evidence, organised clause by clause the way the auditor reads it. - Reassessment triggered by a record change, not by a calendar date - Fixes verified on the next run, so a closed gap stays closed - Cross-framework view of where standards overlap and diverge, reported from live data - Audit pack export: every clause, with the policies, evidence and approvals behind it - Plan the next internal audit from the clauses with open gaps. See [audits](/compliance-platform/audits). ## Hear from our customers ## See it for your industry ### Medical Devices - ISO 13485 - EU MDR - MDSAP - IEC 62304 Templates pre-mapped to every clause; ISO 13485 to QMSR cross-reference; continuous monitoring with executive dashboards. [See medical devices](/frameworks/iso-13485) ### Pharma & Biotech - ICH E6 R3 - ICH Q7 to Q11 - GxP - GMP Clinical and manufacturing SOPs mapped to ICH and GxP, with Annex 11 monitoring. [See pharma and biotech](/frameworks/ich-e6-r3) ### GxP Software & AI - ISO 42001 - IEC 62304 - FDA 21 CFR Part 11 GAMP 5 category-mapped SOPs and CSV templates, Part 11 record verification, and AI system documentation aligned to ISO 42001. [See GxP software and AI](/solutions/software-and-ai) ## Explore Qualio’s framework library Tell us the standard you are most worried about. We will show you how Qualio addresses it, usually in the first conversation.