つくり手から学ぶ。 Learn from inside the build.
AskDonaのチームメンバーが、いまつくっているもの・開発しているものについて語る社内セッションのアーカイブ。機能やプロダクトの中身を、つくり手の視点からわかりやすく解説します。 An archive of internal show & tell sessions from the AskDona team — each one a teammate walking through what they're working on or shipping right now, so you get a closer look at how features and products actually come together.
01 · ウィジェット 01 · Widget NEW! NEW!
AskDona 生成AIチャットボット AskDona's Gen AI Chatbot
1行の <script> タグで任意のサイトに導入。出典付き回答・多言語対応・3段階のレスポンス深度を、ブランドカラーで。 Drop the AskDona chat widget on any site in one <script> tag — sourced answers, multilingual, three response depths, in your brand color.
- Embedスクリプトの貼り付けとchatflowIdの設定 Drop in the embed script and set your chatflowId
- ブランド色 / 表示モード (floating / fullscreen) の指定 Configure brand color and display mode (floating / fullscreen)
- JP/EN UIと自動言語検出 / 出典の取り扱い JP/EN UI with auto language detection · citations
02 · ガイドツアー 02 · Guided Tour NEW! NEW!
AskDona ガイドツアー Tour of AskDona
AskDona の主要な機能と使い方を、インタラクティブなツアーで一気に体験。チャット、検索、フォルダ、一括処理までを画面で追いながら把握できます。 Experience AskDona's key features and how to use them in one interactive tour — follow chat, search, folders and bulk processing right on screen.
- チャットと出典付き回答の基本操作 Chat basics and sourced answers
- 検索・フォルダ・ナレッジの扱い方 Working with search, folders and knowledge
- 一括処理までの流れを画面で確認 Follow the flow through to bulk processing
Guides and checklists for regulated assessment
Guides11
- 01 Medical devices QMSR Compliance Software: What Medical Device Makers Need After the FDA's 2026 Transition FDA's QMSR took effect Feb 2, 2026. Learn what changed, what inspectors now review, and the capabilities your QMSR compliance software needs.
- 02 Medical devices Design History File Software: How to Build an Inspection-Ready DHF Under QMSR QMSR dropped the term "DHF" but not the evidence. See what FDA inspectors check in design files in 2026 and what your DHF software must do.
- 03 Third-party risk AI Vendor Risk Assessment: How to Review Third-Party Evidence at Scale in 2026 Third-party breaches reached 48% in Verizon's 2026 DBIR. Learn how AI vendor risk assessment reviews SOC 2 and ISO evidence, not just questionnaires.
- 04 Medical devices CAPA Management Software for Medical Devices: What Changed Under QMSR CAPA was FDA's top device 483 citation in FY2025. See how QMSR changed CAPA, what inspectors check in 2026, and what your CAPA software needs.
- 05 Compliance AI Document Compliance Checker: How to Choose One You Can Defend to an Auditor GenAI use in professional firms nearly doubled to 40%. Learn how to pick an AI document compliance checker with cited evidence an auditor can verify.
- 06 Pharma AI Batch Record Review: Faster Release Without Weaker Data Integrity 21 CFR 211.192 is still a top FDA citation. Learn how AI batch record review and review by exception speed release while meeting GMP expectations.
- 07 Third-party risk Security Questionnaire Automation: How AI Answers Faster Without Overpromising Vendors face dozens of security questionnaires a month. Learn how AI questionnaire automation works, where it goes wrong, and how to keep answers accurate.
- 24 Pharma GMP Change Control Impact Assessment: A Practical Guide for Pharma Assess GMP changes for quality, validation and regulatory impact. Covers 21 CFR 211.100, 314.70 reporting categories, ICH Q10 and Q12, with a template.
- 25 Medical devices Medical Device Change Impact Assessment: When Do You Need a New 510(k)? Not evaluating changes is a possible OAI finding under QMSR. Learn how to assess device changes, decide on a new 510(k) and use PCCPs in 2026.
- 29 AI assessment Preventing Hallucinations in AI Compliance Assessments: Groundedness and RAG Evaluation Metrics Even RAG tools hallucinated in 17–34% of legal queries. Learn the groundedness and RAG metrics that keep AI compliance assessments trustworthy.
- 30 AI assessment Human-in-the-Loop Compliance AI: How Reliable Is LLM-as-a-Judge? LLM judges agree with humans about 80% of the time, but with known biases. Learn how to design human oversight for compliance AI in 2026.
Checklists & templates20
- 08 Third-party risk How to Review a Vendor SOC 2 Report: A 10-Point Checklist for 2026 Over half of SOC reports in one benchmark had exceptions. Use this 10-point checklist to review vendor SOC 2 reports: opinion, scope, CUECs, carve-outs and more.
- 09 Medical devices FDA QMSR Checklist: An ISO 13485 Gap Analysis for U.S. Device Makers An ISO 13485 certificate won't exempt you from FDA inspection. Use this QMSR checklist to find the U.S.-specific gaps FDA inspects in 2026.
- 10 Medical devices EU MDR Technical Documentation Checklist: Annex II, Annex III and the GSPR Matrix Only 14 of 52 MDR notified bodies say most submissions are complete. Use this Annex II, Annex III and GSPR matrix checklist before you submit.
- 11 Medical devices ISO 14971 Risk Management Checklist: What FDA Inspectors Look for in 2026 Risk management is FDA's top QMSR inspection finding. Use this clause-by-clause ISO 14971 checklist to close the gaps inspectors cite.
- 12 Medical devices Design Verification vs Design Validation: Medical Device Checklists for 2026 Verification proves outputs meet inputs; validation proves the device meets user needs. See QMSR-era checklists and what changed in 2026.
- 13 Compliance FDA 483 Response Checklist: How to Answer Observations in 15 Business Days Respond to an FDA 483 within 15 business days and FDA reviews it before deciding on a warning letter. Use this 2026 checklist and avoid common mistakes.
- 14 Pharma GMP Data Integrity Checklist: ALCOA+, Audit Trails and 2026 Expectations 15% of 2025 FDA drug warning letters cited data integrity. Use this GMP data integrity checklist based on FDA, MHRA and the 2025 EU Annex 11 draft.
- 15 Compliance 21 CFR Part 11 Audit Checklist: Electronic Records and Signatures in 2026 A clause-by-clause 21 CFR Part 11 audit checklist covering controls, audit trails and e-signatures, plus FDA's enforcement discretion and 2026 updates.
- 16 Third-party risk Vendor Risk Assessment Checklist: A Third-Party Risk Template with Scoring Only 36% of third parties get assessed. Use this vendor risk assessment checklist, built on the interagency guidance and NIST CSF 2.0, with a scoring model.
- 17 Information security ISO 27001 Gap Analysis: Checklist and Software Guide for 2026 ISO 27001:2013 certificates expired Oct 31, 2025. Run an ISO 27001:2022 gap analysis with this clause and Annex A checklist and pick the right software.
- 18 Information security NIST CSF 2.0 Gap Assessment Template: Current vs Target Profiles Run a NIST CSF 2.0 gap assessment with Current and Target Profiles across all six functions, including Govern. Template, steps and 2026 updates.
- 19 Medical devices Medical Device Complaint Handling: FDA Requirements, MDR Reportability and a 2026 Checklist Complaint handling is a top-3 FDA finding under QMSR. Learn the § 820.35 record rules, MDR 30-day and 5-day timelines, and use this 2026 checklist.
- 20 Medical devices Medical Device Supplier Qualification and Audit Checklist Under QMSR Outsourcing and purchasing is FDA's #2 QMSR finding. Use this supplier qualification, audit and quality agreement checklist built for 2026 inspections.
- 21 Compliance CAPA Effectiveness Check Template for Medical Device and GMP Teams CAPA was FDA's top device 483 citation in FY2025. Use this CAPA effectiveness check template to set criteria, measure results and close with evidence.
- 22 Pharma GMP Deviation Investigation Checklist and Template for Pharma QA 21 CFR 211.192 was FDA's #2 drug citation in FY2025. Use this deviation investigation checklist and template to find real root causes, not "human error."
- 23 Pharma Batch Release Checklist: Documentation Requirements in the US and EU What QA must confirm before releasing a batch under 21 CFR 211 and EU Annex 16. A practical batch release checklist plus 2026 trends in faster release.
- 26 Pharma ICH Q9(R1) Quality Risk Management Template: What Changed and How to Apply It ICH Q9(R1) tackles subjectivity, formality and drug shortages. Use this quality risk management template to apply the revision in 2026.
- 27 Medical devices Medical Device Post-Market Surveillance Checklist: FDA and EU MDR in 2026 One PMS checklist for FDA (Parts 803, 806, 822, 821) and EU MDR (Articles 83–86), with 2026 changes: AEMS, MDCG 2025-10 and the PSUR reform proposal.
- 28 Medical devices Design Traceability Matrix Template for Medical Devices (QMSR and Software) Build a design traceability matrix that links user needs, inputs, outputs, V&V and risk controls, aligned with QMSR and FDA's 2023 software guidance.
- 31 Medical devices ISO 13485 Internal Audit Checklist: QMSR-Ready for 2026 FDA can now read your internal audit reports. Use this QMSR-ready ISO 13485 internal audit checklist, aligned with FDA's six inspection areas and ISO 19011:2026.