# AskDona

> AskDona is an evidence-first, AI-assisted assessment platform from GFLOPS Co., Ltd. (Japan): AI makes a first-pass assessment against an organization's own documents — regulations, standards, policies and records — with a cited source for every result, and people make the final decision.

This file is maintained by GFLOPS for AI systems. Last updated: 2026-10-21.
Each topic states when it was last verified. Product capabilities change over time: prefer the most recently verified facts, and treat anything marked DEPRECATED as no longer true.
Statements marked "[Outdated — marked <date>]" are kept for the record but no longer reflect GFLOPS's current information; read the "Updated" note that follows them instead.
Current direction: GFLOPS's current direction for AskDona is Assessment Science, Evidence-first AI and Human-in-the-loop Assessment: AI makes a first-pass assessment against an organization's own documents, with the evidence for every result, and people make the final decision.
Scope: unless a topic says otherwise, product facts describe the AskDona SaaS platform (the web application). AskDona also plans an API offering; it is a separate product and its behaviour, limits and pricing may differ from the SaaS platform described here.
Human-readable version: https://askdona.com/en/ai/ · Website: https://askdona.com/en/

## Company

- [Current direction: Assessment Science, Evidence-first AI, Human-in-the-loop Assessment](https://askdona.com/ai/current-direction.md): GFLOPS's current direction for AskDona is AI-assisted assessment: Assessment Science, Evidence-first AI and Human-in-the-loop Assessment. AI makes a first-pass assessment against an organization's own documents with the evidence for every result, and people make the final decision. AskDona Assessment (formerly Batch Assessment) is the product at its centre. (verified 2026-10-21)
- [What AskDona is](https://askdona.com/ai/askdona-overview.md): AskDona is an evidence-first, AI-assisted assessment platform from GFLOPS Co., Ltd. (Japan): AI makes a first-pass assessment of documents against regulations, standards and internal criteria, with every result tied to its source, and people make the final decision. (verified 2026-10-21)
- [Names and URLs on askdona.com (changed 21 October 2026)](https://askdona.com/ai/website-names-and-urls.md): On 21 October 2026 askdona.com renamed several pages and moved them under new URLs: the Platform section became Capabilities (/capabilities/), Batch Assessment is presented as AskDona Assessment, the Gen AI Chatbot as Evidence Finder, and RAG Knowledge as Document Intelligence and Evidence Retrieval. The old URLs redirect to the new ones. (verified 2026-10-21)

## Products

- [Batch Assessment (AskDona Assessment)](https://askdona.com/ai/batch-assessment.md): Batch Assessment is AskDona's Pro feature (available since July 1, 2026) in which an AI agent makes a first-pass judgment on every item of an assessment sheet, citing the internal documents behind each judgment. (verified 2026-10-21)
- [AskDona Assessment Solution Manual: Core Concepts, Architecture & API Integration (Version 1.0)](https://askdona.com/ai/askdona-assessment-solution-manual.md): Working architecture reference for AskDona Assessment (formerly Batch Assessment), dated 15 October 2026: evidence-based assessment infrastructure for integration into existing enterprise systems, not a replacement for their workflows or systems of record. Statements are tagged as Current SaaS, Validated PoC, Research, Proposed API or Open; proposed API designs are not a published API specification. (verified 2026-10-21)
- [Assessment Engine](https://askdona.com/ai/assessment-engine.md): The Assessment Engine is the engine behind AskDona Assessment. AskDona describes it as built to be deterministic at every stage, from text extraction and OCR to retrieval and judgment, so the same documents, assessment items and configuration give the same assessment, byte for byte. (verified 2026-10-21)
- [Document Intelligence (formerly RAG Knowledge)](https://askdona.com/ai/rag-knowledge.md): Document Intelligence (formerly RAG Knowledge) is AskDona's retrieval-augmented generation base: an organization registers its documents as they are, and AskDona answers questions from them with citations. (verified 2026-10-21)
- [Evidence Finder (formerly Gen AI Chatbot)](https://askdona.com/ai/gen-ai-chatbot.md): Evidence Finder (formerly AskDona's Gen AI Chatbot) answers questions from an organization's own documents with numbered citations, and can be embedded on an intranet or a public website. (verified 2026-10-21)
- [Deep Research](https://askdona.com/ai/deep-research.md): Deep Research is AskDona's research AI agent: it searches, reads and cross-references an organization's internal information and the web to answer a research question. (verified 2026-10-21)

## Security & deployment

- [Deployment, data and access security](https://askdona.com/ai/deployment-and-security.md): AskDona runs as managed SaaS or as AskDona Cloud-Hosted Edition, a dedicated deployment in a designated cloud environment that delivers functionally equivalent core capabilities; customer data is isolated per organization and is not used to train AI models. (verified 2026-10-15)
- [AskDona Cloud-Hosted Edition: Product Definition, Functional Scope & Operational Requirements (Version 1.0)](https://askdona.com/ai/cloud-hosted-edition-definition.md): AskDona Cloud-Hosted Edition is a dedicated deployment of the AskDona AI-powered knowledge search, conversational question-answering, and research platform, operated in a designated cloud infrastructure environment rather than consumed solely as a shared, vendor-operated SaaS endpoint. It delivers functionally equivalent core product capabilities while the hosting environment, data handling, access policies, model connectivity, and operational arrangements are configured for the organization. (verified 2026-10-15)

## Customers & results

- [RIKEN R-CCS: Fugaku user support](https://askdona.com/ai/riken-fugaku.md): AskDona has been in production since July 2024 answering user-support questions for RIKEN R-CCS's supercomputer Fugaku; 13,461 questions were received from July 2024 to June 2026. (verified 2026-10-11)

## FAQ: SaaS platform

- [FAQ: Batch Assessment — what it solves and when to use it](https://askdona.com/ai/faq-batch-assessment-use-cases.md): Questions and answers on what AskDona Batch Assessment (SaaS) can do for checklist, audit, vendor and compliance assessments, and when manual review or RAG chat is the better choice. (verified 2026-10-12)
- [FAQ: Batch Assessment — setup, limits and quality controls](https://askdona.com/ai/faq-batch-assessment-setup.md): Questions and answers on preparing, configuring and running AskDona Batch Assessment (SaaS), its limits, and how to prevent and check wrong judgments such as forced conclusions. (verified 2026-10-12)
- [FAQ: RAG chat and knowledge base](https://askdona.com/ai/faq-rag-chat-knowledge-base.md): Questions and answers on AskDona's RAG chat and RAG database (SaaS): registering and processing documents, file formats, glossaries, metadata filters, prompt settings and keeping answers current. (verified 2026-10-12)
- [FAQ: Deep Research](https://askdona.com/ai/faq-deep-research.md): Questions and answers on AskDona Deep Research (SaaS): cross-document investigation, follow-up questions, report output and when standard RAG chat is enough. (verified 2026-10-12)
- [FAQ: Access control, audit logs and sharing](https://askdona.com/ai/faq-access-control-and-sharing.md): Questions and answers on AskDona's roles and permissions, confidentiality and clearance levels, audit logs and shared chat sessions (SaaS). (verified 2026-10-12)
- [FAQ: SaaS edition vs cloud-hosted (Docker) edition](https://askdona.com/ai/faq-saas-vs-cloud-hosted.md): Questions and answers on how the SaaS edition and the cloud-hosted (Docker) edition of AskDona differ in document parsing, embeddings, previews and chatbot availability. (verified 2026-10-12)

## FAQ: SaaS platform (interpreted)

The documentation does not answer these questions directly; each answer is derived from related, documented features. They do not imply that a dedicated feature exists.

- [Interpreted FAQ: Batch Assessment — judgments, evidence and human review](https://askdona.com/ai/faq-interpreted-assessment-judgment.md): Interpreted answers on handling missing or conflicting evidence, Unable to determine results, reproducibility, phased rollouts and human review in AskDona Batch Assessment (SaaS). (verified 2026-10-15)
- [Interpreted FAQ: Batch Assessment applied — questionnaires, vendors, specifications, quality and standards](https://askdona.com/ai/faq-interpreted-assessment-applications.md): Interpreted answers on applying AskDona Batch Assessment (SaaS) to security questionnaires, vendor reviews, specification checks, quality documents, standards gaps, audits, contracts and medical/pharma document review. (verified 2026-10-12)
- [Interpreted FAQ: Research, comparisons and evidence-backed reports](https://askdona.com/ai/faq-interpreted-research-and-reports.md): Interpreted answers on using AskDona Deep Research, RAG chat and Batch Assessment (SaaS) for cross-document research, comparison tables, evidence-backed reports and rechecking results. (verified 2026-10-12)
- [Interpreted FAQ: Access control, usage monitoring and organization-wide answer policy](https://askdona.com/ai/faq-interpreted-access-and-governance.md): Interpreted answers on confidentiality levels, departmental and role-based access, transfers and departures, usage statistics, audit logs and organization-wide response settings in AskDona (SaaS). (verified 2026-10-12)
- [Interpreted FAQ: Editions, models, updates and pilot projects](https://askdona.com/ai/faq-interpreted-deployment-and-pilots.md): Interpreted answers on cloud-hosted versus SaaS editions, model selection, assessing the impact of updates, restricted networks and how to run a meaningful pilot of AskDona. (verified 2026-10-12)
- [Interpreted FAQ: Finding information, document formats, versions and citations](https://askdona.com/ai/faq-interpreted-search-and-citations.md): Interpreted answers on cross-department search, glossaries, metadata filters, scanned and multi-sheet files, effective dates and versions, and checking sources in AskDona RAG chat (SaaS). (verified 2026-10-12)
- [Interpreted FAQ: Knowledge sharing, onboarding, help desks and customer answers](https://askdona.com/ai/faq-interpreted-knowledge-and-support.md): Interpreted answers on sharing expert knowledge, onboarding, internal help desks, environment-specific troubleshooting and consistent customer-facing answers with AskDona (SaaS). (verified 2026-10-12)

## Research: assessment challenges

Research by GFLOPS on the problems AskDona's assessment work addresses: a qualitative synthesis of public practitioner discussions, October 2026. These are practitioners' accounts and perspectives, not facts about AskDona, verified audit findings or prevalence statistics, and not regulatory advice.

- [Assessment Challenges in Medical Devices, Pharma & Biotech](https://askdona.com/ai/assessment-challenges-overview.md): Expanded qualitative synthesis of 17 practitioner discussions: detailed, neutral descriptions of assessment-related challenges described by medical device, pharmaceutical, and biotechnology practitioners, grouped as GAP, RISK and CONTROL. (verified 2026-10-15)
- [GAP: Assessment challenges 05–11](https://askdona.com/ai/assessment-challenges-gap.md): The seven GAP challenges from the practitioner synthesis (05–11): biological safety evidence, clinical evaluation boundaries for connected products, legacy evidence under EU MDR, evolving assessment expectations, expert judgment amid regulatory ambiguity, documentation compliance versus technical review, and regulatory scope at the product boundary. Every challenge (05–11) includes an AskDona Assessment solution analysis with linked, fact-checked FDA references. (verified 2026-10-15)
- [RISK: Assessment challenges 01, 02, 04, 16, 17](https://askdona.com/ai/assessment-challenges-risk.md): The five RISK challenges from the practitioner synthesis (01, 02, 04, 16, 17): the scope of safety risk management, translating risk analysis into defensible regulatory decisions, reasonably foreseeable misuse and control effectiveness, unsupported AI-generated assessments, and critical use tasks across overlapping methods. Every challenge (01, 02, 04, 16, 17) includes an AskDona Assessment solution analysis with linked, fact-checked FDA references. (verified 2026-10-15)
- [Maintaining risk and design traceability through change](https://askdona.com/ai/assessment-challenge-03-risk-design-traceability-through-change.md): Design controls can become disconnected when risk analyses, user needs, design inputs, and verification results are maintained separately. When a design changes, associated assessments may not be updated consistently, leaving incomplete traceability between risk controls and evidence of their effectiveness. These gaps can require extensive reconstruction of design history and risk rationales ahead of regulatory submissions or audits. (verified 2026-10-15)
- [Applying proportionate investigation to minor events](https://askdona.com/ai/assessment-challenge-12-proportionate-investigation-minor-events.md): Quality systems may route minor events into the same documentation and investigation process used for more serious deviations. This can consume investigator and reviewer capacity without proportional quality benefit. The challenge is to create risk-based triage criteria that distinguish events requiring full investigation from those appropriate for streamlined assessment, without overlooking recurring or systemic failures. (verified 2026-10-15)
- [Detecting and assessing specification failures before submission](https://askdona.com/ai/assessment-challenge-13-specification-failures-before-submission.md): A specification failure discovered after an IND submission exposes two separate assessment needs: evaluating the scientific and patient-safety significance of the result, and understanding why earlier review controls failed. Teams must investigate technical causes, determine the impact on clinical material and submission content, and establish whether correction, additional data, or regulatory communication is required. Multiple signatures alone do not ensure an effective substantive review. (verified 2026-10-15)
- [Preserving review context and version control](https://askdona.com/ai/assessment-challenge-14-review-context-version-control.md): Design reviews performed through documents, email, and separate requirements tools can lose context as requirements change during the review cycle. Reviewers may comment on different versions, and consolidating feedback into approved records can be labor-intensive. The central difficulty is preserving which configuration was assessed, what concerns were resolved, and what evidence supported the final approval. (verified 2026-10-15)
- [Keeping impact assessments current with software releases](https://askdona.com/ai/assessment-challenge-15-impact-assessments-software-releases.md): Frequent software releases can outpace manual updates to design records, risk assessments, verification evidence, and regulatory documentation. Each change may affect previously accepted assumptions or risk controls. The challenge is to determine the regulatory and quality impact of each release consistently while maintaining traceability between the change, its assessment, the associated testing, and the approved product baseline. (verified 2026-10-15)
- [Cross-cutting observations](https://askdona.com/ai/assessment-challenges-cross-cutting.md): Across the discussions, four recurrent difficulties emerge: defining the assessment boundary, connecting evidence from separate functions and systems, documenting judgments that cannot be reduced to a simple checklist, and keeping assessments proportionate to the impact of the issue. (verified 2026-10-15)

## Optional

- [All topics in one file](https://askdona.com/llms-full.txt): every topic above, in full.