FAQ

Questions people ask before putting real biotech work into XYNX.

From file handling and scientific review to AI governance and regulated workflows, find direct answers to how XYNX works.

Search FAQs

Getting Started

Do I need to create a complete drug program before I start?

No. Start with the materials or Study in front of you. You can organize the wider program as the work develops.

Is every Data Room tied to a CRO?

No. A Data Room can hold internal research, literature, consultant work and partner deliverables. A CRO relationship is not required.

Files & Data Rooms

What file types can I upload?

The document workflow is designed around PDF, Word, Excel, CSV and scientific figures. Upload, preview, text extraction and structured analysis are different capabilities; confirm supported formats, size limits and parsing coverage for your intended use before uploading. This prototype uses synthetic files.

What happens when a new version is uploaded?

A new version is kept alongside the previous version. Earlier evidence, comments and decisions retain their original version context. A revision needs review; uploading it does not automatically resolve an issue.

Does AI modify my source file?

No. AI suggestions and working copies are separate from the source. People review proposed changes and explicitly accept or reject them; AI does not silently overwrite the original.

AI Review

Can XYNX find scientific issues, or only consistency issues?

AI can help flag potential scientific concerns as well as inconsistencies, missing information and evidence gaps. Coverage depends on the materials, method and scope. A flag is a candidate for qualified human review, not proof of an error or a complete scientific assessment.

Can AI make the final scientific or regulatory decision?

No. AI can flag, compare, explain and draft. Qualified people remain responsible for scientific judgments, regulatory decisions and approval. An AI output is not a signed professional opinion.

Can I see the evidence behind an AI finding?

Findings are designed to link to the source, exact version and passage. Review that evidence in context. An unsupported suggestion must not be treated as an established finding.

AI & Data Governance

Is customer data used to train AI models?

Customer documents are not used to train a shared foundation model. Provider, endpoint, retention and contractual terms must be confirmed for the configured AI processing; a no-training commitment does not by itself mean zero retention.

If customer documents are not used for training, how does XYNX improve its AI?

Improvement can come from better workflows, prompts, retrieval, review methods and evaluations using public, licensed or synthetic materials. Customer documents are not required for shared-model training. Any separate use of customer material requires an explicit lawful agreement.

What is Zero Data Retention?

Zero Data Retention (ZDR) is a provider-specific arrangement limiting retention of eligible AI request content. It applies only where supported and configured, subject to the provider’s terms and exceptions. It does not mean files stored in your Data Room are deleted, or that no operational metadata exists.

Security & Compliance

Where is XYNX customer data stored?

The planned default is AWS infrastructure in the United States. Confirm the agreed storage region, subprocessors and AI processing locations before using XYNX for confidential materials. Storage location and AI processing location are separate questions.

Is data encrypted?

The security design calls for encryption in transit and at rest. Confirm the implemented controls and contractual scope for your environment before relying on them for confidential or regulated records.

Is XYNX SOC 2 certified?

XYNX does not claim a completed SOC 2 examination. SOC 2 is an attestation report, not a certification. SOC 2 Trust Services Criteria inform the controls and evidence program; XYNX is building toward independent SOC 2 Type II attestation.

Is XYNX ISO/IEC 27001 certified?

XYNX does not claim ISO/IEC 27001 certification. Security practices are being developed with ISO/IEC 27001 information-security principles in mind. Certification should only be relied on when its certificate and scope are available.

Is XYNX 21 CFR Part 11 compliant?

There is no blanket Part 11 certification for every use of XYNX. Required controls and validation depend on intended use, configuration and the customer’s regulated process. Assistive review or drafting is different from an authoritative system of record for regulated electronic records or signatures.

Can XYNX support GxP workflows?

XYNX is designed with traceability, version history, user attribution, source integrity and human review in mind. GxP use requires a defined intended use, appropriate validation, configuration and customer quality procedures. A public website or prototype is not validation evidence.

Collaboration

What happens if two people review the same report?

Reviews stay tied to the same exact report version, with author attribution and discussion history. A colleague’s comment does not silently replace another person’s judgment. Live simultaneous editing depends on the configured application; this prototype does not guarantee cross-tab real-time synchronization.

Can a CRO see internal comments?

A CRO should see only the materials and comments explicitly shared within its authorized scope. Internal discussions are not automatically shared. Check the sharing preview and recipients before granting access.

Does a CRO response automatically close an issue?

No. A response or revised file is new evidence to review. An authorized person checks the response and supporting version before explicitly updating the issue status.

Life Science Services

Does XYNX only provide software?

No. XYNX combines an AI Data Room with scoped life-science review, writing and consulting engagements. Services are commissioned separately, with expertise, deliverables and availability confirmed for each engagement.

Are review and writing services fully human?

They are human-led and may use AI and software for evidence navigation, comparison and drafting. Appointed professionals review the work and remain responsible for the agreed professional deliverable. AI output alone is not a professional sign-off.

Can XYNX support scientific or regulatory writing?

Writing may be included in a separately scoped engagement, subject to suitable expertise and confirmed availability. Source evidence, authorship, review and approval responsibilities must be agreed. This does not imply regulatory submission authority or guaranteed acceptance.

Working with XYNX

How can consultants and specialist teams work with XYNX?

Independent consultants, subject-matter experts and specialist teams can discuss expert delivery, bringing their own clients, referrals or joint engagements. Referral fees, project compensation or revenue sharing may apply; terms depend on scope, model and partner role.