Question 1

What is docxpert.io?

Accepted Answer

docxpert.io is an AI-powered QMS software for ISO-certified companies. We offer intelligent document control, automatic compliance checks, gap analyses and more for ISO 9001, ISO 13485, IATF 16949 and other standards.

Question 2

Who is docxpert.io suitable for?

Accepted Answer

For companies with ISO 9001, ISO 13485, IATF 16949 or other QM standards. Particularly suitable for Medtech, Pharma, Automotive and manufacturing companies with 10-500 employees.

Question 3

Which standards are supported?

Accepted Answer

The platform supports workflows for ISO 9001, ISO 13485, IATF 16949, ISO 14001, ISO 27001 and ISO 45001. AI-assisted gap analysis suggests mappings; it is not proof that a model was trained on a particular standard or that requirements are met.

Question 4

Is docxpert.io cloud-based?

Accepted Answer

Yes, docxpert.io is a cloud SaaS solution. Data locations and external AI processing vary by service; please consult the privacy policy and request current contractual details before relying on a residency claim.

Question 5

Can I try docxpert.io?

Accepted Answer

Yes, we offer a 14-day free trial with 300 credits. No credit card required.

Question 6

How does AI document generation work?

Accepted Answer

The AI analyzes your requirements and generates structured documents based on templates and your document base. You can create documents via wizard or conversational chat.

Question 7

Are AI outputs validated for GxP or ISO 13485?

Accepted Answer

No universal regulatory validation is claimed. Model and prompt versions provide traceability for supported workflows, not deterministic results or approved use in every regulated process. Human review exists in specific document and approval workflows; it is not an automatic gate for every AI response. Your organization must validate intended use and review consequential outputs.

Question 8

How is a gap or coverage percentage assessed?

Accepted Answer

Coverage depends on the selected requirement set, included documents, mapping method and evidence at the time of assessment. Missing evidence and AI-suggested matches must not be confused with confirmed compliance; a qualified person should check exclusions, evidence and findings. Demo percentages are illustrative, not certification.

Question 9

What is the difference between Review and Approval?

Accepted Answer

Review is the technical review by an expert. Approval is the final release by an authorized person (e.g., QM Manager). Both steps are included in the two-step workflow.

Question 10

How secure is the blockchain integration?

Accepted Answer

Optional Integritas/Minima.global stamping can provide an additional integrity proof for selected events when configured and successfully processed. Not every event is stamped; it does not establish regulatory compliance or guarantee auditor acceptance.

Question 11

Can I manage CAPA processes?

Accepted Answer

Yes, complete CAPA management with Root Cause Analysis (5-Why, Ishikawa), action plan, effectiveness validation and KPI tracking. ISO 13485, ISO 9001 and IATF 16949 compliant.

Question 12

How does the Regulatory Radar work?

Accepted Answer

Automatic scanners monitor regulatory changes daily (EU MDR, FDA, SAHPRA, etc.). For relevant changes, you receive an email with AI impact analysis.

Question 13

What are controlled copies?

Accepted Answer

Printed documents with unique QR code for verification. You can revoke copies, set expiry dates and track all issuances in the audit trail.

Question 14

How accurate is the gap analysis?

Accepted Answer

The AI achieves an accuracy of approximately 85-90% when mapping documents to ISO requirements. We recommend manual review of critical requirements.

Question 15

Can I manage processes?

Accepted Answer

Yes, complete process management with process map, ISO chapter mapping, process owner assignment and document linking.

Question 16

Which plan is right for me?

Accepted Answer

The current pricing page offers Pay-As-You-Go access (€89/month baseline plus €125 per 1,000-credit package) and monthly credit packages without a baseline fee: 5,000 credits for €325, 10,000 for €600, 25,000 for €1,375, 35,000 for €1,750, or 50,000 for €2,250.

Question 17

Can I upgrade anytime?

Accepted Answer

The public pricing page shows Pay-As-You-Go access and monthly credit packages. It does not specify billing-change timing or proration terms; check with us before changing an existing arrangement.

Question 18

Is there a free trial?

Accepted Answer

Yes. The trial lasts 14 days and includes 300 credits. No credit card is required. The pricing page separately identifies some premium features as available after an upgrade.

Question 19

What are credits?

Accepted Answer

Credits are used with AI features. The current pricing page offers 1,000-credit packages for €125 as needed, or monthly credit packages from 5,000 to 50,000 credits. The amount of credit use depends on the feature.

Question 20

Are there volume discounts?

Accepted Answer

The current public pricing page lists fixed monthly prices for the credit packages shown. It does not state additional volume discounts.

Question 21

Which payment methods are accepted?

Accepted Answer

Accepted payment methods are not specified on the public pricing page. Please ask us about payment options before purchasing.

Question 22

Where is data stored?

Accepted Answer

A blanket EU-only or no-third-country-transfer commitment is not verified here. See the privacy policy for the services involved and request current provider and transfer details.

Question 23

Is the software GDPR compliant?

Accepted Answer

We provide privacy controls and information in our privacy policy. No blanket certification or legal-compliance guarantee is implied; request current contractual and audit evidence for your assessment.

Question 24

Is there an API?

Accepted Answer

Yes. An active monthly commitment package includes customer REST API access with no extra API access fee. Actions priced in credits use credits as usual. The API currently supports document metadata, downloads, drafts and review requests; human approvals and signatures remain in the application.

Question 25

Which browsers are supported?

Accepted Answer

Chrome, Firefox, Safari, Edge (current versions and one version back). The app is responsive and works on desktop, tablet and smartphone.

Question 26

Is there a mobile app?

Accepted Answer

The web app is fully responsive and works on all devices. A native mobile app is planned for 2026.

Question 27

How does backup work?

Accepted Answer

Automatic daily backups with 30-day retention. Point-in-time recovery possible. Backups are encrypted and stored in separate data center.

Question 28

What security measures are in place?

Accepted Answer

SSL/TLS encryption, multi-tenant isolation, role-based access control, 2FA, regular penetration tests, SOC 2 Type II certification in preparation.

Question 29

How long does implementation take?

Accepted Answer

Basic setup in 1 day (tenant creation, user setup). Complete onboarding with document import and training 1-2 weeks.

Question 30

Do I need a consultant?

Accepted Answer

No, the software is self-service with intuitive user interface. Optionally, we offer onboarding support and training.

Question 31

Are there training sessions?

Accepted Answer

Yes, extensive video tutorials, documentation and optional live training (remote or on-site). Also webinars for new features.

Question 32

Can I import data?

Accepted Answer

You can upload document files. Tenant owners can import document metadata from CSV with a preview and error check; this creates new drafts without files. Legacy-system migration and supported file formats need case-by-case assessment.

Question 33

Is there support?

Accepted Answer

Yes, email support (response within 24h), chat support (Mon-Fri 9am-5pm) and for Enterprise customers also phone support and dedicated Customer Success Manager.

Question 34

Can I export my data?

Accepted Answer

Tenant owners can export the document collection, including versions, metadata and associated files, as a ZIP with a JSON manifest. Individual PDF exports are available separately. Other QMS data and a full tenant export are not included.

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