# Cersys AI

> Cersys AI is a regulatory compliance software based on AI, developed by GEM4 Technologies SL, that helps industrial quality and compliance teams interpret technical regulations, manage customer-specific requirements, and generate compliance documentation with verifiable traceability to the original source text. It uses a RAG (Retrieval-Augmented Generation) architecture that vectorises standards, customer specification documents, tables, annexes and diagrams, anchoring every answer to the exact source fragment. Customer data is never used to train models and each documentary base is kept isolated per organisation.

Cersys AI assists and accelerates the quality team but does not replace professional judgement: final interpretation, validation and sign-off always rest with the quality or compliance team. Its differentiator versus generalist LLMs is the use of RAG over the customer's own private standards and documents, with source traceability and NDA confidentiality.

## Pages

- [Cersys AI – Home (Spanish)](https://www.cersys.ai/): Main page describing the product, use cases, sectors and FAQs.
- [Cersys AI – Home (English)](https://www.cersys.ai/index-en.html): English version of the main page.
- [GEM4 Technologies](https://www.gem4tech.com): Company behind Cersys AI.

## Core capabilities

- Interpretation of technical regulations with verifiable traceability to the original text
- Compliance documentation generation in editable Word and Excel
- Multi-standard regulatory analysis and cross-referencing
- Indexing and querying of customer-specific requirements under NDA
- Version control support for customer specification documents
- Conflict and prevalence analysis between customer requirements and standards
- RAG architecture over standards, customer documents, tables and diagrams
- Multilingual: query in the original language, answer in the team's language

## Target users and industries

- Users: quality managers, regulatory affairs teams, compliance teams, product and systems engineers
- Industries: automotive, medical devices, pharmaceutical, industrial manufacturing / machinery, aerospace, food industry

## Supported standards (examples)

- ISO 9001, ISO 13485, IATF 16949, MDR, ISO 14971, IEC, UNE
- GMP / GxP, HACCP / IFS, CE marking (European directives and regulations), VDA standards

## Customer requirement documents

- Customer specific requirements (CSR)
- Customer specification documents / cuadernos de cargas (automotive)
- User Requirement Specification (URS) – machinery and equipment
- Quality requirement specifications (QRS)
- Related deliverables: PPAP, APQP

## Data and privacy

- Customer documents and conversations are never used to train AI models
- Each customer works with an isolated documentary base
- Data Processing Agreement (DPA) and NDA available
- GDPR-compliant, EU-aligned data handling

## Common questions answered

- What is AI-based regulatory compliance software?
- How does a RAG system support regulatory compliance and avoid hallucinations?
- What is the difference between ChatGPT and AI compliance software?
- Can AI manage customer-specific requirements (CSR), cuadernos de cargas and URS?
- What happens when a customer requirement conflicts with the standard? (prevalence)
- How do you keep track of the different versions of customer specifications?
- How do you know which customer requirements apply to a specific product or project?
- Can AI generate compliance documentation conforming to standards?
- Does AI replace the quality or compliance team? (No — the final decision stays with the team)
- How can AI help with ISO 9001, IATF 16949, ISO 13485 + MDR, GMP, HACCP/IFS and CE marking?