Participates in Manufacturing AI+ Festa at 'SME Innovation Week 2026' from Nov. 18 to 20
Unveils 'ELNpro GxP AI' based on electronic lab notebooks... Streamlines documentation and data retrieval under regulatory environments
Enhances data security by running on closed networks without external LLM API calls... Demonstrates key functions and conducts 1-on-1 consultations
PageOne (CEO Seong Ho-kyung) is set to present 'ELNpro GxP AI,' an artificial intelligence (AI) solution designed to support research and quality documentation drafting and data retrieval in the pharmaceutical and biotech sectors.
PageOne announced on November 9 that it will participate in the Manufacturing AI+ Festa at 'SME Innovation Week 2026' (K-INNO WEEK), held from November 18 to 20 at Cheongju OSCO in North Chungcheong Province. Selected as an AX (AI Transformation) pavilion exhibitor, PageOne will set up a booth to demonstrate the actual system and conduct one-on-one business consultations.
Organized by the Korea Technology and Information Promotion Agency for SMEs (TIPA), the Manufacturing AI+ Festa is an event designed to share AI transformation (AX) technologies and achievements in smart factories and manufacturing sites while facilitating B2B matching.
Supporting Everything from Research and Quality Documentation to Source Retrieval
ELNpro GxP AI is a GxP-specialized AI solution based on PageOne's Electronic Laboratory Notebook (ELN), engineered to assist in pharma and biotech R&D and quality control record-keeping.
GxP refers to regulations and quality standards that must be complied with across drug R&D, clinical trials, manufacturing, and quality control processes. In the pharma and biotech industries, records must be documented according to designated procedures and templates, and companies must be able to swiftly verify data creation and modification histories for internal audits and regulatory inspections.
To reduce the time spent on such documentation and search tasks, PageOne implemented draft lab notebook generation and integrated report creation features. Users can draft lab notebooks or consolidate multiple lab notebooks into draft reports using AI. Through a natural language-based Audit Trail query function, users can also track when specific data was generated or modified.
Human Approval with Evidence Traces Instead of Autonomous AI Decision-Making
According to the company, ELNpro GxP AI is designed to allow human users to review AI-generated results while preventing arbitrary changes to existing data. It provides document numbers and rationale paragraphs from relevant regulations alongside drafts so users can verify result validity. While AI handles data retrieval, summarization, and drafting, final verification and approval remain the responsibility of human operators.
For data queries, read-only access modes and separate security mechanisms were implemented to restrict unauthorized modifications of existing records and unnecessary command execution. Instead of calling external Large Language Model (LLM) APIs, the solution operates self-hosted AI models within a closed-network GPU environment.
PageOne explained that applying AI to regulated pharma and biotech environments requires clear roles and authorizations alongside formal review procedures for generated outputs. At the 'Data Integrity Forum 2026' held in conjunction with 'KOREA LIFE SCIENCE WEEK 2026' last September, the company introduced an operational structure where AI integrates into existing systems without major disruptions, with human operators making final decisions after validating generated outputs.
Hands-On Natural Language Data Search... 1-on-1 Consultation Zone
The exhibition booth will consist of an introductory zone presenting key messaging and technology, a demonstration zone for showcasing actual ELNpro GxP AI interfaces, and a 1-on-1 consultation zone.
In the demonstration zone, visitors can experience querying research data or audit trail records using natural language prompts. PageOne will also demonstrate drafting customized lab notebooks matching in-house templates, verifying source documents, generating consolidated draft reports, and searching rationale paragraphs within Standard Operating Procedures (SOPs) and relevant regulations. To protect client confidentiality, sample demo data will be used on-site instead of real customer data.
Seong Ho-kyung, CEO of PageOne, said, "The primary reason pharma and biotech companies hesitate to adopt AI is concern over data integrity and regulatory compliance. ELNpro GxP AI was engineered to keep data internal while leaving clear record and rationale traces, making it an AI solution QA and QC personnel can use with confidence." He added, "At this Manufacturing AI+ Festa, we will demonstrate what practical manufacturing AX tailored for regulated industries looks like."
Since its founding in 2015, PageOne has provided end-to-end services in the pharma/biotech GxP system field—ranging from solution development and implementation to Computer System Validation (CSV) and operations. The company was rated 'Excellent' in the 2025 Smart Factory Provider Competency Assessment and was named among the 'TOP 50' in 2025 and 'TOP 20' in 2026 in the Manufacturing AI Solution Contest.
