Exhibitors Search
GAMPLAB Inc.
Booth no.
E32
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Exhibition
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|KOREA LIFE SCIENCE |
|---|---|
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Country
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| Korea, South |
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Address
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|232 Sandan-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea |
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Tel
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|+82-31-494-8892 |
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Exhibits
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| E-Signature, Data Integrity Solution, Computer System Validation |
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Company Type
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| Digital Health / Medical Device Company , Quality Control / Analytical Instrument Company , etc(AI) |
Exhibitor Information
GAMPLAB Inc. specializes in Computerized System Validation (CSV) with a focus on data integrity, and is your data integrity partner for the AI era. We provide CSV, Data Integrity (DI) and GxP compliance consulting and practical training for the pharmaceutical, biotechnology, medical device and cosmetics industries, backed by more than 15 years of field experience and over 180 validation projects.
Guided by GAMP principles and a risk-based approach, we support validation and documentation throughout system implementation, operation and change, from laboratory and production equipment to IT solutions, and we develop our own data integrity software built on that consulting experience.
Combining an understanding of regulated environments with IT expertise, we develop practical approaches tailored to each client's systems and workflows, helping organizations build trustworthy data management practices while addressing compliance and operational efficiency.
Guided by GAMP principles and a risk-based approach, we support validation and documentation throughout system implementation, operation and change, from laboratory and production equipment to IT solutions, and we develop our own data integrity software built on that consulting experience.
Combining an understanding of regulated environments with IT expertise, we develop practical approaches tailored to each client's systems and workflows, helping organizations build trustworthy data management practices while addressing compliance and operational efficiency.
Exhibit Description
GAMPLAB is a GxP solution and AI transformation consulting firm that performs CSV from equipment to systems, with data integrity built in.
We validate embedded software in laboratory and production equipment as well as IT solutions such as EMS, BMS, LIMS and EDMS using a GAMP risk-based approach (CSV, CSA), and for new equipment we deliver the instrument, IQ/OQ and data integrity configuration in one package.
Our software includes DICAM, a timestamp camera app that stamps the photographer and capture time into photo records, an e-signature solution, and ValidCore, an AI agent-based validation management platform being prepared for launch.
Data integrity assessments and practical training complete the offering: your data integrity partner for the AI era.
We validate embedded software in laboratory and production equipment as well as IT solutions such as EMS, BMS, LIMS and EDMS using a GAMP risk-based approach (CSV, CSA), and for new equipment we deliver the instrument, IQ/OQ and data integrity configuration in one package.
Our software includes DICAM, a timestamp camera app that stamps the photographer and capture time into photo records, an e-signature solution, and ValidCore, an AI agent-based validation management platform being prepared for launch.
Data integrity assessments and practical training complete the offering: your data integrity partner for the AI era.
Individual Exhibit/Technology Introduction (Detailed)
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Product Name : DICAMDICAM (Data Integrity Camera) is a timestamp camera app that brings data integrity to photo records at GMP sites. At capture, the photographer, device number, raw data number and time are rendered into the image as a tamper-evident record. It offers user login with role separation, SHA-256 hashes and capture history; photos stay on the device. Suited to microbiological testing, environmental monitoring, appearance inspection, stability studies and cleaning validation. Free on Google Play and the App Store. An on-premise edition on your server or NAS adds audit trail, searchable history and automated evidence reports.
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Product Name : ValidCoreValidCore is an AI agent-based validation management platform being prepared for launch by GAMPLAB. It manages computerized system validation (CSV) deliverables such as VP, URS, risk assessment, FDS, IQ, OQ, PQ, RTM and VSR as structured data by project and exports them as standard documents. AI agents draft documents from GAMPLAB's 15-year validation library, while review and approval remain with people. It is designed so that evidence capture, result recording and e-signature are completed on site on test day, and is being built as a GxP system with audit trail and role-based access control. The exhibition presents the product concept and key screens.
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Product Name : USIGN E-SignatureUSIGN is an electronic signature solution developed by Korea Corporate Security and deployed at GMP sites by GAMPLAB as an official partner. Built on AATL-certified digital certificates with RFC 3161 timestamps and long-term validation (LTV), signed documents can be verified for integrity on opening, even offline, and private keys are protected in an HSM server. Its FDA 21 CFR Part 11 feature records the signer's name, organization, signing time and reason in the document, blocks changes after signing, and provides multi-factor authentication and an audit trail. Available as cloud, API or on-premise deployment, it fits GxP document workflows such as validation deliverables, SOPs and record approvals. GAMPLAB supports requirements definition, deployment and validation.
KYUNGYON EXHIBITION CORP.
