CSV
Computer System Validation
What Is CSV?
Computer System Validation (CSV) is the activity of assuring that an IT system is designed accurately
in a consistent and reproducible way, and of establishing documented evidence for it.
Purpose of CSV
To compete internationally in the life sciences, manufacturing IT systems must meet
Global GMP Compliance such as FDA, EU EMA and ISO.
GMP Experts
Experts trained and experienced in GMP interpret regulatory requirements.
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IT SME
IT expertise in system architecture and data flow technically verifies data integrity.
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A CSV service that
systematically assures
the data integrity of computer systems
Service Areas
We design the validation scope and documentation system to fit each industry's standards.
01
Pharma / Bio
21 CFR Part 210
21 CFR Part 210
21 CFR Part 11
GAMP5
Standards Applied
02
Medical Devices
ISO 13485
ISO 14971
ISO 80002-2
Standards Applied
03
Cosmetics
FDA OTC
21 CFR Part 210
21 CFR Part 211
GAMP5
Standards Applied
Service Types
From consulting to ongoing operational support, combined to the scope you need.
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Consulting and Execution
End-to-end computer system validation
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Periodic Review
Periodic review and history management of IT systems
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Part 11 Compliance
Developing compliance plans for regulations such as 21 CFR Part 11
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Operational Support
Support for building an ongoing GMP operating framework
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SOP Development
Establishing IT quality management policies and execution plans
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PMO
Overall quality management of IT implementation projects
Systems Covered
Validation scope covers IT systems across manufacturing, quality and logistics.
ERP
Enterprise Resource Planning
LIMS
Lab Information Management System
MES
Manufacturing Execution System
SDMS
Scientific Data Management System
WMS
Warehouse Management System
CDMS
Clinical Data Management System
UDI
2D Barcode System / UDI
EDMS
Electronic Document Management System
Expected Benefits: Why RBLCM
We apply the Risk Based Lean Compliance Methodology (RBLCM), a risk-based practical execution method.
01
Risk-Based Execution
RBLCM is risk-based and optimized to demonstrate error-free data integrity within the scope of 21 CFR Part 11.
03
Efficient Resource Use
Systems are reviewed more efficiently than with the reference methodology, reducing costs.
02
Clear GAMP5-Based Phases
Procedures and deliverables are clearly defined for each phase, so a quality management system can be built to fit each client.
04
Practical Regulatory Readiness
We build a documentation system that practically meets the Global GMP Compliance required to compete internationally.
OUR CLIENT
News
Bioconnect keeps trying new things and keeps growing.
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![[News] Bioconnect Newsletter 2026 Vol.3](https://static.wixstatic.com/media/058093_cd41b2c2d2b643489dd5f1e30a268984~mv2.png/v1/fill/w_1078,h_1440,fp_0.50_0.50,q_95,enc_avif,quality_auto/058093_cd41b2c2d2b643489dd5f1e30a268984~mv2.png)
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![[News] Bioconnect Wins 3rd Place in SLW 2026 Citizen Innovation Award (Mayor of Seoul Award)](https://static.wixstatic.com/media/058093_b374a5e0975e4260a60d5d45fadb7324~mv2.png/v1/fill/w_842,h_1125,fp_0.50_0.50,q_95,enc_avif,quality_auto/058093_b374a5e0975e4260a60d5d45fadb7324~mv2.png)
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![[News] Bioconnect to Exhibit at Seocho AI Festa 2026](https://static.wixstatic.com/media/058093_01fa12807f7547019d7318acf1113c33~mv2.png/v1/fill/w_653,h_872,fp_0.50_0.50,q_95,enc_avif,quality_auto/058093_01fa12807f7547019d7318acf1113c33~mv2.png)
![[News] Bioconnect to Exhibit at Smart Life Week 2026](https://static.wixstatic.com/media/058093_d97daf9f5b7e42f08f07cbda10372dc0~mv2.png/v1/fill/w_653,h_872,fp_0.50_0.50,q_35,blur_30,enc_avif,quality_auto/058093_d97daf9f5b7e42f08f07cbda10372dc0~mv2.png)
![[News] Bioconnect to Exhibit at Smart Life Week 2026](https://static.wixstatic.com/media/058093_d97daf9f5b7e42f08f07cbda10372dc0~mv2.png/v1/fill/w_653,h_872,fp_0.50_0.50,q_95,enc_avif,quality_auto/058093_d97daf9f5b7e42f08f07cbda10372dc0~mv2.png)
![[News] Bioconnect to Exhibit at Korea Construction & Safety Expo 2026](https://static.wixstatic.com/media/058093_f26dcb035a444dc6aa819546928a0807~mv2.png/v1/fill/w_653,h_872,fp_0.50_0.50,q_35,blur_30,enc_avif,quality_auto/058093_f26dcb035a444dc6aa819546928a0807~mv2.png)
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![[Media] Bioconnect Showcases Contactless ‘VitalTracker’ at Try Everything 2026… “Making Health a Habit”](https://static.wixstatic.com/media/058093_fb195055b683413182588e4353ae897f~mv2.jpeg/v1/fill/w_749,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/058093_fb195055b683413182588e4353ae897f~mv2.jpeg)
![[Media] Bioconnect Showcases Contactless ‘VitalTracker’ at Try Everything 2026… “Making Health a Habit”](https://static.wixstatic.com/media/058093_fb195055b683413182588e4353ae897f~mv2.jpeg/v1/fill/w_1120,h_1496,fp_0.50_0.50,q_90,enc_avif,quality_auto/058093_fb195055b683413182588e4353ae897f~mv2.jpeg)
![[News] Bioconnect Newsletter 2026 Vol.2](https://static.wixstatic.com/media/058093_0f68dc494d19495fa75e0fc88c199f97~mv2.jpg/v1/fill/w_749,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/058093_0f68dc494d19495fa75e0fc88c199f97~mv2.jpg)
![[News] Bioconnect Newsletter 2026 Vol.2](https://static.wixstatic.com/media/058093_0f68dc494d19495fa75e0fc88c199f97~mv2.jpg/v1/fill/w_1120,h_1496,fp_0.50_0.50,q_90,enc_avif,quality_auto/058093_0f68dc494d19495fa75e0fc88c199f97~mv2.jpg)