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From record to approval.

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Every change, side by side.

Buffer Preparation · MBR v1.2 Approved
  1. 1Weigh Tris base12.10 g
  2. 2Dissolve in WFI800 mL
  3. 3Adjust pH7.4 ± 0.2
  4. 4Mix15 min
  5. 5Hold at room temperature30 min
Buffer Preparation · MBR v1.3 In review
  1. 1Weigh Tris base12.10 g
  2. 2Dissolve in WFI800 mL850 mL
  3. 3Adjust pH7.4 ± 0.27.4 ± 0.1
  4. 4Mix15 min
  5. 5Filter0.22 µm
  6. Hold at room temperature
  1. WFI volume 800 → 850 mL
  2. pH tolerance ±0.2 → ±0.1
  3. Filtration step added
  4. Hold step removed

Sample screen

Three stages. One platform.

Features covered by MBR, EBR and MES
FeatureMBREBRMES
Master recipe authoring
Review & approval workflow
Electronic signatures
Audit trail
Step-by-step execution
Review by exception
Equipment & material tracking
ERP & LIMS integration

Enterprise systems since 2008. Compliance, designed in from day one.

  • GMP
  • CSV
  • Data integrity

Built for regulated industries.

Fields our team has delivered in since 2008.

  • Pharma & Bio

    MES, MBR and EBR authoring, bioprocess systems

  • Insurance

    New business, products, GA sales, call center, digital channels

  • Banking & Securities

    Bancassurance, retirement pensions, channel websites

  • Public sector

    Next-generation core systems, EDI, facility management

Built for the rules you're audited on.

Regulations and how SilverGate addresses them
StandardRequiresHow we address it
21 CFR Part 11Electronic records & signaturesAudit trail, e-signatures, access control
EU GMP Annex 11Computerised systemsValidated system, backup, change control
GAMP 5Risk-based validationURS, FS and IQ/OQ/PQ deliverables
ALCOA+Data integrity principlesAttributable, time-stamped, tamper-evident records

How a project runs.

  1. 01

    Assess

    URS, gap analysis

  2. 02

    Design

    FS, risk assessment

  3. 03

    Build & validate

    IQ / OQ / PQ

  4. 04

    Go live

    Training, SOPs, hypercare

References

  • In progress

    Samsung Biologics

    MES MBR · PCS · EBR Authoring

    Field
    Pharma & Bio
    Scope
    Analysis, design, development
    Since
    Feb 2025

    Vue 3JavaOracleWebLogic

  • In progress

    Incheon International Airport Corporation

    IFMS Integrated Facility Management System

    Field
    Public · Airport facilities
    Partner
    Hiddenwork

Clients

  • Samsung BiologicsPharma & Bio
  • Incheon International AirportPublic sector
  • National Pension ServicePublic sector
  • Hanwha General InsuranceInsurance
  • KB Life InsuranceInsurance
  • Lina LifeInsurance

PartnersHiddenwork

Company

Name
SilverGate Co., Ltd.
CEO
Changkeun Lee
Founded
2021
Location
POSCO Tower-Songdo 26F, Incheon, Korea

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