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SilverBio Author

From record to approval.

Sample screen

Audit trail

Every action, on the record.

Sample screen

E-signature

Signed to Part 11.

Sample screen

SilverBio Compare

Every change, side by side.

  1. Batch record
  2. Cleaning SOP
  3. QC specification
Buffer Preparation · MBR v1.2 Approved
  1. 1Weigh Tris base12.10 g
  2. 2Weigh NaCl8.77 g
  3. 3Dissolve in WFI800 mL
  4. 4Adjust pH7.4 ± 0.2
  5. 5Mix15 min
  6. 6Hold at room temperature30 min
Buffer Preparation · MBR v1.3 In review
  1. 1Weigh Tris base12.10 g
  2. 2Weigh NaCl8.77 g8.80 g
  3. 3Dissolve in WFI800 mL850 mL
  4. 4Adjust pH7.4 ± 0.27.4 ± 0.1
  5. 5Mix15 min20 min
  6. 6Check conductivity14–16 mS/cm
  7. 7Filter0.22 µm
  8. Hold at room temperature
  1. NaCl 8.77 → 8.80 g
  2. WFI volume 800 → 850 mL
  3. pH tolerance ±0.2 → ±0.1
  4. Mixing time 15 → 20 min
  5. Conductivity check added
  6. Filtration step added
  7. Hold step removed
Equipment Cleaning · SOP v4.0 Approved
  1. 1Pre-rinse with purified water5 min
  2. 2Detergent concentration1%
  3. 3Wash temperature60 °C
  4. 4Final rinse3 cycles
  5. 5Air dry overnight12 h
Equipment Cleaning · SOP v4.1 In review
  1. 1Pre-rinse with purified water5 min
  2. 2Detergent concentration1%2%
  3. 3Wash temperature60 °C70 °C
  4. 4Final rinse3 cycles
  5. 5TOC swab test≤ 500 ppb
  6. 6Visual inspection sign-offQA
  7. Air dry overnight
  1. Detergent 1% → 2%
  2. Wash temperature 60 → 70 °C
  3. TOC swab test added
  4. QA visual check added
  5. Overnight drying removed
Tablet Release · Specification v2.0 Approved
  1. 1AppearanceWhite, round
  2. 2Identification (TLC)Conforms
  3. 3Assay95.0–105.0%
  4. 4Dissolution, 30 minQ = 75%
  5. 5Hardness8–12 kp
Tablet Release · Specification v2.1 In review
  1. 1AppearanceWhite, round
  2. Identification (TLC)
  3. 2Identification (HPLC)Conforms
  4. 3Assay95.0–105.0%97.0–103.0%
  5. 4Dissolution, 30 minQ = 75%Q = 80%
  6. 5Hardness8–12 kp
  7. 6NDMA impurity≤ 0.03 ppm
  1. TLC identification removed
  2. HPLC identification added
  3. Assay range tightened
  4. Dissolution Q 75 → 80%
  5. Nitrosamine limit added

Sample screen. Tap a template or a change to explore.

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

Questions we hear most.

  • Yes. It is designed for Part 11 from the start: every action is kept in an audit trail, records are signed electronically at author, review and approval, and access is controlled by role. The same design covers EU GMP Annex 11 and ALCOA+ data integrity.

  • MBR is the master batch record: authoring the recipe and getting it reviewed and approved. EBR runs that record on the floor, step by step, with review by exception. MES adds equipment and material tracking and connects to ERP and LIMS.

  • Four steps. Assess: URS and gap analysis. Design: FS and risk assessment. Build and validate: IQ, OQ and PQ. Go live: training, SOPs and hypercare. Deliverables follow GAMP 5.

  • SilverBio Compare puts two versions side by side and lists every value change, addition and deletion, for batch records, cleaning SOPs, QC specifications and other templates. Try the sample above.

  • Yes. Since 2008 the team has delivered systems for insurance, banking and securities, and the public sector, including an integrated facility management system for Incheon International Airport.

  • Send an inquiry with the form below or book a 30-minute meeting on Google Meet. We will start from your current process and documents.

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

PartnersHiddenwork

Company

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

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