Est. 2019 · Pharmaceutical research, development, technology & contract services · Hyderabad, India sales@dgxpcompliancelab.com Careers

Capability

Technology Design, Build, Test & Verify

Engineering pharmaceutical technology the way it will be inspected: requirements first, designed and built to them, then tested and verified with evidence.

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Engineer operating a process vessel through its HMI touchscreen
Engineers reviewing equipment parameters during qualification

What we do

Automation and computerised systems in GxP areas need a traceable path from user requirement to verified release. We work across that path — specification, design review, integration, testing and qualification — following a GAMP 5 risk-based approach.

System build and integration may involve equipment vendors and system integrators. DGXPComplianceLab leads requirements, risk assessment, test strategy and documentation, and coordinates the engineering partners.

Where it fits in the pharmaceutical lifecycle

Typical activities

Each activity shows who performs it. We do not claim facilities we do not own.

DGXP-led Led by the DGXPComplianceLab team Partner-coordinated Performed by a qualified partner, coordinated by us

  • PLC

    Partner-coordinated

    Control logic requirements, alarm philosophy and interlock verification.

  • HMI

    DGXP-led

    Screen design review, user access levels, audit trail and electronic records.

  • SCADA

    Partner-coordinated

    Data acquisition, historian configuration and reporting.

  • Automation

    DGXP-led

    Equipment automation strategy and integration architecture.

  • Manufacturing systems

    Partner-coordinated

    Process equipment and control systems in production areas.

  • Laboratory systems

    DGXP-led

    Instrument software, CDS and LIMS interfaces.

  • Digital workflows

    DGXP-led

    Replacing paper steps with controlled electronic workflows.

  • Data systems

    DGXP-led

    Data flow mapping, historian and reporting design.

  • Electronic documentation

    DGXP-led

    Electronic records and signatures per 21 CFR Part 11 / EU Annex 11.

  • Integration

    Partner-coordinated

    Interfaces between equipment, MES, LIMS and ERP.

Design · Build · Test · Verify

The same engineering discipline applies whether the system is a PLC-controlled machine or a laboratory workflow.

Design

  1. Requirement (URS)
  2. Functional design
  3. Technical design

Build

  1. Development
  2. Configuration
  3. Integration

Test

  1. Testing (FAT / SAT)
  2. Verification
  3. Qualification (IQ / OQ / PQ)

Verify

  1. Validation
  2. Documentation
  3. Release

Pharmaceutical examples

  • PLC
  • HMI
  • SCADA
  • Automation
  • Manufacturing systems
  • Laboratory systems
  • Digital workflows
  • Data systems
  • Electronic documentation
  • Integration

Technology lifecycle

  1. 1Requirement
  2. 2Design
  3. 3Build
  4. 4Test
  5. 5Verify
  6. 6Deploy
  7. 7Maintain

Technologies and processes

  • GAMP 5 (2nd ed.)
  • ISA-88 / ISA-95
  • URS / FS / DS
  • FAT / SAT
  • IQ / OQ / PQ
  • Traceability matrix
  • OPC UA

Example projects

Illustrative use cases showing how this capability is typically applied.

All projects

Our project execution model

Every engagement follows the same eight steps, scaled to the size and risk of the project.

  1. 01

    Understand

    Understand business and technical requirements.

  2. 02

    Assess

    Assess scientific, technical, regulatory and operational requirements.

  3. 03

    Design

    Design the appropriate solution.

  4. 04

    Identify

    Identify appropriate internal and external capabilities and partners.

  5. 05

    Execute

    Coordinate and execute the project.

  6. 06

    Verify

    Test, verify, qualify or validate where applicable.

  7. 07

    Document

    Create technical, quality and regulatory documentation.

  8. 08

    Improve

    Monitor, optimise and continuously improve.

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Frequently asked questions

Do you write PLC code?

Control-system build is done by system integrators and equipment vendors. We define requirements, review designs, plan testing and verify the result.

What is the difference between verification and validation here?

Verification confirms each requirement is met (testing against specifications). Validation confirms the system is fit for its intended use in the GxP process, supported by documented evidence.

Do you follow GAMP 5?

Yes — risk-based, scaled to system category and impact, with critical thinking over document volume.

Discuss a technology & engineering requirement

Share the product, stage and timeline. Capability is confirmed after technical assessment and partner availability.

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