跳至主要内容
CDMOEurope & Switzerland

Owner capex control from construction through equipment qualification.

CapCon links costbook, construction programs, equipment qualification, and GMP change control in one audit-ready layer — complementing your QMS and MES, not replacing them.

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CDMO capex must tie to qualification — not just WBS lines.

When equipment release, validation, and change control live outside project controls, audits find gaps between construction and QA.

  • Equipment traceability gaps

    CapEx spend is hard to connect to asset qualification status and release decisions.

  • Construction vs. GMP change

    Construction change orders and GMP change controls run in separate tools without a bridge.

  • Validation package friction

    IQ/OQ/PQ evidence is scattered when project and QA systems don't share context.

  • Audit readiness

    QA needs exportable history for change control — not screenshots from construction trackers.

Construction ↔ GMP

One hub from capex to qualified equipment.

CapCon bridges construction change orders, forecast/SOV equipment links, and GMP change control workflows — with impact analysis and e-sign approvals.

01

Capex & equipment

Investments traced to equipment master, cleanrooms, and qualification matrix.

02

GMP change control

Impact analysis, approval workflow, and audit export — QMS-compatible boundaries.

03

Quality & validation

Deviation/CAPA mirror, GMP reports, and clear scope vs. Veeva/MasterControl/TrackWise.

CDMO journey

Equipment → change control → audit export

The Bachem-style walkthrough: portfolio manufacturing view, CO with equipment impact, and approved GMP CC.

  • Equipment-linked forecast and open change controls.

  • Construction change spawns linked GMP workflow.

  • Filterable history for validation evidence.

CDMO capabilities

From owner capex to GMP sign-off

Core construction and costbook control first — GMP change control, qualification, and QMS bridge where regulated manufacturing requires them.

  • Owner capex & costbook

    Budget, commitments, and forecasts for construction programs — traceable to equipment and asset lines.

  • Construction change orders

    Approved COs with forecast impact and equipment links — documented from request to portfolio view.

  • Equipment release

    Release and quarantine states with auditable events on the asset.

  • GMP change control

    Submit → impact analysis → approve with e-sign → audit CSV export.

  • Construction ↔ GMP bridge

    Create linked GMP change controls from construction CO detail — bidirectional navigation.

  • IQ / OQ / PQ matrix

    Qualification status per equipment line — aligned with validation records.

  • Deviation & CAPA mirror

    Read-sync from QMS — mirror only, not a full quality system replacement.

  • GMP reports

    CSV/text exports for validation packages and QA review.

CDMO · Europe

Finally a path from construction change to GMP sign-off without re-keying impact in three systems.

— QA lead, peptide CDMO (Europe)

仅供说明的示例引述，并非经核实的客户评价。

  • CO ↔ CC

    Linked change bridge

  • IQ/OQ/PQ

    Qualification matrix

  • Part 11

    E-sign readiness

Europe

For CDMO and GMP manufacturing capex

Project controls, engineering, and QA teams investing in European and Swiss production and fill-finish capacity.

  • Project controls

    Construction COs, forecast/SOV equipment links, capex traceability.

  • QA / validation

    Change control approval, impact analysis, validation package exports.

  • Engineering

    Equipment master data, MES event triage, qualification status.

GMP enterprise

Validation-friendly, QMS-aware

CapCon complements your existing quality stack with clear boundaries for regulated European and Swiss deployments.

  • 21 CFR Part 11 readiness

    Electronic signatures and immutable snapshots on regulated actions.

  • Audit trail export

    Filterable manufacturing change-control history for QA evidence.

  • QMS complement

    No full QMS or EBR replacement — bridge construction and GMP.

  • GDPR & Swiss hosting

    EU/CH-aligned data protection for enterprise buyers.

Validation scope and Part 11 depth depend on deployment — we align in the pilot workshop.

GMP CCIQ/OQ/PQPart 11 readinessQMS complement

See the CDMO capex → GMP loop live.

We'll demo equipment-linked forecast, construction CO bridge, and GMP approval on the CDMO reference pack.

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Or contact our team at contact@capconhq.com