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Solutions/IQ, OQ & PQ Services (GMP/GDP)

IQ, OQ & PQ Services
GMP/GDP Validation & Compliance

Düzenlemelere tabi ortamlar için resmi doğrulama paketleri. GxP, GDP, GMP ve FDA 21 CFR Bölüm 11 uyumluluğu için eksiksiz IQ/OQ/PQ belgeleri, doğrulama protokolleri ve denetim desteği.

GxPGDPGMPFDA 21 CFR Part 11

All Validation Service Offerings

GxP Validation

Formal GxP validation providing documented proof that the monitoring system meets regulatory requirements. Deliverables include a Validation Master Plan, IQ/OQ/PQ protocols and execution reports, risk assessments, and ongoing audit support.

GDP/GMP Documentation

GDP and GMP documentation suites covering system-level qualification: IQ (installation per specs), OQ (operation within parameters), and PQ (performance under real conditions). Includes execution records, validation reports, and SOPs.

FDA 21 CFR Part 11 Assessment

Readiness assessment for FDA 21 CFR Part 11 electronic records and signatures requirements. Includes gap analysis against audit trail, data integrity, and electronic signature requirements with formal compliance documentation.

Dahil Olan ve Eklenti Özellikleri

Standart Olarak Sunulan Özellikler

  • Validation Master Plan

    Complete validation planning documentation

  • IQ/OQ/PQ Protocols & Reports

    Full protocol and report packages

  • Risk Assessments

    Comprehensive risk analysis

İsteğe Bağlı Eklentiler

  • On-site Audit Support

    Expert support during audits

  • Annual Revalidation

    Yearly revalidation services

The Validation Process

1

Planning

Validation Master Plan defining scope, approach, and acceptance criteria.

2

IQ — Installation

Verify system is installed per specifications and documentation.

3

OQ — Operation

Confirm system operates within defined parameters under test conditions.

4

PQ — Performance

Prove system performs reliably under real-world operating conditions.

Sık Sorulan Sorular

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