GxP Validation
IQ, OQ & PQ Services (GMP/GDP)
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.
End-to-End GxP System Validation
Pharmaceutical and biotech manufacturers face regulatory pressure to prove their monitoring infrastructure is fit for purpose before product is placed at risk. Without a complete validation package, inspectors can reject monitoring data as inadmissible evidence during audits or product release reviews. Seemoto's GxP Validation service delivers the full documentation chain — from master plan through executed IQ/OQ/PQ — so your monitoring system carries regulatory weight from day one.
How it's deployed
Validation is scoped to your specific site: sensor placement is mapped against thermal risk assessments, gateway coverage is verified against installation specifications, and each IQ/OQ/PQ phase is executed on the live system under real facility conditions. Risk assessments (FMEA) are embedded at each phase to justify the scope and acceptance criteria, following a phased approach aligned with GAMP 5.
Evidence & Reporting
Deliverables include a Validation Master Plan, phase-specific protocol documents, signed execution reports with raw test data, deviations log with impact assessments, and a final Validation Summary Report. All documentation is structured to satisfy GxP inspections by regulatory bodies including EMA, WHO, and national competent authorities. Change control and re-validation triggers are documented in accompanying SOPs.
Included and Optional Capabilities
Included
- Validation Master Plan
Complete validation planning documentation
- IQ/OQ/PQ Protocols & Reports
Full protocol and report packages
- Risk Assessments
Comprehensive risk analysis
Optional add-ons
- On-site Audit Support
Expert support during audits
- Annual Revalidation
Yearly revalidation services
Related IQ, OQ & PQ Services (GMP/GDP) Offerings
Frequently Asked Questions
The Validation Master Plan defines the scope, strategy, roles, acceptance criteria, and schedule for all three validation phases specific to your monitoring installation. It is drafted by Seemoto's validation specialists and requires approval from your Quality Assurance team before execution begins, ensuring alignment with your internal quality management system.
For a single-site pharmaceutical warehouse, the process typically spans four to eight weeks depending on the size of the installation and the availability of your QA personnel for protocol review and sign-off. PQ duration is driven by your internal requirement for the performance observation period, which is commonly 30 days of continuous operation.
Not necessarily — additions are handled through a formal change control process that assesses impact on the validated state. If new sensors or zones are added within the original validated design parameters, a supplemental qualification (delta validation) covering only the changed elements is typically sufficient.
Plan GxP Validation
Talk with Seemoto about the sensor, gateway, reporting, and compliance setup for gxp validation.