Seemoto for qualification, documentation, and compliance readiness
Ready to qualify faster and reduce audit risk? Talk to a specialist about your units, scope, and required documentation.
What IQ, OQ, and PQ mean
IQ (Installation Qualification): Verify the system is installed correctly and documented properly.
OQ (Operational Qualification): Verify the system operates as intended across defined operating ranges.
PQ (Performance Qualification): Verify performance under real use conditions, including typical loads and workflows.
Why it matters
IQ, OQ, and PQ create the documented evidence chain that supports compliant operation. Without it, deviations are harder to investigate, audits become stressful, and expansions slow down.
The problem
The process is often slow and fragmented
Many organizations face the same issues when qualifying fridges, freezers, cold rooms, stability chambers, warehouses, and other controlled environments:
Documentation takes too long: Protocols, test plans, deviations, and final reports consume weeks of internal effort.
Operational disruption: Teams must coordinate access, scheduling, and re testing while keeping operations running.
Inconsistent methods: Different sites and vendors create variation that increases audit risk.
Data integrity concerns: Unclear record control, missing audit trails, or poor traceability create compliance exposure.
Result: delayed go live, higher cost, and avoidable findings during inspections.
The Seemoto approach
One provider, one consistent qualification model
Seemoto delivers a structured IQ, OQ, PQ service package designed for regulated operations.
Standardized qualification templates aligned with GMP and GDP expectations
Clear acceptance criteria tied to your URS and operational requirements
Traceable evidence with controlled documentation and versioning
Practical execution designed to minimize disruption in active sites
This can be delivered as a complete turnkey engagement or as modular support, depending on your internal capability and regulatory context.
How the service works
1. Scope and requirements alignment
Define the unit or area to qualify
Confirm intended use, risk level, and acceptance criteria
Align documentation expectations and timelines
What we qualify
Typical units and controlled environments
Medical and vaccine refrigerators
Laboratory freezers, including ultra low temperature storage
Cold rooms and walk in storage
Stability chambers and incubators
Controlled warehouses and distribution areas
Production adjacent controlled zones
If you have multiple similar units across sites, we can standardize the qualification approach to reduce cost and cycle time.
Where this is used
Common qualification triggers
New equipment introduction or replacement
Site expansion or new storage rooms
Change control events, such as layout or set point changes
Audit findings related to documentation gaps
Transition to GDP or GMP operations
Key outcomes for each decision maker
Quality Assurance and Compliance
Consistent, audit ready evidence set
Clear traceability from URS to acceptance criteria to results
Reduced inspection stress through standardized reporting
Operations and Facility teams
Lower disruption through planned execution
Faster commissioning of new units and expansions
Practical deviation handling and corrective action workflow
Management
Shorter time to compliant operation
Reduced internal workload and external audit risk
Repeatable model that scales across sites
Professional services options
Choose the engagement model that fits your organization
Option 1: Turnkey on site qualification
Seemoto executes IQ, OQ, and PQ and delivers the final report package.
Option 2: Remote guided qualification
Seemoto provides protocols, guides your team through execution, and produces the analysis and report.
Option 3: Documentation and QA support only
Seemoto delivers protocol templates, review support, and report structure so your team can execute internally.
Compliance alignment
Seemoto supports qualification work in environments governed by:
GMP: controlled production and quality systems
GDP: compliant distribution and storage
FDA 21 CFR Part 11: data integrity and electronic records expectations (when applicable)
EN 12830: where temperature monitoring device compliance is required in cold chain contexts
This page is not a regulatory interpretation. Final compliance responsibility remains with the regulated organization.
From Mapping to Continuous Monitoring
Seemoto allows organizations to extend temperature mapping into long-term continuous monitoring, using the same wireless infrastructure.
This ensures:
Continuous compliance between validation cycles
Immediate alerts during temperature excursions
Long-term trend analysis and early risk detection
Mapping becomes part of an ongoing quality strategy rather than a recurring operational burden.
Ready to qualify faster and reduce audit risk? Talk to a specialist about your units, scope, and required documentation.
Commonly asked questions
Let's Design Your Monitoring Setup
Whether you're monitoring a cold room, a pharma trailer, or a mobile cooler, Seemoto brings real-time insights and automated compliance to every part of your cold chain.