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  • Pharmaceutical Cold Chain & GDP/GMP Temperature Monitoring

    Seemoto delivers continuous, wireless temperature and environmental monitoring for regulated pharmaceutical operations, helping manufacturers, distributors, laboratories, and logistics teams maintain product quality, meet compliance requirements, and protect patient safety across the entire cold chain. Seemoto’s system supports GDP (Good Distribution Practice), GMP (Good Manufacturing Practice), EN12830, and FDA 21 CFR Part 11 compliance with automated, audit-ready reporting and secure long-term data retention. 
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Why Continuous Monitoring Matters in Pharmaceuticals

Maintaining controlled conditions is mission-critical because:

Temperature deviations can compromise drugs, APIs, vaccines, and biologics
Manual logging increases risk of gaps and errors in regulatory records
Delayed detection can lead to product quarantine or recall
Incomplete documentation complicates audits and inspections
Offline or after-hours incidents can go unnoticed without real-time monitoring

Common Challenges in Pharmaceutical Monitoring

Manual Compliance Workload

Quality teams spend excessive time on manual logs and documentation reviews to meet GDP and GMP requirements.

Delayed Excursion Detection

Condition deviations are often discovered too late, increasing product risk and operational cost.

Audit & Documentation

Missing audit trails and inconsistent data make inspections stressful and risky.

24/7 Compliance Risk

Deviations that occur outside regular hours may go unaddressed until critical damage occurs.

What Is Monitored in Pharmaceutical Environments

Humidity

Vital for stability in environments where moisture impacts product integrity.

Temperature

Continuous monitoring for controlled rooms, cold rooms, freezers, warehouses, and stability chambers.

Real-Time Alerts

Automated notifications for excursions beyond defined thresholds.

Power Availability

Detects power interruptions that risk storage integrity. 

Door Activity

Tracks access events to support handling control and deviation investigations.

Historical Trends

Long-term data visibility supports audits, investigations, and improvement.

Seemoto Solutions for Pharma Industry

Facility & Storage Monitoring

Continuous temperature monitoring for regulated storage areas where product integrity and compliance are essential. 


Typical environments include:

• Finished goods warehouses
• API and raw material storage
• Cold rooms and ambient control zones
• Quarantine and release areas 

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R&D & Quality Control Laboratories

Monitors laboratory spaces that support pharmaceutical testing, stability studies, and analytical work requiring traceable environmental records. 


Typical environments include:

• Stability chambers
• Analytical labs
• Sample and reagent storage
• Method development labs

Manufacturing & Cleanroom Environments

Monitors controlled production areas where consistent conditions are required for GMP-driven operations. 


Typical environments include:

• Cleanrooms and classified production zones
• In-process storage and buffer areas
• Equipment and utility control rooms

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Validation & Professional Services

Seemoto supports pharmaceutical teams with wireless temperature mapping and validation services that help meet regulatory expectations for sensor placement, site qualification, and monitoring system validation.


Typical validation needs:
• Sensor mapping for controlled environments
• IQ/OQ/PQ support documentation
• Validation protocol templates and reports
• Gap analysis for existing workflows

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Biobanks & Ultra-Low Temperature Storage

Designed to protect high-value biological materials with monitoring for ultra-low temperature and cryogenic storage. 


Typical environments include:

• -80 °C freezers
• Cryogenic (LN₂) storage
• Cell and gene therapy repositories

Shipments & Cold Chain Distribution

Monitors pharmaceutical shipments from pick-up through delivery, ensuring compliance and traceability throughout transport. 


Typical use cases include:

• GDP-compliant outbound shipments
• Clinical trial material logistics
• Cross-site warehouse transfers
• Third-party cold chain partners

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​Facility & Storage Monitoring

Finished Goods Storage

Monitoring for pharmaceutical finished products stored under regulated temperature conditions to ensure product integrity and release readiness.

Typical Environments:

  • Pharma warehouses
  • Distribution centers
  • Finished goods stores

Raw Materials & API Storage

Continuous monitoring of raw materials and active pharmaceutical ingredients to maintain stability and traceability before production.                                                         

Typical Environments:

  • Raw material warehouses
  • API storage rooms
  • Quarantine zones

Cold Rooms & Ambient Zones

Monitoring for temperature-controlled and ambient storage areas used across pharmaceutical operations.                             

Typical Environments:

  • Cold rooms
  • Controlled ambient storage
  • Staging areas

Backup & Emergency Storage

Monitoring for secondary or contingency storage used during equipment failure or capacity overflow.

Typical Environments:

  • Backup cold rooms
  • Emergency storage locations

Quarantine & Hold Areas

Monitoring of segregated storage areas used for non-released, returned, or investigation-pending products.

Typical Environments:

  • Quarantine rooms
  • Deviation holding areas

Biobanks & Sample Storage

High-reliability monitoring for biological samples, reference materials, and retained samples.

Typical Environments:

  • Biobanks, R&D storage
  • retention sample rooms

​Manufacturing & Cleanroom Environments

Cleanroom Production Areas

Monitoring environmental stability in GMP cleanrooms to support product quality and process consistency.

Typical Environments:

  • Cleanrooms
  • Classified production zones

In-Process Holding Areas

Monitoring conditions where materials are temporarily stored during production workflows.

Typical Environments:

  • Buffer rooms
  • In-process storage zones

Change & Expansion Zones

Temporary monitoring for production changes, renovations, or new process introductions.

Typical Environments:

  • New production lines
  • Renovated cleanrooms

Documentation & Archive Rooms

Monitoring for environments storing controlled documentation, records, or stability samples.

Typical Environments:

  • Archive rooms
  • Controlled document storage

Quality Control Laboratories

Monitoring storage and working environments supporting analytical testing and quality control.

Typical Environments:

  • QC labs
  • Analytical labs

Equipment & Utility Rooms

Monitoring environments housing critical production equipment sensitive to temperature or humidity.

Typical Environments:

  • Equipment rooms
  • Utility areas

​Professional Services for Pharmaceutical Monitoring

Temperature Mapping & Risk Assessment

Professional mapping services to understand temperature behavior in pharmaceutical storages and production.

Typical Environments:

  • Warehouses
  • Cold rooms & cleanrooms

Validation Services (IQ / OQ / PQ)

Structured validation services to support GMP and GDP compliance for monitoring systems.

Typical Environments:

  • Regulated pharma facilities
  • Validated storage areas

Monitoring System Design & Rollout

Support for designing scalable monitoring architectures across single sites or global pharma networks.

Typical Environments:

  • Multi-site pharma organizations
  • Single-site production

Facility Changes & Expansion

Monitoring support during facility upgrades, layout changes, or capacity expansion.

Typical Environments:

  • New production zones
  • Renovated storage zones

Inspection & Audit Support

Support during regulatory inspections, audits, and internal quality reviews.

Typical Environments:

  • Pharma manufacturing storage
  • QA offices

Calibration Management

Ongoing calibration services to maintain sensor accuracy and compliance over time.

Typical Environments:

  • All regulated monitoring points

​Shipments & Goods Monitoring ​

Incoming Medicine Deliveries

Monitoring temperature-sensitive pharmaceutical products during inbound deliveries to ensure acceptance criteria are met upon receipt.

Typical Environments:

  • Pharma receiving bays
  • Inbound logistics areas

Inter-Site Transfers

Monitoring pharmaceutical products transferred between manufacturing sites, warehouses, or distribution centers.

Typical Environments:

  • Internal pharma logistics
  • Company-operated transport

Sample & Stability Shipments

Monitoring of stability samples, reference samples, and test materials during transport between sites or laboratories.

Typical Environments:

  • R&D logistics
  • QC sample transport

Returned & Reverse Logistics

Monitoring returned pharmaceutical products pending inspection, quarantine, or destruction.

Typical Environments:

  • Returns processing areas
  • Quarantine zones

Third-Party Logistics (3PL)

Monitoring shipments handled by external logistics providers to maintain visibility and accountability.

Typical Environments:

  • 3PL cold chain transport
  • Contract logistics

Export & International Shipments

Monitoring cross-border pharmaceutical shipments where temperature excursions can result in regulatory or commercial risk.

Typical Environments:

  • Air cargo
  • International freight lanes

Case Customer Highlight

Signia Logistics Peru

Signia Logistics Peru

“Seemoto ensures our warehouses stay within required temperature ranges and alerts us instantly in case of deviations. It helps us meet all audit and compliance requirements, including FDA 21 CFR Part 11.”
— José Porras, QA Instrumentation Engineer

Orimattila Pharmacy Finland

Orimattila Pharmacy Finland

“With Seemoto we monitor over 20 points in real time—including pharmacy spaces, delivery vehicles, and pickup machines. It’s effortless and gives us full confidence, even in winter transport.”
— Meri-Susanna Jänönen, Pharmacist

Commonly asked questions

Is Seemoto suitable for GDP and GMP regulated pharmaceutical environments?

Yes. Seemoto fully supports GDP, GMP, EN12830, and FDA 21 CFR Part 11 compliance with secure data logging, audit trails, 5-year retention, and validated data integrity.

What pharmaceutical environments can Seemoto monitor?

Seemoto monitors production zones, warehouses, cold rooms, refrigerators, freezers, stability chambers, cleanrooms, and transport conditions for raw materials, APIs, and finished pharmaceutical products.

Can Seemoto simplify regulatory inspections or audits?

Yes. Automated, timestamped reports and clear deviation logs simplify audit preparation and demonstrate GxP-compliant environmental control.

Does Seemoto support temperature mapping before long-term monitoring?

Yes. Seemoto supports wireless temperature mapping to identify optimal sensor locations required for regulatory guidelines. 

How scalable is Seemoto for large pharmaceutical operations?

Seemoto is highly scalable and suitable for single sites or global warehouse networks, with centralized monitoring, customizable alerts, and integrations with ERP, WMS, and quality systems

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.

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