Warehouse qualification guidance GxP

Warehouse monitoring & mapping

For GDP-regulated storage & distribution

Reduce the risk of non-compliance and lost products in your life science holding and storage applications areas with the viewLinc Continuous Monitoring system:

  • Easy connectivity - wired/PoE and wireless VaiNet data loggers provide connectivity for versatile installation
  • 24/7 remote alarming via SMS, email, or local signal tower alerts
  • Custom reports can be automated and delivered by email on demand, or scheduled
  • Comprehensive IQOQ validation documents
  • On-site installation/validation services available
  • Indigo80 Hand-held indicators can be used for spot-checking and on-site calibrations
  • Simplified warehouse mapping solutions. Save time and costs qualifying storage areas with Vaisala's Mapping kit 
  • Mapping services available in selected regions
  • Choose from viewLinc Enterprise Server Software for on-premises or viewLinc Cloud.
    viewLinc CMS

For Commercial storage & distribution

Jade Smart Cloud monitoring system ensures the quality of stored goods, such as electronics, perishable goods, food & beverage, high-quality mechanical and aerospace products and other valuable items:

  • Long product lifespan minimizes the total cost of ownership
  • Long-term record of measurement data for reporting on storage conditions
  • Easily scalable for a variety of storage applications
  • Data securely stored in the cloud, reducing IT load
  • 24/7 remote alarming via SMS & email
  • Superior long-range LoRa® based VaiNet radio technology for reliable monitoring
  • Easy addition of new loggers and access points enables effortless system expansion
  • Accurate data based on Vaisala HUMICAP® proven sensor technology
  • Indigo80 Hand-held indicators can be used for spot-checking and on-site calibrations

Jade Smart Cloud

9 Steps to GxP-compliant Warehouse Mapping

Create a validation master plan

Create a validation master plan

Establish a validation plan that takes a risk-based approach. Where will environmentally sensitive products and materials be stored?

Identify areas at risk

Identify areas at risk

Identify risk from variations in temperature and humidity. Account for : 

  • Volume of space 
  • Temperature gradients 
  • Energy sources (heaters, AC, fans) 
  • Shelving layout 
  • HVAC control locations 
  • High traffic areas 
  • Seasonality 
  • Location to external exposure
Develop protocol information

Develop protocol information

Based on identified risks, make decisions on what your data needs are for your mapping study.

Determine sensor distribution

Determine sensor distribution

How can we create a uniform distribution of sensors that will give us a full understanding of the environment? Take into consideration external walls, windows, lighting, and any type of air circulation. Storage shelf capacity has an effect on airflow and temperature gradients. Will humidity have an adverse effect on products? Consider using both temperature and humidity sensors.

Select suitable technology

Select suitable technology

Choose equipment designed for mapping studies. 

  • Software that meets all 21 CFR Part 11 & International standards 
  • Temperature only 
  • Temperature and Humidity 
  • High-accuracy measurement range 
  • Long-term stability 
  • Traceable calibration 
  • Clear, comprehensive and accessible records
Set up mapping equipment

Set up mapping equipment

Setup sensors where planned

Test and review data

Test and review data

Conduct a test and look at data for these points: 

  • Dates and times 
  • Calculated values (temp. min/max, avg.) 
  • Review trends over time 
  • Instrument settings 
  • Traceable calibration 
  • Calibration info 
  • Review and approve report
Document and schedule mapping study

Make modifications

Identify locations where products may be exposed to unacceptable conditions, then make adjustments to storage locations. Don't forget to modify your validation protocol in light of results from initial mapping test.

Make modifications

Document and schedule mapping study

Conduct and document a mapping study for approval then plan out mapping schedule.

Warehouse monitoring and mapping products

Jade Cloud Solution

Jade Smart Cloud

Combining industrial-grade measurements with secure and reliable wireless monitoring, Vaisala Jade Smart Cloud brings new levels of proficiency and flexibility for professionals.
Indigo520 with probe

Indigo500 Series Transmitters

The Vaisala Indigo500 series transmitters are host devices for Vaisala Indigo-compatible, stand-alone smart probes. The Indigo500 series include multi-functional Indigo520 transmitter and Indigo510 transmitter with basic features.
DL2000

Temperature and Humidity Data Loggers DL2000

The Vaisala DL2000 data logger uses highly calibrated temperature and humidity sensors to provide accurate and stable measurement, with an optional analog input channel for other parameters and door contacts. The latest generation is the VDL200 data logger.
DL1016-DL1416

Temperature Data Loggers DL1016/1416

Vaisala's multi-application temperature data logger monitors temperatures in up to four applications with one logger – ultra-low temperature freezers, freezer/refrigerators and incubators.
Vaisala DL1000-1400 is a high-accuracy temperature data logger. Ideal temperature logger for ultra-low temperature regulated environments.

DL1000-1400 Temperature Logger

Vaisala DL1000-1400 is a high-accuracy temperature data logger. Ideal for ultra-low temperature freezers, fridges, cold rooms in regulated environments, the DL1000-1400 temperature logger provides stable, reliable measurements.

Customer cases

Cleanroom, incubator, storage area, fridge monitoring system for GxP
Customer Case

New cleanrooms at NorthX Biologics prompts search for better monitoring system

During preparations for the construction of two new cleanroom facilities, NorthX Biologics, a leading Swedish biological drug manufacturer and process developer, reviewed its environmental monitoring and control procedures, and decided to switch to a new Vaisala system, including almost 150 monitoring locations within cleanrooms and associated facilities.

Insights from our experts

Building Automation Scheme
Application note

Challenges in Multi-Site GxP Monitoring

In this application note, we classify the common issues in multi-site environmental monitoring systems into five broad types: Security, Administration, Geographic Variation, Multiple Site Types, and IT Infrastructure. 

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