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Temperature mapping buyer’s guideline for GxP

Buying mapping services or equipment?

Make an informed decision and avoid costly purchasing mistakes – know what to look for BEFORE you buy. Here is what matters most.

There is no question: Temperature mapping is a need-to-have for GxP-regulated industries like healthcare logistics and pharma.

But, selecting the right temperature mapping solution or service provider is not always easy.

  • Should you outsource your temperature mapping and validation or handle it in-house?
  • What should you look for when selecting a service provider – and how about when choosing mapping equipment?
  • And how do you ensure the solution is compliant with your specific requirements?

Whether you are looking for equipment for conducting in-house mapping or considering outsourcing (some or all of) your validations to a service provider, this guide will help you make the optimal decision for you.

Why temperature mapping and validation matter in GxP

Regulatory bodies like the FDA, EMA, and WHO require organizations handling temperature-sensitive products to prove that their storage and transport environments are validated to maintain the correct conditions.

This is where mapping comes in. It is the process of testing and documenting the environmental conditions within a storage facility, warehouse, cold room, or transport container to confirm that temperature and humidity remain within required limits.

Learn more here: "Temperature mapping: Tips, frameworks, and pitfalls"

Download the full temperature mapping buyer’s guide

Download the full version of the “Temperature mapping buyer’s guideline for GxP” – a step-by-step guide to help you make an informed decision and avoid costly mistakes.

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Should you handle temperature mapping in-house or outsource it?

One of the biggest decisions you will need to make is whether to invest in in-house temperature mapping equipment or outsource the process to a service provider. Each approach comes with advantages and trade-offs.

The in-house approach

Many companies conduct temperature mapping internally using USB or wireless data loggers. This approach can work well if you have the necessary expertise and resources. On the other side, it can take time away from operation for your internal staff and requires dedicated personnel that has the needed training and regulatory knowledge.

The outsourced approach

Some organizations choose to outsource all or part of their temperature mapping to specialized service providers. This can be a good option for companies that lack internal resources or need to meet strict validation deadlines. It comes with the benefit of having an expert-led process that gives confidence in the reliability of the study, a reduced operational burden, and often faster turnaround. On the other hand, it can require higher upfront costs compared to in-house mapping and require a diligent vetting process to find a suited service provider.

Download the mapping buyer’s guide to learn more about how to spot the right temperature mapping provider for your needs.

The hybrid approach

Many companies take a hybrid approach, where in-house staff work together with external providers. Sometimes in a remote version, sometimes “routine” validations are handled internally, and complex or large-scale projects are outsourced to service providers.

What to consider when selecting temperature mapping equipment or services

Regardless of whether you handle mapping in-house or outsource it, selecting the right equipment and/or service provider is important.

Making the right decision requires balancing cost, compliance, and operational efficiency.'

Choosing temperature mapping equipment

If you chose the in-house route and need to select temperature mapping equipment, here are some things to consider:

  • Compliance: Does the equipment meet GxP, FDA, EMA, and ISO requirements?
  • Ease of use: Is the system user-friendly, or will it require extensive training?
  • Data integrity: Does the system provide secure and traceable records?
  • Real-time monitoring : Can you track temperature fluctuations as they happen?
  • Calibration requirements: How often does the equipment need calibration, and is this process efficient?
  • Cost-effectiveness: Is purchasing equipment the right long-term investment, or would a rental or outsourced solution be better?

Choosing mapping service providers

If you chose to outsource some or all of the mapping, it is important to find a service provider who matches your needs.

When evaluating a temperature mapping service provider, look for:

  • Industry expertise

    Do they have experience in GxP-regulated environments?

  • Regulatory knowledge

    Can they ensure compliance with FDA, EMA, WHO, and ISO standards?

  • Flexibility

    Can they adapt to your specific storage and transport conditions?

  • Efficiency

    How quickly can they complete the validation process?

  • Ongoing support

    Do they provide training, consultation, or continuous monitoring options?

  • Equipment

    Do the vendor bring their own equipment and, if so, of what quality is it?

  • Reporting

    How will reporting be done? Does it match your processes?

  • Approach

    Do the vendor work with a risk-based approach to mapping?

Download the full buyer's guide

With so many factors to consider, making the right decision can be tricky. The buyer’s guide is designed to help you make an informed decision and choose the best mapping solution for your operation.

With the guide, you will:

  • Understand the different mapping options available to you
  • Find the most cost-efficient and compliant solution for your needs
  • Avoid the common mistakes that lead to compliance failures and inefficiencies

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