Continuous validation: A framework to eliminate re-mapping

In regulated environments like GxP, temperature validation can come with challenges: Time-consuming processes disrupting operations, costly re-mappings, and the struggle to keep up with validation schedules across facilities.

The continuous validation framework offers an alternative to traditional temperature validation. On this page, you can learn how the method works, the key benefits, and the steps to make it part of your operations.

We will go through:

• What is continuous validation?
• Differences between traditional validation and continuous validation
• Key steps of the continuous validation framework
• The benefits of continuous validation
• 8 pitfalls to avoid when establishing a continuous validation setup

What is continuous validation?

Continuous thermal validation, ongoing verification, continuous qualification – one concept, many labels.

Despite its various names, this framework may be unfamiliar. Although it is mentioned briefly in the International Society of Pharmaceutical Engineering’s (ISPE) “Controlled Temperature Chamber Mapping” (referring to the framework as “continuous verification”), the method is not widespread.

Within GxP environments, thermal validation or mapping involves confirming that a temperature-controlled unit, facility, or process is appropriate for its intended use and adheres to specific requirements at a particular time. Continuous validation is an approach that enables ongoing validation of these conditions.

Also read: What is the difference between mapping and validation?

The difference between traditional validation and continuous validation

Traditional validation is a snapshot, confirming that a unit or facility works as intended at a particular moment. Since conditions and systems change over time, this method requires periodic re-validation. This time-consuming, costly process can be a struggle to keep an overview of, especially when running multiple more or less autonomously run facilities.

The continuous validation framework is designed to address this issue: By establishing a monitoring setup that provides ongoing insights into the facility's performance, the method enables continued verification of these conditions to be integrated as a part of daily operations, thereby eliminating the need for re-validation.

Also read: When should you do a re-mapping?

Example: Traditional vs. continuous validation

Let us try to compare traditional and continuous temperature validation with a concrete example.

Traditional validation

1. Initial validation: You conduct a full mapping study, mapping out the entire usable value to understand the airflow and conditions. For this, you use 100 data loggers. Based on this study, you determine your extremes – hot and cold spots – and some operational risk zones, such as doors and gates.
2. Ongoing monitoring: Using the findings from the initial validation, you locate your absolute risk zones where you permanently place 5 data loggers for monitoring. This way, you cover your extremes, ensuring that everything in between will be within limits.
3. Re-validation: In a couple of years, you have to re-validate your facility to determine if there are any changes to the conditions, meaning that you have to redo step 1 with all 100 data loggers, which is time-consuming and expensive. You also have to keep up with the validation schedule – sometimes even for multiple facilities.
4. Re-validation – again: A couple of years later, you do it again. And again. And again.

Continuous validation

1. Do a risk assessment: The framework is based on a risk-based approach; therefore, you start by assessing and understanding your risk zones and use this assessment to determine all other steps – more on this in the upcoming sections.
2. Initial validation: You determine that to cover your risk zones, you can settle for installing only 20 data loggers and use them for your mapping – note that for larger facilities, you still might need to do the full mapping study as an initial step – we will come back to that in the next section.
3. Ongoing monitoring and validation: Now, you keep those 20 data loggers permanently in the facility for continuous monitoring and validation.
4. You are done: You are now constantly covering all risk zones and won’t have to do a full validation again unless you change the operation.

The steps of the continuous validation framework

Time to dive into the different steps of continuous validation in more detail. How do you actually implement a continuous validation method in your operation?

Step 1: Risk assessment time

First things first: The whole framework is based on working risk-based. You need to understand and consider your risks every step of the way. And this starts with a thorough risk assessment.

Why do you need a risk assessment? The risk assessment both works as a blueprint for establishing a setup suitable for your conditions and forms the documented rationale for your setup. This way, it serves as evidence to auditors that the setup is well-thought-out and lives up to your requirements.

Guidelines for conducting risk assessments in continuous validation At Eupry, we believe in a risk-based approach when planning and carrying out any type of validation – continuous or traditional. Therefore, we have developed a framework for identifying and categorizing risks. These categories are the same as for traditional validation and mapping.

At a high level, you should consider these three risk types when developing your risk assessment:

• Compliance risks: These are the most straightforward risks to identify since they are based on the fixed requirements mentioned in the standards and regulations relevant to your operation. For instance, you must know your hot and cold spots, do seasonal mappings if your facility is affected by outside conditions, do regular re-mappings, etc.
• Technical risks: These risks arise from the technical installations in the room or unit. This could be the ventilation system: Where is it placed, and in what direction does the air come out? In a larger facility, you might have robots, lift trucks, and similar that generate heat themselves and through their charging stations. Anything technical might pose a risk that needs to be taken into account.
• Operational risks: The risks posed by the way your operation is run, for instance, where the gates or doors are located, how often they are opened, how personnel react in the facility or use the unit, how many hours of operation you have, etc. Since all operations differ, this category is not defined by any standard.

Based on these categories, your facility, requirements, and operation, you can define your risk spots and then cover those risk zones in step 2.

Note: This risk-based approach to mapping can also be utilized for traditional validation procedures.

Step 2: If the facility is new – conduct an initial mapping

When following the continuous validation framework, the first step is identical to traditional validation: Before you take a new facility into use, you need to perform an initial validation.

Tip! If you have already conducted this validation, you can skip to step 3.

There are two approaches to take based on the type and size of the facility:

1. The full – risk-based – mapping study:

You can conduct a full mapping study. This includes installing data loggers across the entire usable volume to map out the conditions across the complete facility. The output is a range of specific risk zones – cold spots, hot spots, etc.

2. The partial – risk-based – mapping study:

Whereas a full mapping is required to uncover all risk zones for larger facilities, the same might not be needed for smaller facilities.

Another approach is using your risk assessment to identify key risk zones before mapping and then installing a smaller amount of data loggers covering these areas – contrary to every single data point within the usable volume. Focus on key areas: near the door, in front of the ventilation system, the furthest point from airflow, and diagonal corners.

When applicable, this targeted approach reduces the number of data points while ensuring thorough coverage.

How do you know if you need a full or partial mapping study for your initial validation?

The short version is that it depends on your facility and comes down to your risk assessment. To be fully compliant, you need to know your risk zones. For larger facilities, you will most often need to conduct a full mapping to locate these areas. Still, the partial process can be sufficient for smaller setups because smaller volumes give you a better capability of initially identifying risk zones.

<u>Example</u>: If you have a symmetrical unit made up of a few cubic meters, with one door and one ventilation system, then you can cover that door, the area in front of and the area furthest away from the ventilation system, one top corner, one bottom corner, and then oppositely do a diagonal. This way, you end up with fewer loggers than you would for a full mapping, but the risk assessment you have done will be reasonably comprehensive.

Step 3: Define a monitoring setup that enables continuous validation

Temperature monitoring is a requirement for any temperature-controlled environment within GxP – and where the continuous validation framework primarily stands out from traditional methods.

Simply put, continuous validation involves strategically placing more data loggers than traditionally would be the case for continuous monitoring.

This way, the methodology provides both:

• A strong foundation for monitoring, enabling you to track conditions and act on deviations.
• Coverage that lives up to the requirements of validation, continuously gathering data to validate the environment as part of your daily operation.

How to determine the number and placement of data loggers for continuous validation?

Back to your risk assessment. Essentially, you should conduct the same assessment as in the partial mappings study in step 2 to define the exact number and ideal placement of data loggers needed to monitor and validate your specific conditions. If the partial mapping study was part of your initial validation, you can simply leave the same loggers in place for continuous monitoring and validation.

Example: A traditional monitoring might require five data loggers placed in primary risk zones, whereas continuous validation setups could require 15-20 placed in all risk zones.

Step 4: Continue to monitor and analyze data

Instead of doing periodic re-validation, the framework allows you to verify performance on an ongoing basis – but to do this, you need to monitor and analyze the data. Make sure you establish a process to evaluate your unit or facility's reliability on an ongoing basis – and to clearly outline this procedure in your risk assessment.

Psst… With Eupry’s continuous validation setup and mapping software, you can easily monitor performance and export a full mapping report with just a few clicks without needing to be on-site, add more loggers, or do manual data analysis. Talk to one of our specialists to learn more.

Note: No size fits – or keep fitting – all. Make sure you continuously review your risk assessment.

Potential step 5: Actually do a re-mapping

Although the continuous validation framework will significantly minimize the need for re-mappings, the process is still needed in some situations.

How to determine if you need to do a re-validation

If your operation changes, the risk might change with it. Therefore, the general requirements are that if you make changes to the operation or facility that could affect the airflow, you might need to re-validate (which is also a requirement for traditional validation setups).

What is a significant change?

The hardest part will often be determining if a change is significant enough to require a re-validation. Small changes might have significant effects, and seemingly large changes might not.

Once again, it is about having a risk-based approach and conducting a risk assessment of the alteration and whether or not it will affect airflow. You will not have to re-validate if you can show that the airflow and conditions are the same.

Example #1 – shelves: Introducing new shelves is an example of an action that could obstruct the airflow, which would make the existing measurement points unreliable and require re-validation to define new risk zones. However, suppose the shelves are hollow or made of a material with high thermal conductivity (allowing heat to transfer effectively). In that case, they might not disrupt airflow, and you may not need to re-validate.

A way to determine this would be to place a few data loggers on each side, below, and above the shelf and measure temperatures for a period – before you install it. Afterward, compare the data to check if the air conditions have changed. If not, re-validation is unnecessary, and you can document this finding in your risk assessment.

Example #2 – ventilation system: A seemingly minor change that will require re-validation is upgrading your ventilation system. Even if the new system is more efficient and reliable, and the change does not directly impact daily operations, the ventilation system is the core of a thermal space, and it would be challenging to justify skipping a full re-validation of the facility.

Also read: When should you do a re-mapping?

The benefits of continuous validation

The continuous validation framework makes it possible to ensure that your facilities continuously live up to requirements without the need for periodic re-mapping studies.

For most setups, this will mean:

• You get two for one: The setup provides a strong foundation for monitoring and coverage that lives up to the requirements of mappings.
• Less disruptions and fewer resources: Your operation will not be disrupted by periodic re-mappings, and the workload tied to quality tasks will be minimized.
• Your setup is always audit-ready: You can ensure continuous GxP compliance and consistently be prepared for audits.
• Take proactive action with better data: By moving beyond traditional limited data logger usage, you get comprehensive data that can be used for trend analysis, to make proactive decisions about facility improvements, and to improve your processes.
• Cost-effectiveness over traditional methods: Compared to running periodic re-validations, continuous validation will, in most cases, reduce labor and resource intensity and, therefore, be significantly more manageable and cost-effective. At the same time, by focusing on critical areas when applicable, the initial validation becomes more cost-efficient.
• No keeping up with validation schedules: Continuous validation eliminates the need for re-validations (unless operations are changed), meaning that you no longer need to worry or spend time keeping up with validation schedules across sites. This can be a headache if you run multiple facilities that are more or less autonomously run due to a lack of central visibility into each facility’s quality levels and often unharmonized processes.

In other words, the continuous validation method can both ensure compliance and quality by minimizing the risk of issues going unnoticed and missing validation deadlines, as well as transform validation from a disruptive, periodic event into a seamless, integral part of the operational process.

8 pitfalls you should avoid when establishing your continuous validation setup

Some of the biggest potential pitfalls to the continuous validation framework are:

1. Misjudgment during risk assessment: Determining the correct number and placement of data loggers can be a challenge, especially in facilities with irregular layouts, and failure to accurately map risk zones might undermine the entire setup.
2. Resistance to change: Stakeholders accustomed to traditional validation methods may resist adopting a new approach, and insufficient training on the new framework can result in implementation challenges.
3. Underestimating operational changes: Misinterpretation of when re-validation is necessary can result in issues. Seemingly minor changes might result in large effects on airflow, and failing to re-validate when these changes happen can lead to compliance issues.
4. Placing too many loggers: Continuous validation requires strategic placement of loggers, but overplacement can lead to unnecessary data collection, time spent on analysis, and costs.
5. Dependence on _the wrong _technology: Reliance on technical systems and equipment is always a risk if these fail or are not properly maintained. Make sure to choose a reliable solution.
6. Insufficient justification: Regulators may not be familiar with the framework, leading to questions during audits that you need to be able to answer. Therefore, it is important to have clear, documented rationales for the method (which would be the case for traditional methods decisions, too).
7. Failure to maintain risk-based documentation: Continuous validation depends on a well-documented risk-based approach, which requires ongoing updates to remain relevant. Operations change, facilities experience tear, and businesses evolve; as such, you can and should never consider your risk assessment “done”. Review and update it regularly to make sure it still reflects your actual, current risks.
8. Not staying alert: Using the continuous validation setup can become a complacency trap where temperature compliance is parked in the “taken care of” pile – but things change, and failing to periodically review the framework could lead to outdated risk assessments and vulnerabilities.

Eupry continuous validation service

• Eliminate disruptive re-validations across sites
• Conduct mappings with one click in the software
• Reliable wireless equipment designed for GxP

By utilizing our wireless data loggers, extensive experience with validation in GxP, and specialized validation software, Eupry’s continuous validation solution ensures that your operations continuously live up to GxP requirements without the need for disruptive re-mapping studies.

Book a talk with one of our specialists to learn more or download a solution catalog: