Software Requirements for Cleanroom Environmental Conditions Monitoring

To ensure compliance of your software installation, it is helpful to use the GAMP 5 approach to choose and qualify the software installation used for the cleanroom environmental system. Good Automated Manufacturing Practice (GAMP) is a guidance tool used to achieve compliant computerized systems. The tool provides systematic validation in the life cycle model to produce quality pharmaceutical equipment. Most pharmaceutical suppliers use GAMP in drug distribution as part of the FDA regulations.

Cloud or On-Premises

The choice of data storage location is a technical question, which you can answer based on relevance. Cloud storage is offsite data storage where another person or entity is responsible for data security and management. On-premises data management means that all IT infrastructure is in-house, with an internal resource in charge.

Each data management approach has its merits, demerits, and different software requirements. In determining the choice between cloud and on-premises data management, the size of the facility and sensitivity of the data gathered matter. Such information is crucial and helps understand the user requirements specifications and the choice of data management software.

Applying this concept in a cleanroom monitoring system requires customized software to match the needs. Some of the areas of concern are temperature, humidity, carbon (IV) oxide, atmospheric pressure, and cleanliness. Assembling all these factors would need different requirements, which makes the project complex but essential.

SaaS (Cloud)

Software as a Service (SaaS) is a data distribution and management model where the cloud service provider hosts applications and avails access to the database over the internet. Only authorized persons can access the database, making it secure. However, there are several topics within SaaS which experts are trying to address. They revolve around encryption, security monitoring, data residency, and incidence responses.

Latest Functions and Features

SaaS has made strides in the recent past on data management. Some of its latest security features include:

• Data in-transit protection using the Transport Layer Security. It includes client-service protection and protection between microservers.

• API authentication and protection.

• Multi factor authentication, which reduces data theft.

Easy to Use and Maintain

Despite the strict security feature configurations, using SaaS as a client is easier. Cleanroom monitoring system administrators can scale its usage, enabling them to access more or fewer services based on demand.

The latest system version has an auto-update feature, which reduces the operation cost.

Furthermore, you can customize SaaS to fit into any user requirements specifications.

Save Resources

Most SaaS service providers have a subscription model, which is affordable. Data managers save funds that would have gone into software purchase, installation, and other complementary software. There is no need for manual reporting and regular checks since the system is set to observe compliance. From automated warnings to alarms, the system handles the integral cleanroom monitoring aspects.

Flexibility

Software managers can customize it to fit any user requirements specifications. It manages data excursions and can build user profiles on individual use (e.g., depending on cleanroom shifts).

 

Practical Guide on Cleanroom Monitoring

What you should know about monitoring parameters in pharmaceutical cleanroom production.

 

 

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On-Premises

If you have an in-house data server, it comes with several elements. An on-premises data management system works well with big IT companies, as they can effectively manage the process. Consider the following on-premises system elements when looking into this option:

1. Unstable internet - If you cannot rely on the internet to send data, the on-premises system transmits data in a closed system, which doesn't depend on the internet.

2. Complete control - Using an on-premises data server gives you complete control over the IT infrastructure. The system administrator has exclusive access to the database and infrastructure and can customize it to suit the purpose.

3. Security risk - With total control comes responsibility. The company is responsible for IT and data security. Since the servers are physically installed, the company should have physical and cybersecurity technicians to protect them from vandalism and intrusion. If someone can penetrate the system's vault and plant a harmful device, it can destroy or erase any data stored in the servers. Also, any physical attack on the premises is detrimental to data security.

4. Avoid possible data loss - Chances of data loss are possible since everything is in one place. You need to ensure that a backup process is in place.

5. Software updates - The software cannot always be up-to-date since any upgrades require physical installation and maintenance. Outdated software may lead to cybersecurity attacks since hackers capitalize on the system's vulnerability to access the database.

6. Resources and time - Installing physical servers is expensive and time-consuming. The developers have to fortify the location before bringing in the equipment. If you add this to the cost of setting up a cleanroom monitoring system, the total running cost will be high.

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Key Strategies in Software Development

There are 5 key strategies developers use to come up with cleanroom software. Each strategy handles a phase in the development stage, as explained in the steps below.

Step 1: Formal Specification

The user requirement specification guides the system configuration. Consider the size of the cleanroom in your plan, and zero down on hardware and software needed for the project.

Step 2: Incremental Development

This is the first unit testing of the system to quantify the system’s design specification. If it passes the test, the developer can go to the next stage. If not, the process starts all over again.

Step 3: Structured Programming

The next step is configuration, which is configuring the software into the cleanroom monitoring system. Verification, in this case, identifies the behavior of the software within the system. It must match the configuration testing to scale. If it works, the process moves to the next step.

Step 4: Static Verification

This is the functional testing of the complete cleanroom monitoring system. This step verifies its workability, with a specific focus on environmental monitoring. You need sample pharmaceutical products to test the system.

Step 5: Statistical Testing of the System

After certifying the first 4 steps, there is a final system requirement testing to verify every stage in the build-up. The developer once more goes through the user requirement specifications and certifies the system for operations.

GAMP 5

In pharmaceutical engineering, GAMP 5 is the risk-based approach used in ensuring GxP compliance in computerized systems. It analyzes category risks to validate the system and forms the basis for the cleanroom monitoring system validation. The validation points out any risk in the environmental monitoring process. The procedure takes a V-shape, with verification steps in the three pharmaceutical engineering categories.

Category 3: Non-Configured Products – comprises products or software with only one configuration.

Category 4: Configured Products – the products can change their initial configuration to match user specifications.

Category 5: Custom Applications – the category looks into specialized software development processes used by regulated organizations. Pharmaceutical companies fall under this category, as their manufacturing and distribution are highly centralized.

Summary

Cleanroom monitoring is a highly guarded project which requires specific conditions. The holding facility should have pre-defined requirements for cleanroom environmental monitoring. Software systems in cleanroom monitoring facilities have properties you can choose from based on your specifications. For expert guidance on monitoring solutions, reach out to ELPRO and benefit from their experience in qualification and environmental monitoring for healthcare and pharmaceutical products.