Software system validation

This means we have to effectively plan the migration of data and then validate it with statistical observations once it has been imported into the new system. At Orcanos, we use a s andbox to create a replication of your production process. This allows you to test your migration process without losing downtime or having to implement any rollback procedures. The full Application Lifecycle Management ALM process must be followed when you make a change in any aspect of your system — whether hardware or software.

This process involves the following considerations: read more. Fig 4. The Orcanos system allows you to isolate the sandbox test environment from the production process. The sandbox holds a complete copy of the production data. This approach ensures no interruption for your users while you are in the process of making, verifying, and validating your changes. Your validation plan must outline each step in the testing process: from the initial requirements and intended use of the product to the functional requirements of the software.

The Orcanos system ensures a seamless migration of data. Skip to content. Search for: Search. Fig 1. Orcanos ISO Risk Management System Where existing data is impacted, we often must move or migrate data from one system to another. Fig 2. Orcanos built-in migration tools Plan and Validate Microsoft Office programs like Word and Excel are often not standardized.

Fig 3. Orcanos Sandbox replication of production The Full Lifecycle The full Application Lifecycle Management ALM process must be followed when you make a change in any aspect of your system — whether hardware or software.

This process involves the following considerations: read more Requirements Design Testing Validation Fig 4. Orcanos complete end-to-end ALM process according to IEC The Orcanos system allows you to isolate the sandbox test environment from the production process.

Validation Your validation plan must outline each step in the testing process: from the initial requirements and intended use of the product to the functional requirements of the software. It is critical to ensure that your requirements and specifications are well defined and approved before validating the computer system. The validation V-Model is commonly used to visualize the relationship between requirements and specifications and the testing performed on them see diagram below.

Qualification testing down the right side of the V is designed based on your intended use and the functionality required to meet that use represented down the left side of the V. Successful completion of the testing will verify that your system functions as intended and is fit for its intended use in your environment. It is best practice to approve your user requirements and functional specifications before testing to avoid scope creep and possible re-testing.

If your in-house staff does not have the bandwidth or experience for proper testing, you should work with qualified CSV consultants, like CSols, who have the requisite experience with your informatics systems.

The importance of laboratory informatics data cannot be understated. When you have data in a validated environment, you need to ensure that your data remain secure and reliable.

The four additions are Complete, Consistent, Enduring, and Available. Data integrity is integral to all validation activities. Although we are still waiting for the FDA to release their expected guidance about computer system assurance CSA , it is coming.

At its core, CSA reinforces a risk-based approach that expands on the GAMP 5 principles of product and process understanding, quality risk management, and leveraging supplier activities.

Risk is assessed based on the big picture of the overall business process. Doing so places more emphasis on test efficiency, focusing on testing that ensures the system is fit for purpose. Validation of computer systems can involve challenges, including the risk of system failure, restrictive company policies, and increasingly stringent regulatory requirements.

Another significant issue is when users need to balance the risk vs. Again, the degree of validation required depends on the level of risk involved. Manufacturers producing finished products for consumption or for medical use — for example, a pharmaceutical drug — have to comply with a greater amount of FDA recommendations.

Meanwhile, manufacturers who produce components of these finished products — e. The scope of your validation project will depend on where your company falls on this risk-assessment scale.

As a result, the FDA is constantly expanding its requirements to encompass more consumable products as new ones come on the market and become popular. The cannabis industry is one of the newest entrants to the consumable-goods market, along with vape and nutraceutical products.

There are many levels of testing and analysis required in the cannabis industry to ensure safety and quality, especially for medical-use products. Currently, there are no national or global regulation standards in this emerging market, given that sale and distribution is not yet legal at the federal level in many countries or within many U. However, there are an ever-growing number of states and countries legalizing or decriminalizing use. As a result, companies and consultancies are beginning to implement GMP to ensure safe use, replicable quality and compliance in the cannabis industry.

Cannabis growers and producers should validate any software system that might affect the quality of their product according to GMP standards. This includes manufacturing, production, inventory management, packaging and labeling and maintenance processes and functionality. For chemical and process manufacturers, tracking lot data from cradle to grave is the most crucial set of data that needs to be validated.

When there is a recall, you need to be able to track the lot where the problem originated, as well as to retrieve records of everywhere that lot was consumed and every purchased product it went into. Your PQ documentation should focus on the ability to record and retrieve purchasing and manufacturing transactions; to record and provide an audit trail for every inventory transaction; and to control access to inventory changes. If you produce or distribute goods in Europe, there are additional rules to comply with: The Registration, Evaluation, Authorization and Restriction REACH regulation requires chemical producers and distributors to provide safe handling information on chemical properties and register it in a central database.

Make sure to validate processes for compliance with these standards, as well. Datacor ERP is a robust, integrated enterprise resource planning ERP system that helps businesses in any industry centralize and streamline processes, but is designed with chemical and process manufacturers in mind. Datacor customers can request the toolkit here , or learn more about what Datacor ERP has to offer. Datacor offers products and services designed specifically for process manufacturers and chemical distributors.

Contact us to learn more about our products and services. Call us now at or fill out the form to the right. All rights reserved Privacy Policy. The Datacor Blog. Get in Touch. What is FDA validation? How do you validate software? Software validation best practices FDA software validation template Software validation for the chemical, manufacturing and cannabis industries What is software validation?

What is FDA software validation? Who needs to validate software? Every step of the validation process must be documented. This goes for all hardware, software, equipment and systems. These tests and results can be supplied by the vendor, since they involve standard features and security capabilities. Performance Qualification PQ : This stage confirms that the software, as it was installed, will perform the way your company needs it to.