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Principles of Software Validation

Written by: Karleen Radke

Principles of Software Validation

The world is increasingly globalized, which leads to greater regulatory requirements imposed by both governments and standards-based organizations. Functionality, data integrity and security are some of the most important factors businesses need to keep in mind. When companies use software to fulfill regulatory requirements, they will save resources. Here, we will re-examine our previous blog series in which we looked at the factors involved with risk assessment and the principles of software validation.Principles of Software Validation_IQS

What is risk based software validation?

Despite the name, risk based software validation is not really about software. Software validation, as we perform it in today's environment, has as much to do with your business management processes as it does the software. Part of software validation is understanding how the software you have chosen interacts with company processes and knowing what risks are involved with using that software. Because of the many changes taking place across industries that must use compliance software, understanding processes is crucial for success. With a thorough understanding, you can have a better overall idea of what your business requires and avoid needless regulatory penalties. The validation process will help you make these changes, ensuring your company is ready to meet the needs of its market.

What is involved with starting software validation?

Having a solid foundation for your validation will help ensure that everything goes more smoothly. Mapping out your business' various processes and the software interface points will make it easier to start the validation process. Deal with the most critical needs first to make certain that everything works as it should.

Risk assessment

The risk assessment part of the validation process flows from addressing the software touch points. Being able to discern possible risks will help your team make informed choices about how to address these issues. A unified method of coping with risks will help make all the difference when a failure occurs or is likely to occur. When developing a risk assessment strategy be sure to keep these points in mind:

  • One size does not fit all situations. Take the time to consider the best option for each risk.
  • The solution you choose must be easy to implement under any circumstances

Knowing what risks are most likely to affect your industry or specific projects will help provide a lot of clarity. Having the tools to make everything go as smoothly as possible provides a streamlined experience for all.

Tailored software validation

One common mistake that many organizations make is thinking that scripts their vendors provide can help validate software most effectively, without the need for a specialized solution. The biggest problem with this approach is that your software configuration is likely to have changed since installation, making some aspects of your original validation irrelevant. Part of a successful validation process includes developing protocols that are specific to your system. Once you've taken steps to improve your validation process, you'll find the full procedure easier. Ultimately, everything comes down to choice: correcting the problem before it becomes an issue or waiting until the issue presents itself to correct the problem. When your company uses a better approach to risk assessment software validation, you will be more likely to see positive results and enjoy lower costs. Even though it might seem like there is a lot to do, you will be thankful for the good results that come about after validating your software. Your business' good health could depend on it.ERP and Software Validation_IQS