The software validation process ensures that the system fits the intended functions and uses. The computer system validation is essential since it ensures the safety of the products for consumers through the regulation of the process. It is vital to let experienced and skilled professionals execute the computer system validation, given its importance and necessity. The experts will help improve the efficiency and quality of your system. Also, they will ensure the systems are compliant with methodology development.

Understanding the Computer System Validation Basics

Computer system validations discussions are not termed as complete without considering the legislation around them. For instance, in the United States, the FDA regulates particular industries that directly impact consumers’ health, including beverages, cosmetics, food, and pharmaceuticals. These particular industries are supposed to be responsible for ensuring the products they provide are safe for use by individuals.

 Notably, the legislation comes from the code of Federal Regulations in the US that deals with electronic signatures and records. These regulations and rules also apply in other countries.

The requirements for electronic signatures and records should be considered reliable, accurate, readily retrievable, and secure to replace handwritten signatures and legally paper records. Validating the company’s computer system is a significant way of determining that the users can use electronic signatures and records.

The Computer System Validation Process

Computer system validation can take many shapes depending on whether there is an upgrade to the existing system or new implementation in the computer system life cycle. For an existing computer system that is expanding the scope of its intended use or needs an upgrade, it is required to keep the system validated through testing the new capabilities before allocating them to production use. Notably, the validation process ends when all the data has been transferred to the new system. However, for new computer systems, the validation starts from the ground since the user hopes to solve the current problem in the computer system.

What Is A Validation Master Plan?

The user validation master plans help through the computer system validation process to ensure that everything on the check-off list happens in the required way. The validation master plan then encompasses the other necessary steps to ensure the system becomes validated and fit for its intended use.

Notably, the validation master plan should account for a functional risk assessment, requirements gathering, IQ OQ PQ protocols, a trace matrix, and testing. Also, the validation master plan should account for change control procedures and should be executed in the defined order. Suppose the user wants to minimize the risk of going back to create new test cases during the validation process. In that case, they should complete the risk assessment and requirements before developing the trace matrix or testing.

The Computer System Validation Challenges

Computer system validations may involve a lot of challenges for the process to be successful. The process may have a lot of risks, including restrictive company policies, system failure, and other major stringent regulatory requirements. Also, when users need to balance between the cost of the equation and the risks after the risk categories are defined, it poses a significant risk of the computer system validation. However, there are effective ways to remedy these challenges and risks involved in the validation process. The risk-based approach to mitigate these challenges include:

  • By ensuring the validation master plan follows industry-best regulations, practices and is also complete.
  • By providing acceptable results, that is by giving clear limits of the expected results.
  • By defining the computer system requiring validation, including hardware, people, software, and processes.
  • By meeting and describing through specifications and requirements for the intended use of the computer software.

Notably, the computer system validation process can be challenging and complex. It is wise to let an experienced and highly knowledgeable expert handle the entire process. It would also be vital to consult a professional to know if the in-house staff has the required computer system validation experience.

The Meaning of Computer System Assurance

Computer system assurance is a risk-based approach introduced by the FDA to limit testing functions directly that impact consumers’ safety and product quality consumed by people. Computer system assurance also encourages organizations to reduce the testing burden by deploying applications faster using the software vendors’ documentation. Computer system assurance acts as the new technique of critically looking at the traditional computer system validation to ensure the safety of the consumer is met.