What is Computer Software Validation and Why Do You Need It?

Computer Software Validation
Data protection and network security concept. Glowing light Shield on business woman hand for internet fire wall protect, insurance, or computer virus cleaner.

Implementing Computer Software Validation requires proper knowledge and guidance. If you’re wondering whether your company needs CSV or not, what are the benefits of CSV, this post will provide answers to all your questions.

What is Computer Software Validation?

Before starting, it is important to know how the Food & Drug Administration (FDA) and other regulatory bodies define computer systems. If you are a business manager of a start-up, you need to expand the scope of the term beyond a PC and the software suite installed on the device.

Computer systems come with all the complementary equipment that supports the entire system and its users. In terms of software, Computer Software Validation is a method that helps businesses to successfully complete the tasks a system was designed for, have strong control over user operations and their security. CSV activities include

  • Specifying the needs of users
  • Defining functional requirement specs
  • Creating a validation plan
  • Writing operational qualification scripts
  • Maintaining system release documentation

Who Needs CSV?

Computer system validation is a method to avoid profit loss and business risks. In short, it can be life-saving. For example, detecting medication defects can help in preventing unfortunate side effects as well as avoid certain damage a drug consumer would have otherwise received. Hence, it is an obligatory stage for companies. Check out the lists of businesses that are enforced to conduct CSV:

  • Pharmaceutical: In the United States and most developed companies, pharmaceutical industries have to undergo CSV. If you belong to this industry, you need to validate your system if your business produces drugs that are used for diagnosing or treating diseases.
  • Storage and distribution providers: There are several businesses that store pharmaceuticals, biologicals, or cell-and-tissue products. They are obliged to complete CSV. Otherwise, they have to pay penalties.
  • Products that sell biologicals: Products can be referring to biological if they are made from a therapeutic serum or a virus and can be used for injury or disease prevention as well as treatment. Vaccines are biologicals as well.
  • Medical devices distributors: Medical devices comprise of instruments that can be used for diagnosis, treatment, or to prevent illnesses. Some of the examples are lasers, medical implants, tongue depressors, thermometers, and prosthetics.

Why Do You Need Computer Software Validation?

Companies aim to create goals, culture, management, processes, and incentives that build infrastructure. Computer software can increase part of business infrastructure. CSV is the process validation and comes with several benefits:

  1. Excellent ROI: The cost of compliance is low with the potential loss of intellectual property or other potential losses.
  2. It provides the documentation required by the Food & Drug Administration, other regulatory agencies, and your customers.
  3. It enhances the value of the computer system and the employees that use it.
  4. It eliminates labor costs by increasing employee efficiency as well as effectiveness.
  5. It boosts project management to make sure projects are implemented on schedule and within budget.
  6. It allows saving money by discovering defects early before failures occur in production.
  7. It eliminates risks. Software is made and used by humans. So, it is guaranteed to be imperfect. Software and process defects enhance with software complexity. Computer systems are accurate for their purpose and operating properly in order to represent good business practice.
  8. It promotes continuous process improvement. Software is evolving to keep up with the complex needs of the people that use it. Hence, validation is an ongoing necessity.

To experience such benefits, you need Computer Software Validation (CSV) for your business.


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