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How to Prepare for the Interview of Computerized System Validation?

Before getting into the meaning of CSV, it’s crucial to understand how the Food & Drug Administration (FDA) define computer systems.

“CSV is a systematic process that involves a number of critical and important activities during the product life cycle, verifying that the final product quality complies according to regulatory requirements and will produce information or data that meets defined requirements.”

The list of CSV activities usually consists of:

  • Specifying user requirements
  • Defining functional requirement specifications
  • Creating a Validation Plan
  • Writing Operational Qualification (OQ) Scripts
  • Maintaining system release documentation

Who needs Computer System Validation?

  • Pharmaceutical companies: In the US and most developed countries, pharmaceutical businesses have to undergo CSV. In particular, they need to validate their system if their business produces or distributes drugs used for diagnosing or treating diseases. 
  • Storage and distribution providers: Businesses that store pharmaceuticals, biologicals, or cell-and-tissue products are obliged to complete CSV. Otherwise, the penalties might be as high as debarment or a criminal prosecution. 
  • Products that sell biologicals: A product can be defined as biological if it’s made from a therapeutic serum or a virus and used for injury or disease prevention and treatment. Vaccines are biologicals too. 
  • Medical devices distributors: By definition, medical devices comprise of any instruments used for diagnosis, treatment, or prevention of illnesses. The most common examples of such are lasers, medical implants, tongue depressors, thermometers (only medical), and prosthetics. 

Benefits of CSV:

  • Legal compliance with the FDA: after completing Computer System Validation, companies will be able to provide regulatory organs with all the needed documentation.
  • Reduces compliance risks: Having empirical evidence of the fact that the system works as expected comes in handy during the inspections from regulatory organs. 
  • Discovers defects before a system build goes live: This way, pharmaceutical companies can avoid image losses or fraud. 
  • Provides companies with continuous improvement: Validation is a necessity for companies that constantly scale and add new features as it allows the development team to prevent tech debt from piling up. 
  • Maximizes system efficiency: If companies have validated systems, a business manager increases its future value and the efficiency of employers that use it. In the long run, CSV reduces both operating and labour costs. 

Computer System Validation check list:

  • Planning: at this stage, a company manager establishes the deadlines and the budget needed to carry out Computer System Validation. Also, all stages are broken down by time and monetary estimates. 
  • Defining user requirement specifications: Basically, this includes all the functions a system needs to carry out. 
  • Design specifications: At this point, a team involved in CSV decides the look of a given function and the way it should function in order to complete all tasks outlined during the previous stage. 
  • Configuring a system build: This stage consists of writing configure scripts that will design the software for a computer system. 
  • IQ tests: A testing team runs a range of scripts to determine if they have chosen the correct way to install the system into the user environment. 
  • PQ tests: a CSV engineer has to test worst-case scenarios to ensure a system would still work properly under poor conditions. 
  • Reporting: All planned activities are reviewed. A tester has to document the result of validation and organizes them as proof that a system is ready for release. 

Examples of Computer System Validation:

  • Control systems: The technology stack of modern control software is extremely broad — there are sequential function charts, function blocks, ladder logic, and so on. That’s why it’s wise to use a matrix-based documentation system to validate such systems. 
  • Clinical, laboratory, or manufacturing database systems: Now, when the use of wearables to collect medical data is almost commonplace, there’s a lot of data systems have to manipulate and store. That’s why validating database systems requires constant innovation. The good news is, there is no lack of disruptive CSV practice. A group of Japanese scientists, for instance, has suggested a way to validate clinical database systems that use wearable by creating a custom data-flow model. 
  • Manufacturing execution systems: MES is a dynamic environment — that’s why, during validation, developers pay extra attention to assessing the performance of its workflows. Manufacturing execution systems are often tested by the configurable manufacturing models. A CSV engineer has to assess and approve of alternate paths, step-by-step operator procedures, dispense specs, and so on. The validation process has to enforce the security and compliance of an MES. 
  • Laboratory data capture devices: Validating data capture systems, testers rely heavily on Good Automated Laboratory Practices and the National Environmental Laboratory Accreditation Conference

Automated laboratory equipment: The process of automated equipment validation consists of quality control checks, sustainability tests, the validation of analytical methods, and the qualification of analytical instruments. 

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