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What is computer system validation?

Computer system validation (CSV) is a method of testing, validating, and officially documenting that a regulated computer-based system performs as intended in a consistent, accurate, secure, reliable, and traceable manner.

csv in pharma

This process is used to replace paper or handwritten signatures with electronic data in highly regulated environments that impact public health and safety such as the pharmaceutical and medical device industries. These industries rely on computer systems to manage and record a wide range of operations and activities, including manufacturing, product testing, distribution, storage, and logistics, so it can:

  • Produce accurate and consistent data
  • Create a tamper-proof, transparent, traceable, and indelible electronic data trail
  • Archiving the electronic data recordings in a safe, secure, and long-lasting manner

Validation is a vital tool to assure the quality of computer system performance. CSV improves system reliability, leading in fewer errors and a reduced risk of process and data integrity. CSV also lowers long-term system and project expenses by lowering maintenance and rework costs.

computer system validation

Where is CSV Used?

CSV is applied to GxP computerized system applications utilized at every step in the research, clinical testing, production, distribution, and storage processes. Here are some examples:

  • Laboratory information management system
  • Laboratory Instrument System
  • Clinical Trial Monitoring System
  • Building Management systems
  • Spreadsheets
  • Chromatography Data System

Need of CSV

The pharmaceutical and medical device sectors are regulated. That is what happens inside the factory walls is governed by the law. In the 90s the regulatory authorities are decided to replace paper records and handwritten signatures with electronic records.

software validation

CSV is a method of creating permanent electronic data that enables us to treat regulated data and electronic signature captured in drug discovery, drug trials, manufacturing, distribution, and storage as the legal records of paper and handwritten signatures with the same level of confidence in their accuracy, reliability and data integrity.

Demand for CSV Professionals

As manufacturing processes become increasingly automated, the demand for CSV Professionals is always high. One of the biggest misunderstandings about the CSV role is that you need to be able to code. isn’t always the case. However, in some areas where the job description overlaps with automation engineering, the ability to code is occasionally required. You’ll also need a thorough understanding of the computer process that you will be validating.

If you have the relevant skills or experience in pharmaceutical or medical device manufacturing. This is the best time to apply for CSV roles. If you are looking for any recruitment service in CSV Jobs, Get in touch with Venus Consultancy. We are the leading recruitment agency in Canada.


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