Computer Systems Validation (CSV)

CSV short for Computer Systems Validation is used in various businesses, we offer services specifically for Medical and Automotive use.

CSV is the process of validation to meet the FDA's definition: The FDA defines process validation as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes." Therefore the objective of validation, is to produce documented evidence that parts of the facility will work correctly every time, when brought into use. The goal is also to make sure that quality is built in to the system at every step; and not just a factor at the 'output' end of the process chain.

FDA: Examples of Computer Systems

  • Automatic manufacturing apparatus
  • Control systems
  • Laboratory data capture devices
  • Automated laboratory equipment
  • Manufacturing execution systems
  • Laboratory, clinical or manufacturing database systems


Basic Requirements

Computer System Validation requires, first, that you obtain/design a process that conforms to requirements; and then that you run tests demonstrating that it is consistent. Both steps can be performed with the aid of the right statistical tools. To summarize the requirements are:

  1. Development of a validation plan
  2. Utilization of Standard Operating Procedures (SOPs)
  3. Documented Training on SOPs
  4. Development of detailed specifications
  5. Development of a test plan and/or test scripts

Both the FDA and ISO 13485:2003 require computer system validation. Many regulated companies, however, still use unvalidated computer systems.

Failure of CSV: Common Reasons

Without planning and preparation, Computer System Validation can encounter problems, eventually leading to failure of the process. Problems include:

  1. Inadequate documentation of plans
  2. Inadequate definition of what constitutes the computer system
  3. Inadequate definition of expected results
  4. Inadequate specification of software
  5. Software that does not meet its specifications
  6. Unavailable source code for software

If you're looking for detailed recommendations for efficient execution of validation projects, as well as information on user validation as required by 21 CFR Part 11

Now all of this may seem too much to some, or need clarification which is why we offer our services and help, therefore please feel free to contact us.