21 CFR Part 11 Compliance: System Validation

Last revised: 

What's a Computer System and How Do I Validate It?
A computer system consists of hardware, software, people, and processes that interact with one another towards the same end goal. Each part of the system must function properly by itself, and where there is overlap, must properly interface with the other parts of the system without introducing error to other parts. Computer system validation is basically due diligence – making sure that a system works correctly for its intended use in the context of your research.

Computer system validation addresses each of the parts independently, and then together, to ensure that they fit together and perform in the way that you need them to in order to meet your intended objective.

Benefits of Validation

  • Increased usability and reliability over time
  • Reduced regulatory liability
  • Reduced cost of implementation
  • Supportable

A system validation plan provides a roadmap for project personnel. It defines the scope of work, user needs, expected work products (i.e., documentation, hardware, and software), tasks to be performed, verification activities, timelines and milestones, resources and budget, and roles and responsibilities.

Considerations when putting together your plan:

  • Tasks and deliverables depend on factors such as project complexity, size, and resources – the regulations are flexible in this respect.
  • Simplify validation of large or complex projects. Break them into smaller logical units and validate each grouping separately, first.
  • Commercial software, whether being used as a stand-alone, or integrated into a larger system, must be validated for your particular use.
  • An existing system that has not been validated, but that creates electronic records, must be validated retroactively.