How to start with computer system validation?

Life sciences enterprises in for example the pharmaceutical, biotechnology and medical devices industry must validate computer systems that have an impact on the product and thus the patient safety. A computer system consists of more than just software and hardware; it includes procedures, processes, equipment, training and much more. In addition, ensuring the data integrity and traceability of information and product quality is a requirement as well.

As they are increasingly integrated in many of the key business processes, computer systems help to reduce or eliminate risks inherent to manual processes traditionally carried out by qualified personnel. However, it should be noted that computer systems do not completely replace the human factor. They simply raise the level within a process, meaning the risk of human error is still present. That’s because equipment and systems rely on programmers telling the systems what to do, meaning a human error in this stage can result in an error in the system.

All of these definitions include the elements compliance, providing evidence and the confirmation that ‘it’ has fulfilled the expectations. However, as mentioned before, a computer system doesn’t just consist of hardware and software.

  • According to the Food and Drug Administration (FDA), the definition of validation is:
    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.
  • According to the European Union, the definition is:
    Action of proving, in accordance with the principles of Good Manufacturing Practice, that any procedure, process, equipment, material, activity or system leads to the expected results…
  • The Food and Drug Administration has the following to say about software validation:
    Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.
  • And according to the World Health Organisation, it’s:
    Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.

These definitions include the elements compliance, providing evidence and the confirmation that ‘it’ has fulfilled the expectations. However, as mentioned before, a computer system entails more than only hardware and software. The definition of a computerized system is according to the:

  • Food and Drug Administration:
    A computerized system includes hardware, software, peripheral devices, personnel, and documentation; e.g., manuals and Standard Operating Procedures. See: computer, computer system.
  • European Union:
    A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control.
  • The International Society for Pharmaceutical Engineering sees it as:
    A broad range of systems including, but not limited to, automated manufacturing equipment, automated laboratory equipment, process control and process analytical, manufacturing execution, laboratory information management, manufacturing resource planning, clinical trials data management, vigilance and document management systems. The computerized system consists of the hardware, software, and network components, together with the controlled functions and associated documentation.
  • And according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use it’s:
    A process or operation integrated with a computer system.

The computer system is the combination of hardware and software in conjunction with the process they serve and the operating environment.

A last note: the increasing use of new technologies, such as artificial intelligence (AI), interfaces with mobile devices and cloud-based systems, which is a challenge for validation. The FDA wants to encourage companies to use new technologies. Therefore, a new guidance will be published which puts more emphasis on assurance when it comes to validating a computer system.

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