When does a software tool require validation?

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If a software tool is used for any process that affects product or quality systems in a regulated sector like life sciences – pharmaceuticals, medical technology or healthcare – then its use will need to be validated to meet the relevant regulations. It’s important to note that it is not the software tool itself that needs to be validated, but rather its use within the context of the process.

For clarity, by software tool, we’re referring to tools used to develop and monitor the use of products. This might include Excel documents,  statistical packages, compilers, customer management software, electronic inventory management tools, electronic laboratory management system, and so on.

We’re not referring here to software that is actually part of  a medical device or a drug-device combination, or software used for business processes such as bookkeeping.

Here are a few examples of instances where validation would be required:

  • An automatic continuous integration process
  • A document management process
  • Laboratory quality control tests

Don’t be deterred by the need for validation

Don’t let the need for validation put you off from using computerised systems, because the benefits far outweigh the effort involved.

It’s worth bearing in mind that paper-based quality processes will still require some elements of validation. For example the process description itself must be given following a formal and approved procedure, and each record generated by the process must be approved by human beings. The efforts involved in controlling the process will be significant and the process itself will be far less efficient.

Computerised systems can significantly reduce the ongoing efforts involved and become a key element in sustaining and improving the effectiveness of your team.