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How to implement Computer System Validation (chapter 7.5.6) without excessive effort and costs?

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Guest user Created:   Oct 07, 2020 Last commented:   Oct 08, 2020

How to implement Computer System Validation (chapter 7.5.6) without excessive effort and costs?

How to implement Computer System Validation (chapter 7.5.6) without excessive effort and costs in a small company?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Oct 08, 2020

Requirement 7.5.6 consider the validation of processes for production and service provision. Section 4.1.6 considers software validation. In small companies, always is a question of how to implement this requirement. You have to understand that you need to validate only software that can have an impact on the or quality of your management system or on the safety of the medical device. This means that you do not need to validate word processor or spreadsheet software. But if you have software for managing your warehouse and delivery process, that you need to be sure that in the case of a software update, your warehouse quantity of goods, lot numbers, invoice numbers, and delivery notes have not changed.

If you have any software in the production, software that runs the machine, that software also needs to be validated. 

However, these validations are not software type validations. With this validation, you need to prove that the software updates did not disrupt your database. 

For example, for the number of the invoices and delivery notes, the easiest way is to check the is numbering in the expected sequence, for warehouse, does the quantity on the shelves corresponds to the number defined in the program. 

You can see how the record for software validation looks like in our ISO 13485:2016 Documentation toolkit here:

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Oct 07, 2020

Oct 08, 2020