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Paper-based or electronic records?

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Guest user Created:   Jun 27, 2019 Last commented:   Jun 27, 2019

Paper-based or electronic records?

What is the best practice with regards to records management? Do you suggest paper-based (physical) or electronic records? For now, I only have electronic records. Do you suggest we create physical records in addition?
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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 Jun 27, 2019

Answer:

The best practice is the one that is best for you. The purpose of the records is that they confirm that some work has been done. How these records will be organized depends solely on your business and core process:

a) what kind of jobs do you have (whether it's manual work in a workshop where there is no computer or tablet, or it's all automated and directly involving a computer/server);
b) are electronic forms always available to all employees;
c) whether the records are easily retrieved in case they need to prove compliance;
d) whether the records are protected from manipulation (subsequent data modification) or loss (whether there is a corresponding back-up).

In any case, it is recommended not to duplicate records where it is not needed (eg legal obligation).

For more about document management system, ple ase read article:
Common mistakes with ISO 13485:2016 documentation control and how to avoid them
https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/

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Jun 27, 2019

Jun 27, 2019