Paper-based or electronic records?
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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