Hello all
I'm wondering to what extent I can rely on the existing types and sources of controlled information for my new 13485 system, rather than having to impose document/record templates across 4 departments which will follow the system?
For example, Is it acceptable to say that the information parameters defined on 'form A' must be maintained by all departments. Ideally they would use 'form A' and keep it as a record either electronically or in paper format. If one department translates 'form A' data fields onto a departmental system they are using, this meets the requirements. However, if they fail to record all of the information defined on 'form A', this is a non-conformity.
Essentially I want to define what information must be documented, but allow flexibility in how this is documented for each department because of their existing system differences.
Thoughts appreciated..
James
I'm wondering to what extent I can rely on the existing types and sources of controlled information for my new 13485 system, rather than having to impose document/record templates across 4 departments which will follow the system?
For example, Is it acceptable to say that the information parameters defined on 'form A' must be maintained by all departments. Ideally they would use 'form A' and keep it as a record either electronically or in paper format. If one department translates 'form A' data fields onto a departmental system they are using, this meets the requirements. However, if they fail to record all of the information defined on 'form A', this is a non-conformity.
Essentially I want to define what information must be documented, but allow flexibility in how this is documented for each department because of their existing system differences.
Thoughts appreciated..
James