eQMS/ERP System Admin Work Instructions - Where do they fit?

[danirenee]

Hi! My company is in the process of implementing an eQMS/ERP system and cranking out the work instructions for how the systems are used. I am trying to categorize the work instructions relevant to our QMS processes (ISO 13485) as opposed to those that are considered "business documents."

I would appreciate any insight you may have regarding the categorization of WIs specific to a system administrator, such as creating/modifying/maintaining sites, domains, users, roles, permissions, etc. within the system. Would you categorize these activities as business-related or QMS documents? If QMS, under what aspect would they best fit?
For example, our QMS documents follow a hierarchy starting at a policy level, where the policies are "buckets" structured after 13485. So, would you bucket these system admin WIs under "infrastructure", "resource management", or would you place them under their own policy bucket?
Thanks in advance for your thoughts!

 

[Stijloor]

A Quick Bump!

Can someone help with this question?

Thank you very much!

 

[Ninja]

Not so sure there's a requirement about this you'll find, so it's all preference...

My preference would be to start a subseries under "Administrative" and put tech support in one bucket (say AD8-XX) and Software admin in another bucket (say AD9-XX)...but that's just me.

FWIW, I would only capture the routine "you do it this way or it goes wrong" stuff, not the general troubleshooting.

Computer and software troubleshooting is not a play-by-the-numbers kind of thing...a call to a computer tech support line can show you that...the Tier I operators are reading from a checklist, and it never works.
Until you reach Tier II that can think for itself, or Tier III where people actually have expertise it is typical for all options to fail. Tier II and Tier III don't have checklists, they have understanding instead.

I would hate to see a WI for "solving a connectivity issue" or "creating a new sales report"...but again, that's just me.

HTH,

 

[danirenee]

Thanks so much for your input! I agree, I want to place them under their own bucket for administering the system - not under a QMS bucket.

 

[Ninja]

FWIW...why have two systems?

If revision control is needed, you already have a system for that...your QMS.
Not because you HAVE TO, but because it's efficient.

 

[KARENMARY]

Hi! My company is in the process of implementing an eQMS/ERP system and cranking out the work instructions for how the systems are used. I am trying to categorize the work instructions relevant to our QMS processes (ISO 13485) as opposed to those that are considered "business documents."

I would appreciate any insight you may have regarding the categorization of WIs specific to a system administrator, such as creating/modifying/maintaining sites, domains, users, roles, permissions, etc. within the system. Would you categorize these activities as business-related or QMS documents? If QMS, under what aspect would they best fit?
For example, our QMS documents follow a hierarchy starting at a policy level, where the policies are "buckets" structured after 13485. So, would you bucket these system admin WIs under "infrastructure", "resource management", or would you place them under their own policy bucket?
Thanks in advance for your thoughts!

Hi , did you validate your ERP System and if so how did you go about if?

Thanks