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

D

danirenee

#1
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!
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#3
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,
 
D

danirenee

#4
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. :)

:thanks:
 

Ninja

Looking for Reality
Trusted Information Resource
#5
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.
 
#6
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
 
Thread starter Similar threads Forum Replies Date
D EQMS - When the internet or system might not be available ISO 13485:2016 - Medical Device Quality Management Systems 7
F Grand Avenue Software, Q-Pulse or Qualio - which for a full eQMS? Medical Information Technology, Medical Software and Health Informatics 1
T EQMS for small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 11
K EQMS provider's pledge to COVID-19 Misc. Quality Assurance and Business Systems Related Topics 1
S Validation of eQMS - Cloud based out of the box solution Other Medical Device Related Standards 18
S EQMS solution (Greenlight Guru and Q-Pulse currently being explored) Medical Information Technology, Medical Software and Health Informatics 8
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
I How much does an eQMS (Electronic/Software QMS) cost? Quality Assurance and Compliance Software Tools and Solutions 1
J Implementing a TrackWise eQMS System Quality Assurance and Compliance Software Tools and Solutions 3
N ERP Software Implementation Manufacturing and Related Processes 3
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 8
Q Software SOP - Use and maintenance of an ERP system Software Quality Assurance 6
qualprod What is the Normal Flow in an ERP for Manufacturing? Manufacturing and Related Processes 0
K Identification and Traceability with an ERP system - Barcode Labels? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
W ERP Audit Trail audit by FDA? Regular audit trail report template? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
L Off the Shelf Software VISUAL ERP system ISO 13485:2016 - Medical Device Quality Management Systems 1
S Where to keep Enterprise Resource Planning software (ERP) Validation Records ISO 13485:2016 - Medical Device Quality Management Systems 1
J PMA Device - Lot # change in New ERP Software - What are the FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Small Business ERP System - Recommendations wanted Manufacturing and Related Processes 5
S ERP Software and Quality Department Procedures Integration Misc. Quality Assurance and Business Systems Related Topics 4
Joe Cruse ERP Systems and Your Pain Coffee Break and Water Cooler Discussions 5
pbojsen ERP Data Control Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
G Paper Based Manufacturing with an Unvalidated ERP ISO 13485:2016 - Medical Device Quality Management Systems 3
A Lean and ERP software Lean in Manufacturing and Service Industries 0
W QMS and/or ERP software choices for both US and China Quality Assurance and Compliance Software Tools and Solutions 2
R Document Control when an ERP System Produces most Forms and other Paperwork Document Control Systems, Procedures, Forms and Templates 7
L Managing ITP with an ERP system Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
C New ERP System: Any Free Gantt Chart Software Recommendations Out There Quality Assurance and Compliance Software Tools and Solutions 2
A Which ERP system complies to medical device regulations? ISO 13485:2016 - Medical Device Quality Management Systems 4
D AS9100C 4.2.3 - Obsolete Electronic ERP Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R ISO 13485 - Security and Control of ERP System ISO 13485:2016 - Medical Device Quality Management Systems 1
K Validation of ERP/CRM Software Using Sandbox Qualification and Validation (including 21 CFR Part 11) 4
S Configuration Management System software that can also be linked to our ERP system AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
I ERP Software Validation - required or not? ISO 13485:2016 - Medical Device Quality Management Systems 3
I ERP acronym has double meaning in our company Internal Auditing 6
B Using Job Shop ERP Software for a QMS Quality Assurance and Compliance Software Tools and Solutions 2
Stijloor ERP (Enterprise Resource Planning) Manufacturing Software Recommendations Manufacturing and Related Processes 3
P ERP (Emergency Response Plan) for Small Air Operator EASA and JAA Aviation Standards and Requirements 7
T Document Control of ERP Report Format from Software Document Control Systems, Procedures, Forms and Templates 13
smryan M2M (Made2Manage ERP System) newby questions Document Control Systems, Procedures, Forms and Templates 2
I MRP/ERP for small CM/EMS Manufacturing and Related Processes 3
M Is ERP (Enterprise Resource Plannning) software like SAP in scope of AS9100 7.5.1.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C Setting Up Part Masters in ERP Systems - How are others doing it? Document Control Systems, Procedures, Forms and Templates 1
K Any one with experience on 'EPICOR' ERP System? Quality Assurance and Compliance Software Tools and Solutions 14
N Work Instructions for ERP (Enterprise Resource Planning) software Process Maps, Process Mapping and Turtle Diagrams 3
A Naming Convention for our ERP System Purchase Parts Document Control Systems, Procedures, Forms and Templates 4
W Validation of SAP for ERP - Inventory, shipping, and monitoring expiration dates Qualification and Validation (including 21 CFR Part 11) 18
I New ERP system - Need Doc. Numbers for ERP generated PO's, Packing Slips, etc? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Utilization of new ERP system - (IFS- Industrial and Financial Systems) Quality Assurance and Compliance Software Tools and Solutions 8
M NetSuite ERP and CRM features Validation for a medical device company ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom