Software SOP - Use and maintenance of an ERP system

#1
Hello,
Does anyone have an SOP or Policy template for use and maintenance of an ERP system? It would be a general procedure/policy that points to specific modules WIs.
Thank you in advance!
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#5
Doubt this will help much for what you're directly looking for...but since no one else has offered...

All but one of the ERP systems I've seen were "closed systems" where maintenance was performed by an outside party, and use manuals were provided either by that same party, or by the installer/customizer.

Take SAP for example...a duly authorized SAP subcontractor would perform all maintenance since the user cannot.
It is also MUCH easier for someone with "edit authority" for function to perform data checks for widows, orphans or potential corruption.

All of that said to describe why a "Maintenance manual" would not be at the user site...it would be at the contractor's site.
A "user manual" such as one might be would come from the customizer, so it could contain any custom functionality.

HTH a little...
 
Thread starter Similar threads Forum Replies Date
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 8
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
I Software Design SOP to ISO 62304 (Software life cycle for Medical Device) IEC 62304 - Medical Device Software Life Cycle Processes 3
T Incorporating the Use of a Specific Software in an SOP - Validation of QA Software Qualification and Validation (including 21 CFR Part 11) 4
B ISO 14971 Applied to Software ISO 14971 - Medical Device Risk Management 2
N ERP Software Implementation Manufacturing and Related Processes 3
C NCR (Nonconformance System) Software Nonconformance and Corrective Action 6
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Risk Assessment Checklist for Non product Software IEC 62304 - Medical Device Software Life Cycle Processes 1
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
J Designing new gauge tracking software IATF 16949 - Automotive Quality Systems Standard 4
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 1
B Notified Bodies for Software (MDR) EU Medical Device Regulations 1
C MDR - Question around software accesories EU Medical Device Regulations 2
S Software for Supplier Charge back and internal PPM General Information Resources 2
G Assignable cause/corrective action list for SPC Software Statistical Analysis Tools, Techniques and SPC 3
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 3
S Recommendation for user friendly Gaga R&R and Cpk software Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
M HR (Human Resources) based software recommendations Human Factors and Ergonomics in Engineering 2
V Gage Management and Gage R&R Software General Measurement Device and Calibration Topics 1
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
Marc Security in Health Industry Software - February 2020 IEC 27001 - Information Security Management Systems (ISMS) 0
D Software validation in Medical Equipment Other Medical Device and Orthopedic Related Topics 20
C Experience with Agile PLM (Product Lifecycle Management Software) software from Oracle? Document Control Systems, Procedures, Forms and Templates 3
JoCam Software Translation under MDR requirements EU Medical Device Regulations 5
W Air Quality Measurement Hardware and Software General Measurement Device and Calibration Topics 11
Q Is that any difficulty to do software DFMEA and PFMEA in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 5
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 7
C QMS Document Management Software Recommendations Quality Assurance and Compliance Software Tools and Solutions 15
Z Software Library - could it be a medical device? ISO 13485:2016 - Medical Device Quality Management Systems 5
B HIGH QA Software - Auto ballooning software Quality Assurance and Compliance Software Tools and Solutions 2
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
I Custom software services to be used by medical software ISO 13485:2016 - Medical Device Quality Management Systems 1
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
S Best software for customer support/complaints? Customer Complaints 0
D Reduction of software class based on multiple external risk controls IEC 62304 - Medical Device Software Life Cycle Processes 5
M Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 1
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
G Strategy for IEC62304 implementation half way into the software development process IEC 62304 - Medical Device Software Life Cycle Processes 9
F Software development plan for SW update IEC 62304 - Medical Device Software Life Cycle Processes 2
D Requirements for the dimensions / color of medical device labels - Software as a Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 2
T Electronic ECO/ECR Process - Software recommendations Document Control Systems, Procedures, Forms and Templates 3
B We need a QMS: file-based templates or software Other Medical Device Related Standards 23
C Looking for simple Software Validation IQ templates. Qualification and Validation (including 21 CFR Part 11) 4
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
H QMS Software Recommendation (US based, Hemp) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Software as an accessory to a Class I medical device EU Medical Device Regulations 4
D Monitoring and measuring resources - Example of how section ISO 9001 7.1.5 would apply to a manufacture of software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Software Development Company - Who would own the whole process and the certification afterwards? ISO 14001:2015 Specific Discussions 1
Similar threads


















































Top Bottom