Software change control process and defect tracking

racglobal

Involved In Discussions
#1
Hello

As a medical device manufacturer, our product is considered an electromedical device (i.e. IEC 60601 applies to us) , which is hardware containing software. My question concerns how software is controlled. The company has two teams, a software team that works independently at a different site. It does a lot of the coding. It has its own system of defect tracking, which is opaque to all of the rest of us. I have three questions:

1- Is the software defect tracking process supposed to be integrated into the QMS?
2-Everytime software needs to be upgrade, does it go through the same ECO process as we did for hardware design changes?
3-Is the software defect tracking akin to a complaint management system?

I look forward to your response. Thank you.
 
Elsmar Forum Sponsor

ECHO

Starting to get Involved
#2
1- Is the software defect tracking process supposed to be integrated into the QMS?
The tools you use for software development doesn't have to be same tools that you use for other quality activities, however, the software defect tracking process need to still be compliant to standards like 21 CFR part 11. Also don't forget to validate your tool.

2-Everytime software needs to be upgrade, does it go through the same ECO process as we did for hardware design changes?
Any change whether it is software or hardware should go through the same ECO process. There might be some tasks that you don't do, however, a justification is necessary. For example, I have seen a company get dinged for not writing a justification for not doing packaging testing for SW.

3-Is the software defect tracking akin to a complaint management system?
Take a look at Relationship between IEC 62304 problem resolution and ISO 13485

I have seen many software teams operate separately from the rest of the organization. As someone who has been on both sides of this, I don't think this is healthy for the company. Generally, the first step to bridge this gap should be writing a SOP for software development (IEC 62304) and putting a focus on how this SOP co-exists with the rest of the SOPs (ISO 13485, ISO 14971, etc)

I hope this helps.
 
Thread starter Similar threads Forum Replies Date
R SaMD - Software as a Medical Device - Software change control form ISO 13485:2016 - Medical Device Quality Management Systems 3
C Change Control Forms Post Software Validation Medical Information Technology, Medical Software and Health Informatics 2
K Change Control for Software System that Controls Aspects of GMP Quality Assurance and Compliance Software Tools and Solutions 5
E Help with ECR/DCR Document Change Control Software Validation Qualification and Validation (including 21 CFR Part 11) 6
L Engineering Change Control Software Systems - Recommendations? Document Control Systems, Procedures, Forms and Templates 2
K Software Device "Urgent" Releases? Software Change Control Process IEC 62304 - Medical Device Software Life Cycle Processes 9
J Software change control - How should I be controlling software changes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Enterprise change management control system software - Medical Devices Quality Assurance and Compliance Software Tools and Solutions 0
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
A Software Suggestions for Engineering Change/QMS Design and Development of Products and Processes 2
E Special 510(k) for software change Other US Medical Device Regulations 1
S Software Application for Management of Change (API 5.11) Other ISO and International Standards and European Regulations 3
T Class II Medical Device with Software - Change to Computer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Question surrounding Special 510(k) in regards to Software Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
R PMA (Parts Manufacturing Approval) Supplement - Labeling Software Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Management Of Change System or Software - Recommendations and Ideas wanted After Work and Weekend Discussion Topics 2
J Looking for a change template related to software change? Document Control Systems, Procedures, Forms and Templates 2
A Design Review OR Design Change - Software development company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
W When to change UCL and LCL - SPC Software Statistical Analysis Tools, Techniques and SPC 4
U Advice on Engineering Change Request (ECR) software Software Quality Assurance 4
Q Global change software where changing one document changes all documents Quality Assurance and Compliance Software Tools and Solutions 1
M Using M-1 Software for Quality - Manual Engineering Change Order Entry Quality Assurance and Compliance Software Tools and Solutions 1
D What constitutes a "significant change" in software AND what does not Software Quality Assurance 7
G PEDYN (Professional Engineering DYNamics) Change Mangement Software Quality Assurance and Compliance Software Tools and Solutions 4
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 2
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
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
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 8
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 6
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
Similar threads


















































Top Bottom