QMS software validation - Documentation

S

snoopy2017

#1
Hi everyone,

Where in the QMS do software validation plans and reports exist? Should they be part of a DMR? To my knowledge, something like ERP validation is not device specific, so should its validation plans and report be integrated into the general QMS? Thanks. I look forward to your response. :)
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
There is product software (software in a device or software that is a device) and non-product software (that which is used in the execution of the QMS).

Product software (which is clearly extended down to low-level firmware!) does, indeed, have validation (and verification) plans and reports which are part of the DHF but wouldn't be part of the DMR.

Non-product software (your ERP example), would also have validation plans and reports but these are just kept as quality documents / records and, since not part of the product, would be outside of the DMR or DHF.

Does that help?
 
#3
Hi everyone,
Regarding the above discussion. our company deals with distribution of medicaL devices. I would like to know in which way , computer validation principle of ISO 13485 is applicable to our company..... we are in the process of compiling our quality manual and your input will be appreciated. Thank you
 

yodon

Staff member
Super Moderator
#4
If you use software to support the distribution effort (consignee information, etc.) then I expect you would need to validate that software.

I generally recommend taking inventory of ALL software applications used and then determining if any are used in execution of the QMS. If not, validation isn't required. If so, then it probably is. Documenting the decision process is helpful, IMO.
 
#6
Building upon @yodon's answer, also note that the process for validating product vs. non-product software is different: For non-product software it's software validation based on the ISO 13485, for product software it boils down to SOUP (heh) verification / validation as per IEC 62304 :)
 
Thread starter Similar threads Forum Replies Date
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
A Process Validation of QMS Software ISO 13485: 2016 Cl. 4.1.6 ISO 13485:2016 - Medical Device Quality Management Systems 26
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
C QMS Document Management Software Recommendations Quality Assurance and Compliance Software Tools and Solutions 14
B We need a QMS: file-based templates or software Other Medical Device Related Standards 23
H QMS Software Recommendation (US based, Hemp) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Benefits of electronic QMS software Software Quality Assurance 5
T Risk analysis of QMS software - Validating software we use for QMS ISO 13485:2016 - Medical Device Quality Management Systems 5
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
J Choosing QMS Software for Aerospace Company Quality Assurance and Compliance Software Tools and Solutions 5
G Looking to move to an electronic QMS software Software Quality Assurance 11
J Does anyone here use ISOXpress/IMSXpress QMS software? Software Quality Assurance 11
M Switching (Migrating) to a new QMS Software Package Document Control Systems, Procedures, Forms and Templates 14
QIE QMS and PLM software recommendations Medical Information Technology, Medical Software and Health Informatics 6
P QMS software recommendations for a small ISO 13485 company Quality Manager and Management Related Issues 5
A ISO 13485:2016 - Validate our use of software that impacts on the QMS ISO 13485:2016 - Medical Device Quality Management Systems 8
Q QMS Software for Startup Medical Device Company Other Medical Device and Orthopedic Related Topics 7
D Anyone using a cloud based QMS software? Document Control Systems, Procedures, Forms and Templates 12
I How much does an eQMS (Electronic/Software QMS) cost? Quality Assurance and Compliance Software Tools and Solutions 1
A Software Suggestions for Engineering Change/QMS Design and Development of Products and Processes 2
W QMS and/or ERP software choices for both US and China Quality Assurance and Compliance Software Tools and Solutions 2
Q Finding the best QMS Software Quality Assurance and Compliance Software Tools and Solutions 4
K QMS Software Recommendations for an Analytical Laboratory General Measurement Device and Calibration Topics 2
G QMS Quality Plan Documents Software Document Control Systems, Procedures, Forms and Templates 4
D QMS Software Recommendations for a Small Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
J General QMS questions in regard to Medical Software ISO 13485:2016 - Medical Device Quality Management Systems 8
Marc What QMS and Regulatory Compliance Software are you using? Quality Assurance and Compliance Software Tools and Solutions 7
A Software Tools for managing a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Best Custom Software (To Track QMS & Processes) Provider Quality Assurance and Compliance Software Tools and Solutions 9
D FDA Compliant QMS Software Recommendation for Small Company Quality Assurance and Compliance Software Tools and Solutions 3
T Quality Compliance Software to meet ISO 13485 QMS and 21 CFR 820 Requirements Quality Assurance and Compliance Software Tools and Solutions 3
E Cheap, Cheerful Software QMS System Quality Assurance and Compliance Software Tools and Solutions 7
J0anne QPulse 5 - QMS - Software Opinion and help Quality Assurance and Compliance Software Tools and Solutions 11
G Various ?QMS? packages on the market - Which software package? Quality Assurance and Compliance Software Tools and Solutions 35
B Using Job Shop ERP Software for a QMS Quality Assurance and Compliance Software Tools and Solutions 2
J QMS Software Checklist and Comparisons Matrix Quality Assurance and Compliance Software Tools and Solutions 2
K What are some of the best QMS Software Packages available? Quality Tools, Improvement and Analysis 5
K QMS Software - EtQ vs Trackwise Quality Assurance and Compliance Software Tools and Solutions 5
M MRP/QMS Software Package to replace our current Paper QMS - Help Quality Assurance and Compliance Software Tools and Solutions 4
A QMS and Computerized Software Compliance with Standards US Food and Drug Administration (FDA) 6
D Medical Devices Company QMS Software - Recommendation for an off the shelf software ISO 13485:2016 - Medical Device Quality Management Systems 13
L Mac OS X Compatible CFR Part 11 Complaint QMS Software Other US Medical Device Regulations 5
somashekar Software for QMS administration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Should Purchased Software for both SPC and Gage R&R be documented in the QMS? Quality Assurance and Compliance Software Tools and Solutions 2
Sidney Vianna AS9115 - Aerospace QMS Standard for Deliverable Software AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
V What qualification is needed for working as QMS Engineer in a software company? Training - Internal, External, Online and Distance Learning 6
W QMS Software for Healthcare providers Hospitals, Clinics & other Health Care Providers 6

Similar threads

Top Bottom