Software for design control

zippo

Registered
#1
Dear all,

I am looking for inspiration.
What software are you using for system engineering and design control?

Cloud preferred.

Thank you in advance.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
That's a really broad question. What, specifically, are you hoping to accomplish with the software (issue tracking, document control, requirements tracing, ...)?
 

yodon

Staff member
Super Moderator
#4
There have been quite a few discussions of "eQMS" systems on this site. I'm sure a search will turn up plenty. Just off the top of my head, I can think of ETQ, QCBD, Q-Pulse, MasterControl, Arena, and BPA. (Please do not take that as an endorsement of any of those; just tossing out what I've been exposed to).

I don't know of any such system that incorporate a code repository (and presumably change management). To that end, I know of systems such as SVN, Github, and Bitbucket that seem to be popular.

I think there are some that do requirements tracing but that's kind of a niche tool. (DOORS is very powerful but the overhead involved is challenging for many.)

I don't know of any that support risk analysis activities. I think many use Excel spreadsheets for the bulk of the work (again, a search on this site should turn up some). The eQMS systems will, of course, handle any document control aspect.

Bear in mind that an investment in such tools is not a 'silver bullet.' As you assess tools, be sure to know what your requirements / needs are and how the tools fit. There will likely be a more-than-nominal investment on your part for setup and maintenance. Understand what that overhead is before jumping in. I've seen a lot of good tools maligned because they weren't appropriate, weren't set up properly, and/or weren't being used properly.
 
Thread starter Similar threads Forum Replies Date
J Design Control & Rapid Prototyping - Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
P Software requirement and design specifications - Medical device contains both hardware and software IEC 62304 - Medical Device Software Life Cycle Processes 2
JoshuaFroud Design and Development of Software under 13485:2016 or 62304? ISO 13485:2016 - Medical Device Quality Management Systems 6
L Software Medical Device - 7.3.8 - Design and Development Transfer ISO 13485:2016 - Medical Device Quality Management Systems 4
L Design software for a spectrophotometer for 21 CFR Part 11 compliance Qualification and Validation (including 21 CFR Part 11) 1
A Are Software Requirements Specifications part of Design Input? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R Medical Device Software Segregation and Detailed Design IEC 62304 - Medical Device Software Life Cycle Processes 10
M Design and Development Outputs for Software Development (7.3.3) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
H Involving into Electronic and Software Design Issues Quality Manager and Management Related Issues 3
M Software Design Specification - How in depth should this be? US Food and Drug Administration (FDA) 5
R Cloud Computing Requirements for Design History Files for Software Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
V Any experience/feedback on statistical software tools...minitab -design expert -JMP Using Minitab Software 4
Chennaiite Is Design Verification Software required to be Calibrated IATF 16949 - Automotive Quality Systems Standard 7
sagai What if ... Source code part of the SDS (Software Design Specification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
H Paper based DHF (Design History File) updates for Software Updates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Checklist for RA and QA Review of DVT (design verification test) for Software Other US Medical Device Regulations 2
S Special 510k Operating System for Data Management Software Design Documents 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
K Medical Device Software - Design Outputs? ISO 90003 and ISO 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
A Design Review OR Design Change - Software development company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
N Software Requirements specification vs. Design Specification - Differences Qualification and Validation (including 21 CFR Part 11) 10
P Software to help meet ISO & AS9100 Design & Development Rqmts Design and Development of Products and Processes 2
M ISO 9001 Requirements for associated service - Design and develop software Design and Development of Products and Processes 7
ScottK Do you use Collaborative Software? - I'm looking to streamline design process After Work and Weekend Discussion Topics 11
J Help! Need sample procedures for Product & Software Design and Development Design and Development of Products and Processes 4
A Mechanical Design Procedure - Infusion pump incorporating software - Medical Device Design and Development of Products and Processes 1
M Seeking sampling plan software and military standard design software Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Design for Manufacturability (DFM) Software - Seeking advice Design and Development of Products and Processes 2
Marc Excluding Design from Scope - Software Company Design and Development of Products and Processes 0
M Initial Importer/Distributor and Software Validation IEC 62304 - Medical Device Software Life Cycle Processes 0
F Configurator for a power unit - Software or other solution? Manufacturing and Related Processes 0
D Test Management Software Software Quality Assurance 1
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Tracking software versions used with instruments ISO 13485:2016 - Medical Device Quality Management Systems 0
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
S Do you follow your QMS for non-device software features? Medical Information Technology, Medical Software and Health Informatics 4
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 2
J EU equivalent to Clinical Decision Support Software EU Medical Device Regulations 3
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13
S Recommended software to send Quality scorecards to suppliers (external providers) Supplier Quality Assurance and other Supplier Issues 3
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
BeaBea QMS/ Training Management Software Service Industry Specific Topics 4
shimonv Working with a software developer who is not setup for IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
R Debug mode in software/device validation IEC 62304 - Medical Device Software Life Cycle Processes 2
Q Gage calibration / tracking software General Measurement Device and Calibration Topics 5
M Software verification and validation AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Y RT-qPCR Software result EU Medical Device Regulations 0

Similar threads

Top Bottom