Software verification and validation AS9100

#1
Hi,

we are currently reviewing the Computerized System Validation requirements for a planned collaboration with another company, who, among others, produce parts for use in aviation applications (as a supplier for an aircraft manufacturer). While we are familiar with CSV in medical devices, we are not sure how to interpret the requirements from the AS9001, in particular 8.5.1.1 Control of Equipment, Tools, and Software Programs: Equipment, tools, and software programs used to automate, control, monitor, or measure production processes shall be validated prior to final release.

Does this mean we need to validate all software assets that might have an influence on quality of the final parts? How does this work in practice in aviation, do we need to have a similar approach here as we have in CSV for medical devices, and does this get audited? Or do are we viewing this topic based on our medical device requirements, and in aviation this does not need to be controlled as closely, especially for suppliers not directly involved in the manufacturing of aircrafts?

I did find very little concrete information regarding this topic online, I would greatly appreciate any input or guidance you might have to steer me in the right direction. Our partner so far uses very little technology in their production environment and have a different approach to quality control from us, therefore they also cannot give us much information.

Thanks!
Marcus
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 6
T Class II Software Device 510k V&V (Verification and Validation) Criteria and Results 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Medical Device Software Verification & Validation for Client Specific Configurations Design and Development of Products and Processes 2
S Medical Device Software Verification and Validation Results - What is necessary? Software Quality Assurance 4
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 2
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 7
S IEC 62304 - Software verification cost IEC 62304 - Medical Device Software Life Cycle Processes 3
J IATF 16949 7.1.5.2.1 software verification IATF 16949 - Automotive Quality Systems Standard 1
D Software Revisioning and Verification IATF 16949 - Automotive Quality Systems Standard 7
L Documentation of Medical Device Software Verification activities Other US Medical Device Regulations 7
S Verification software - EN 62304 applicable? IEC 62304 - Medical Device Software Life Cycle Processes 18
W ISO9001 Clause 7.4.3 - Verification of Purchased Product - Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Chennaiite Is Design Verification Software required to be Calibrated IATF 16949 - Automotive Quality Systems Standard 7
J Medical Device Software Verification Requirements Design and Development of Products and Processes 7
Q ISO 62304 (Medical Device Software Development) Verification Requirements IEC 62304 - Medical Device Software Life Cycle Processes 1
S Checklist for RA and QA Review of DVT (design verification test) for Software Other US Medical Device Regulations 2
B Ford - Verification of Software (SPC) Statistical Analysis Tools, Techniques and SPC 2
A Review and Verification for Maintaining Software Software Quality Assurance 10
J How & how often to perform verification of Test Software of Automatic Test Equipment? General Measurement Device and Calibration Topics 3
F 4.11.1 Test Software Verification ? QS-9000 - American Automotive Manufacturers Standard 1
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
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 12
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
Y RT-qPCR Software result EU Medical Device Regulations 0
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
F WANTED Senior Software engineer Career and Occupation Discussions 2
P Blood establishment computer software EU classification EU Medical Device Regulations 0
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
D Integrated Management System Software Quality Manager and Management Related Issues 2
B Sampling strategies/techniques for software QA Software Quality Assurance 2
K MDCG-2020-3 (about the software of UI) EU Medical Device Regulations 3
D PFMEA Software search IATF 16949 - Automotive Quality Systems Standard 7
C MDR software classification EU Medical Device Regulations 12
H Class II a vs "software safety class A" IEC 62304 - Medical Device Software Life Cycle Processes 3
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 5
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Aymaneh UDI-PI Software CE Marking (Conformité Européene) / CB Scheme 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
Y Software updates considered servicing (7.5.4) ISO 13485:2016 - Medical Device Quality Management Systems 4
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3

Similar threads

Top Bottom