Software PPAP? New or changed software

GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Howard Atkins

Howard Atkins

Forum Administrator
Staff member
Admin
#2
#2
Re: Software PPAP?

Mike48 said:

:bigwave:

Does new / changed software require PPAP?
Click to expand...
Have you submitted PPAP before for software?
There is no reference in the PPAP booklet to software.
As usual if in doubt ask the customer.
 
A

A. Stuart Dyer

#4
#4
I believe that PPAP requires the use of their documents or documents that contain the same information. As long as there is no change in the content of the PPAP/APQP I don't see any reason why a change in software would affect the receiving plant.

Now, if you are changing software you might want to consider it a continuous improvement project and take credit where credit is due!
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
I Any recommendations on software for managing the APQP, PPAP, PFMEA, Control Plan etc? Quality Assurance and Compliance Software Tools and Solutions 2
Q Need guidance new APQP and PPAP Process Improvement Software Idea Quality Assurance and Compliance Software Tools and Solutions 1
K Can anyone recommend a PPAP software package? Quality Assurance and Compliance Software Tools and Solutions 11
T PPAP Software Suggestions APQP and PPAP 11
L PPAP Software Recommendation Wanted Quality Assurance and Compliance Software Tools and Solutions 19
M Software to Handle All "Quality" Processes? APQP, Control Plan, FMEA, MSA, PPAP, etc. Quality Assurance and Compliance Software Tools and Solutions 1
S Recommended PPAP Training in the Toronto area or a software solution Training - Internal, External, Online and Distance Learning 3
Q Software solution to manage APQP and PPAP Quality Assurance and Compliance Software Tools and Solutions 3
M Looking for PPAP (APQP) type software for our company APQP and PPAP 5
D Test Management Software Software Quality Assurance 1
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 3
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 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
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
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 3
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
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 6
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
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 7
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
L Micro-Vu InSpec Software Program Qualification and Validation (including 21 CFR Part 11) 6
A For software change - New Channel of interoperability CE Marking (Conformité Européene) / CB Scheme 5
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom