Software for linking Process Flow Diagram, Process FMEA and Control Plan

T

toonbaba

#1
i have been assigned the project of moving our companies current system (using MS Excel/Access) for process flow/pfmea/CP to APIS IQ.
Any help you can offer in terms of getting started with the software, training resources or any would be good.
In a nutshell: i aim to offer a live archive all under one uumbrella that links the PF/PFMEA/CP and that others can use. so any pointers you could give on how to get started for a months worth would be great. thanks again !
 
Elsmar Forum Sponsor

Helmut Jilling

Auditor / Consultant
#2
Powerway linked these together at some point. I was not a big fan of most of the Powerway system, but was told this module was actually pretty good....
 

IRONPOORER

Starting to get Involved
#3
i have been assigned the project of moving our companies current system (using MS Excel/Access) for process flow/pfmea/CP to APIS IQ.
Any help you can offer in terms of getting started with the software, training resources or any would be good.
In a nutshell: i aim to offer a live archive all under one uumbrella that links the PF/PFMEA/CP and that others can use. so any pointers you could give on how to get started for a months worth would be great. thanks again !
I have the same need- and have looked at several different different software packages but have not purchased any yet. I posted a querey for feedback from others on software they use and didn't get a lot of feedback.

Still looking for someone to say that they bought XYZ software and its the best cuz this, that and the other. Please post your experience with APIS for all of us lurking :)
 
T

toonbaba

#4
hi ironpoorer
I now have APIS IQ and i am in the process of implementing the new system. Being new to this all, I do not have previous experience using other softwares but till now it is good APIS. It is not particularly difficult to use, but it a lot of work which I beleive will be worth it at the end. It has a couple limitations here and there, but it is also quite flexible and customisable o in terms of linking all data.
 

IRONPOORER

Starting to get Involved
#6
We just had a Webex on this type software from IQS and have another scheduled with CEBOS next week. IQS seemed ideal, though I am sure the devil is in the details
 
T

tungstenh993

#8
Have you tried looking at VisualPPAP by IPI? We purchased there software to solve this exact problem, it helped us increase our visibility of our PPAP process without breaking the bank. If you're looking for a tool to maintain your PPAP process then i'd get yourself a free month trial as this is what we did. If you have any questions I'd be more than happy to answer via PM or here.

A
 
Thread starter Similar threads Forum Replies Date
V Internal Audit Software IATF 16949 - Automotive Quality Systems Standard 5
Watchcat New Draft Guidance on Content of Premarket Submissions for Software Device "Functions" Other US Medical Device Regulations 2
Watchcat Software validation vs design V&V? Other US Medical Device Regulations 27
M Initial Importer/Distributor and Software Validation IEC 62304 - Medical Device Software Life Cycle Processes 1
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
B A.I. diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 6
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 4
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
C SharePoint Contract Management Software General Information Resources 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3

Similar threads

Top Bottom