Has anyone here had any experience with PQ-FMEA software?

A

Analyticalman

DCHill said:
Has anyone here had any experience with PQ-FMEA software? If so, please share your thoughts.
Click to expand...
I use it in the pharmaceutical area (quality by design). I find it simple to use and the Tree mode for setting up the FMEA worksheet is simple and intuitive. They have recently squashed a bug which made the display too small at some screen resolutions and you can now zoom in easily which makes it good for sessions where you are projecting the worksheet. Developer is also responsive to email queries.

Sent from my SM-T810 using Tapatalk
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Marc Has anyone here gotten Gigabyte Fiberoptics (Internet) to home? Coffee Break and Water Cooler Discussions 3
C Has anyone here set up a Quality Clinic? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
A Service commitment - Has anyone here already worked with this approach? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Has anyone implemented the Adobe Acrobat Sign Validation Pack to be 21 CFR Part 11 Compliant? ISO 13485:2016 - Medical Device Quality Management Systems 9
S Has anyone had experience with Intellect eQMS? ISO 13485:2016 - Medical Device Quality Management Systems 1
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
H Has anyone undergone MDR FQA review yet? EU Medical Device Regulations 10
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 15
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
Dobby1979 FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
L Has anyone heard of the 2 pan system? Manufacturing and Related Processes 6
D Has anyone undergone a BARDA (HHS) audit as part of their grant process? Other Medical Device Regulations World-Wide 0
Sidney Vianna LinkedIn bug - Anyone has any idea of how to fix this? Posts not showing for me in a Group feed. Coffee Break and Water Cooler Discussions 2
K Has anyone used QAI for training? Training - Internal, External, Online and Distance Learning 7
S Has anyone completed IATF 16949 Certification - Share your Audit Experience? IATF 16949 - Automotive Quality Systems Standard 2
S Has anyone created a Turtle Diagram reflecting the new ISO 9001:2015 Structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Has anyone done a Gage R&R for Spectrophotometer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
T Has anyone completed the AS9100D Quality Manual transition? Quality Management System (QMS) Manuals 1
D Has anyone taken the AS9100 Delta course / exam? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37
D Medica show in Dusseldorf - Has anyone else gone? Other Medical Device and Orthopedic Related Topics 3
A AS9100C to D - Has anyone done a gap analysis? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T Has anyone been through the ISO 14001:2015 process? ISO 14001:2015 Specific Discussions 12
M Has anyone had their electronic system scrutinized in an FDA inspection? Records and Data - Quality, Legal and Other Evidence 16
P Has anyone ever heard of the Eastern Weighing and Inspection Bureau? Calibration and Metrology Software and Hardware 1
M Has anyone successfully challenged the new IATF site extension change? IATF 16949 - Automotive Quality Systems Standard 36
R Does anyone know why the TC 176 website has been hijacked by CSA? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
GStough Rx-360 - Has Anyone Used This and What Was Your Experience? Supplier Quality Assurance and other Supplier Issues 3
A Has anyone made an ISO9001:2015 vs. ISO9001:2008 Matrix ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
I Has anyone read BIP 0115:2014? ISO 13485:2016 - Medical Device Quality Management Systems 5
D ?Pa? Capability Index - Has anyone ever heard of this? Capability, Accuracy and Stability - Processes, Machines, etc. 5
optomist1 Has anyone recently taken the GD&T ASME Y14.5M Certification Exam Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
T Has anyone considered what logic is? Coffee Break and Water Cooler Discussions 23
Jim Wynne Has Anyone Had Trouble with IMDS 8.0? RoHS, REACH, ELV, IMDS and Restricted Substances 17
G Has anyone used shlomo Aviv-lean consultant? Lean in Manufacturing and Service Industries 1
M Has anyone purchased their powerball tickets? 17 May 2013 Coffee Break and Water Cooler Discussions 8
T Has anyone done both Quality and Facility Security Officer (FSO) roles ? Career and Occupation Discussions 8
M Has anyone used SGS as a CB (Certification Body)? Registrars and Notified Bodies 4
R Mix Multi-Site/Individual Certification - Has this ever happened to anyone? Miscellaneous Environmental Standards and EMS Related Discussions 14
B Has anyone used Arena Software Simulation? Process Maps, Process Mapping and Turtle Diagrams 10
C Has anyone used GageWare Software? Quality Assurance and Compliance Software Tools and Solutions 4
M Has anyone used "Paradigm 3" software to Control their Quality or Management System? Quality Tools, Improvement and Analysis 2
Q Has Anyone Heard of Quality University (Online Courses) Training - Internal, External, Online and Distance Learning 2
P Has anyone ever heard of "Quality Gates" (Volkswagen term?) - APQP and PPAP APQP and PPAP 11
A Has anyone tried a DAC (Digital to Analog Converter)? After Work and Weekend Discussion Topics 5
I Has anyone ever heard of Registrar QSRD-International? Registrars and Notified Bodies 36
M Has anyone of you have experience with the World Class Manufacturing system? Lean in Manufacturing and Service Industries 6

Similar threads

Top Bottom