Floppy Disk Software Control - Floppy Disk with Software for Testing

Z

Zoey1

#1
I came across a situation where an operator was using a floppy disk with software for testing; this floppy has the write protection tab enable allowing writing capability. Does anyone know if this situation violates AS9100C 7.5.1.3, Control equipment, tools, and software programs?
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#3
I came across a situation where an operator was using a floppy disk with software for testing; this floppy has the write protection tab enable allowing writing capability. Does anyone know if this situation violates AS9100C 7.5.1.3, Control equipment, tools, and software programs?
I can't address the particular AS9100 aspect, but anyone can move the write-protect tab on a floppy (I'm assuming it's a 3.5" disk) at any time so it I don't see how it could be an issue.
 

yodon

Staff member
Super Moderator
#4
Standard (AS9100) notwithstanding, what was the floppy being used for? It's possible (I suppose) that the test script could call for a floppy disk (say, for temporary storage) so on the surface, it's not possible to say whether any controls were compromised.
 
Z

Zoey1

#5
:bigwave:The floppy was being used as a boot up disk for a operating system which was to support testing software with parameters.

Thank you all for your input!
 
Thread starter Similar threads Forum Replies Date
Marc Farewell to the Floppy Disk After Work and Weekend Discussion Topics 32
S Control of Data Floppy Disks from Milacron Ferromatik molding machines Document Control Systems, Procedures, Forms and Templates 2
Ninja Windows 10 100 % disk use after update Coffee Break and Water Cooler Discussions 33
N Gage R&R - Tolerance - APQP Forms Disk from the AIAG - Formulas IATF 16949 - Automotive Quality Systems Standard 3
D Core Tools Forms Disk IATF 16949 - Automotive Quality Systems Standard 1
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) 2
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 4
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
B Complaint Records - Accessing records on Easy Track Software Records and Data - Quality, Legal and Other Evidence 3
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
D Safety data sheets software REACH and RoHS Conversations 2
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Missing 1m visual alarm signal in case of software/display failure, mitigation? ISO 14971 - Medical Device Risk Management 3
B Software service provider as critical supplier ISO 13485:2016 - Medical Device Quality Management Systems 5
S Asterisk in DOE minitab software Using Minitab Software 23
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
bruceian Software Quality Metrics Software Quality Assurance 11
optomist1 How Secure Are Our Software Systems Software Quality Assurance 7
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L Radiology software Class I exemption Medical Device and FDA Regulations and Standards News 3
O Software for comparing text of PDF files Contract Review Process 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M Recurrent event analysis software (python) General Auditing Discussions 2
Y UL 1998 Standard: software classes Software Quality Assurance 0
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
S IEC 62304 software costs and time Medical Device and FDA Regulations and Standards News 3
S IEC 62304 - Software verification cost IEC 62304 - Medical Device Software Life Cycle Processes 3

Similar threads

Top Bottom