Software and Web Site Development - Need help with interpreting 7.5.2

L

lrl116

#1
Can anyone offer me some advice to clause 7.5.2? I am working in a software development and web site development company. In addition we also provide services to the government to file documents. Our projects can range from anywhere to 1 month to years. Would this clause apply to these types of services?

Is it possible that I can take an exclusion from this clause?
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Re: Need help with interpreting 7.5.2

Can anyone offer me some advice to clause 7.5.2? I am working in a software development and web site development company. In addition we also provide services to the government to file documents. Our projects can range from anywhere to 1 month to years. Would this clause apply to these types of services?

Is it possible that I can take an exclusion from this clause?
7.5.2 is applicable to:
...any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
Does that describe any of your products or services?
 
C

chergh - 2008

#3
Re: Need help with interpreting 7.5.2

7.5.2 can certainly be excluded, and often is in my experience, along with anything else in section 7 of the standard, as long as you have justification.

The key question in my opinion is are there any of your processes or services where "the resulting oiutput cannot be verified by subsequent measuring or monitoring"

The best example of this is probably destructive testing as once the testing is complete you cannot go back and verify the result.
 
L

lrl116

#4
Re: Need help with interpreting 7.5.2

Those comments do help. I think in the case of a project where someone is filing documents it may apply. Since you can not monitor this person throughout the day a mistake is only apparent when the customer goes to search for a document and finds it was filed improperly.

Does this sound right?
 
C

chergh - 2008

#5
Re: Need help with interpreting 7.5.2

Not really as you can check this after the filing has been done.

If the service offered was to destroy documents then 7.5.2 would probably apply as you could not subsequently verify this. If the documents were not destroyed, e.g. found in a drawer or somethin, then this would only become apparent after the service had been delivered
 
F

fuzzy

#6
Re: Need help with interpreting 7.5.2

Those comments do help. I think in the case of a project where someone is filing documents it may apply. Since you can not monitor this person throughout the day a mistake is only apparent when the customer goes to search for a document and finds it was filed improperly.

Does this sound right?
At first I said "No", then "Yes":confused: , but now I'm back to "No'.

Key part to consider is "output cannot be verified by subsequent monitoring or measurement".

Is it impossible to monitor or measure your filing process output (document placed correctly) after it has been delivered? No. You can audit/ monitor / measure accuracy via various methods (manual / electronic / etc.).

"No" is the answer and you should waive 7.5.2 in your QMS manual scope statement.:2cents:
 
Thread starter Similar threads Forum Replies Date
C Software validation - Off The Shelf Software - Web hosted ISO 13485:2016 - Medical Device Quality Management Systems 6
C Web based Complaint Software which interfaces with our Enovia system Document Control Systems, Procedures, Forms and Templates 0
T Web-based Software Device - Servers & 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L Data Management and Web based Document Control Software Document Control Systems, Procedures, Forms and Templates 18
B Web Based Quality Management Compliance Software Quality Assurance and Compliance Software Tools and Solutions 5
V Customer Survey Software - Software or a web host to perform customer surveys Quality Assurance and Compliance Software Tools and Solutions 2
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 3
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) 3
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

Similar threads

Top Bottom