Does a website needs to comply with Part 11?

#1
Hello All,

Company X produces medical devices and puts them on sale to consumers via their own website. The website holds both product graphics and information for consumer. The information i.e. Graphics and Text (Literature) is Created, Modified and Approved in other systems , but is only uploaded on this website for viewing/download by the consumers.

As I read the definition of Electronic Record by FDA its states: Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system used to demonstrate compliance with FDA regulations.

Since the website is used to distribute information, does it falls under the compliance of Part11 for electronic record.

Also the website is hosted at AWS (cloud), will it be considered as Open System or Closed System?

Thanks
Zeeshan
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Is the distributed material required by regulation?

In my opinion, if something is in the cloud, it's an open system. You don't have complete control over access.
 
#3
Hi,

The content is marketing literature. I do know FDA classifies it as 'Labelling'
While the material is created, modified and approved elsewhere its uploaded on website for consumers to use/download.

Thanks
Zee
 

yodon

Staff member
Super Moderator
#4
If the marketing literature contains claims then, yes, it is labeling. Control should be pretty straight-forward by maintaining a document ID and revision and posting only immutable format (PDF... I know, I know, PDFs can be manipulated so you may need to put a few other controls on top).

I think there are levels of security with AWS so you may want to look into that to see what's most appropriate.
 
#5
How about audit trail? We would still need that Id imagine and so do these need to be created off the system or procedural controls (SOP) can be acceptable?
 

yodon

Staff member
Super Moderator
#6
You indicated you managed the changes outside of the cloud server so there shouldn't be any "touching" of the material once posted and thus I wouldn't see a need for audit trail. All the changes you make 'locally' would be done under standard design change control.
 
Thread starter Similar threads Forum Replies Date
E Does posting your IFU on your website constitute elabelling? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
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
A Kit Certification for 510(k)s on the CDRH website - Does anyone make these? Other US Medical Device Regulations 1
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 35
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 1
N Small Company - Internal audit process - Who does the audit? Internal Auditing 4
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
Watchcat Does "Similar Device" = "Predicate"? EU Medical Device Regulations 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 21
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Definition Open Audit - What does an Open Audit mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
I Does training have to be written? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P What does UPH/m² mean? Quality Tools, Improvement and Analysis 3
L "IATF-Compliant" IATF 16949:2016 certification? What does this mean? IATF 16949 - Automotive Quality Systems Standard 13
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
Sidney Vianna IAQG SCMH explains "positive risk"..........but does it? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 24
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Does pitch/increment/resolution of a ruled scale apply to measurement uncertainty as line item? Measurement Uncertainty (MU) 10
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
DitchDigger Boston Fire Code: Who Does What? (CAL TB 117-2013; CAL TB 133) Occupational Health & Safety Management Standards 2
GreatNate Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500? Manufacturing and Related Processes 0
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
K EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules? EU Medical Device Regulations 2
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
W How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
C Does ITAR apply to Exporters only? Other ISO and International Standards and European Regulations 6
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
R Does an RMA = a Customer Complaint Customer Complaints 4
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
M Informational Some things the EU MDR 2017/745 does not tell you, but you may need to know to comply with it effectively – Part 1 Medical Device and FDA Regulations and Standards News 0
S When does a Distributor become a Specification Developer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Does Least-squares (LSQ) simulate perfect roundness? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
C Does the company violates any regulation/standard by selling device without warranty ISO 13485:2016 - Medical Device Quality Management Systems 5
DuncanGibbons How does AS 9100D correlate or differ from NADCAP accreditation? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
Similar threads


















































Top Bottom