SBS - The best value in QMS software

Images of Product for Automated Process - How long to keep?

PeterLe

Involved In Discussions
#1
Hello everyone,

We are developing an automated process to inspect one of our components which take images and conduct a pass/fail result. Currently we are visually inspecting it 100%. One issue right now we have is, currently as our Material Requirements Specification document states X TB will be installed into the system, which is only 2-3 days worth of images. 2-3 days sound way too little. Is there a requirement per FDA or general best practices on how much data to keep? Archiving looks like the way to go but how much data should we keep?

Any advice would be much appreciated! Thanks!
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
The FDA regulations (21 CFR 820.180) establishes the record retention period:

All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.

If the images are used as evidence of passing any of the in-process or final acceptance tests, I would think they would be considered part of the DHF and, thus, be retained per the regulation. (There's another rabbit hole to consider: 21 CFR 11 - electronic records.)
 

PeterLe

Involved In Discussions
#3
Hello Yodon. I appreciate the response. These pictures are not included in batch records/DHF. Would that make a difference?
 
Thread starter Similar threads Forum Replies Date
T Detailed Product Images for the Off the Shelf Items Other Medical Device Related Standards 2
J IEC60601-2-18 - Endoscopic Surgical Monitor System Images IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
V Study About Raw Materials (Polymers) - DSC, FTIR,TGA, and SEM Images Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
A FDA guidance for MDDS, Medical Images Storage, Medical Image Communications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
Marc New technology produces spectacular 3-D Images of Ancient Artifacts Coffee Break and Water Cooler Discussions 0
A Need help with a Kappa Study (MSA) - Reviewing x-ray Images Six Sigma 11
B China Secret Experiments - Images Available Coffee Break and Water Cooler Discussions 6
A Google Images Fun Funny Stuff - Jokes and Humour 7
B Favorite Funny Images.... Funny Stuff - Jokes and Humour 16
M Use of Images as Evidence Document Control Systems, Procedures, Forms and Templates 1
A Migrating from whole product CE marking to modular approach CE Marking (Conformité Européene) / CB Scheme 1
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 0
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
R Compatibility studies - combination product CE Marking (Conformité Européene) / CB Scheme 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
dinaroxentool Selling a product in Both UK and EU after Brexit UK Medical Device Regulations 9
P EU MDR Translation of Product Name EU Medical Device Regulations 1
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
Sidney Vianna Informational APQP4Wind - Advanced Product Quality Planning for the Wind Power Supply Chain APQP and PPAP 3
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
S How long does it take to register a product with MHRA? UK Medical Device Regulations 4
D Classification of product for clinical trials EU Medical Device Regulations 14
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
B Internal Auditor Competency - Product Auditors Internal Auditing 9
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
S AS9120B - 8.5.2 Delivering Split Product AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Classification of a product according to MDR EU Medical Device Regulations 3
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
L AS9100 - Product and Service Provision 8.5.1q AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
Felony Melony New Product Launch - Safe Launch Customer and Company Specific Requirements 1
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
A Software bug fixes after shipping a product EU Medical Device Regulations 3
silentmonkey How to measure severity if my product is designed for emergency use and failure would result in death? ISO 14971 - Medical Device Risk Management 9

Similar threads

Top Bottom