Elsmar Cove Quality and Medical Device Discussions

The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > US Medical Device Regulations > 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

What are the requirements of traceability in FDA's Regulations


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links



Courtesy Quick Links

Links that Cove visitors will find useful in your quest for knowledge:


International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Atul's
Quality Forum Online

Howard's
International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Related Topic Tags
fda (food and drug administration), process capability, traceability of parts materials and products
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 24th August 2008, 01:40 AM
hafor's Avatar
hafor

 
 
Total Posts: 8
Question What are the requirements of traceability in FDA's Regulations

Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks

Sponsored Links
  Post Number #2  
Old 24th August 2008, 02:31 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: what are the requirements of traceability in FDA's Regulations

Is your inquiry in regard to Traceability per 21 CFR 820.65, or Device Tracking per www.fda.gov/cdrh/devadvice/353.html and 21 CFR 821, or general operations with critical raw materials that are obtained in batches and are known to have a potential for significant batch-to-batch variation?
Thanks to MIREGMGR for your informative Post and/or Attachment!
Sponsored Links

  Post Number #3  
Old 24th August 2008, 02:43 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,910
Re: what are the requirements of traceability in FDA's Regulations

Quote:
In Reply to Parent Post by hafor View Post

Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks
Traceability, as mentioned by MIREMGR is covered by 21 CFR 820 under Sec. 820.65 and states as below -

Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.

So going back to your earlier question, all concerns with the raw material (incl Material review Board recommendations) should be part of Device History Record (DHR).
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #4  
Old 24th August 2008, 03:14 AM
harry

 
 
Total Posts: 6,273
Re: What are the requirements of traceability in FDA's Regulations

Quote:
In Reply to Parent Post by hafor View Post

Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks
Welcome,

I am assuming that you are still new and will guide you through our search feature. Just go to search, then advance search and key in 'fda + traceability' as key words and you will get the following:

Identification and Traceability in Medical Device Tracking - FDA Requirements


Procedure on Traceability - FDA audit finding
Thanks to harry for your informative Post and/or Attachment!
  Post Number #5  
Old 24th August 2008, 11:10 AM
hafor's Avatar
hafor

 
 
Total Posts: 8
Laughing Re: What are the requirements of traceability in FDA's Regulations

Thanks a lot for all of your answers.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > US Medical Device Regulations > 21 CFR Part 820 - US FDA Quality System Regulations (QSR)

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Are we doing enough to meet Identification and Traceability 7.5.3 Requirements? dalzell40 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1 29th August 2013 12:11 PM
Traceability Requirements ingabramrobles TL 9000 Telecommunications Standard and QuEST 5 18th June 2009 08:59 AM
Ford Lot Traceability Requirements Cndngirl - 2012 Customer and Company Specific Requirements 9 20th March 2009 09:00 AM
Traceability of Requirements in the V-Model temujin Qualification and Validation (including 21 CFR Part 11) 3 28th June 2008 01:52 AM
Traceability of Raw Materials - What are the Requirements? Michel Saad QS-9000 - American Automotive Manufacturers Standard 11 10th August 2000 09:11 AM



The time now is 10:28 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 


NOTE: This forum uses "Cookies"

Elsmar Cove Quality and Medical Device Discussions