Could I destroy my DHR hard copy after 2 years after pdf'ing them ?

G

garnet

#1
I'm starting to convert DHR hard copies into PDF files to store them in our EDMS, I want to know if there is any regulation out there to dictate what to do with the hard copies, can I destroy them? should I keep them?. I know the 21 CFR part 820.180(b) talks about records retention for a period of time equivalent to the expected life of the device but in no case less than 2 yrs from the time of distribution. If there is no regulation about it, does anyone has a recommendation what should I do?:confused:
 
Elsmar Forum Sponsor

DanteCaspian

Quite Involved in Discussions
#2
If you are retain them digitally, then they are retained records.
Destroy the hard copies as soon as the files are scanned in a logical, obtainable file structure.
Assuming you have a backup system, this is actually more secure than just hard copies and should satisfy any auditor.
21CFR820.180 says you should retain for the life of the device. If your EDMS can trace all of this and link items at the end of there cycle, then the documents could be purged at the time of device destruction.

I would recommend you have the documents created and sent to you in digital to begin with. This will eliminate a function of scanning them.
 
Last edited:
M

MIREGMGR

#3
This thread is in an ISO 13485 section, perhaps implying a non-USA rules orientation for the OP's question, but the use of the terminology "DHR" sounds as if US FDA compliance may be involved.

Some records must be signed to indicate authorization, approval or responsibility. In general, FDA does not regard a simple copy or scan of a signature as having the same legal significance as the original physical signature. Therefore a simple copy or scan of a signed record is not equivalent to the original record.

The response prior to this one omits consideration of the FDA's stance on digital copies of records that contain a signature. Assuming that the records in your DHR all contain signatures:

If you are retain them digitally, then they are retained records.
In general this is incorrect, unless the digital system is Part 11 compliant...which is somewhat difficult and expensive to accomplish.

Destroy the hard copies as soon as the files are scanned in a logical, obtainable file structure.
This is very definitely incorrect, unless again the digital system is Part 11 compliant.

Assuming you have a backup system, this is actually more secure than just hard copies and should satisfy any auditor.
For a US FDA inspection, either QSIT 1/2 or For Cause, the last four words will be incorrect if the conditions above are not met.

See 21CFR Part 11 for the rules regarding digital copies of paper records, and digital keeping of mandated records in general.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
N Ways to Destroy Scrap Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
F Do we need to destroy all nonconforming scrap product - AS9100C AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
B Computer System Validation Records - Document Destroy Date - Animal pharma company Records and Data - Quality, Legal and Other Evidence 3
Sidney Vianna Managing risks - destroy your products to protect your brand. World News 1
D Can we destroy original paper files before retention period if we scan them? Records and Data - Quality, Legal and Other Evidence 17
ScottK Disposing of old hard drives - Best method to destroy data? After Work and Weekend Discussion Topics 17
R Ten Things Management Can Do To Destroy a Quality Culture Registered Visitor Articles Archive 16
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
E What are appropriate deviations for a LHR/DHR? (Medical Device Company) Manufacturing and Related Processes 3
P DHF, DMR and DHR in MDR? EU Medical Device Regulations 6
W Is it required to stamp obsolete hard copy DHR's "obsolete"? ISO 13485:2016 - Medical Device Quality Management Systems 6
R Are DMR (device master record) and DHR (device history record) inspected by FDA or audited by an NB ISO 13485:2016 - Medical Device Quality Management Systems 6
R In this type of Legal Manufacturer-CMO arrangement, what happens to the DHR? ISO 13485:2016 - Medical Device Quality Management Systems 1
M 13485- DHR requirement for a distributor? ISO 13485:2016 - Medical Device Quality Management Systems 1
Q Is a DHR enough to fulfill 13485:2016's Medical Device File requirement? ISO 13485:2016 - Medical Device Quality Management Systems 3
L Page Numbering requirement for DHR Report Records and Data - Quality, Legal and Other Evidence 3
V What is required in terms of the DHR, DMR, DHF? Other Medical Device and Orthopedic Related Topics 4
K DHR approval requirements for stand-alone software US Food and Drug Administration (FDA) 4
Q Incomplete Process Sheets Closure - DHR - Doc Control Document Control Systems, Procedures, Forms and Templates 3
Q DMR and DHR - Two requirements, One Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Are DHR and Design Dossier synonymous? US Food and Drug Administration (FDA) 9
W Maintaining Component Traceability in DHR (Design History Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Medical Device Service Records linked to DHR (Design History Record)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Better control of DHR (Design History Record) during processing Document Control Systems, Procedures, Forms and Templates 5
R Who owns the DHR (Device History Record) for the Medical Device? US Food and Drug Administration (FDA) 4
M DHR (Design History Record) Requirements - Concessions Quality Manager and Management Related Issues 12
E Traceability Requirements for Medical Device History Records (DHR's) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B DHR's (Device History Record) for Class 1 and 2 Medical Devices Not Required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 50
Q How much detail in DHR (Device History Record) is too much? US Food and Drug Administration (FDA) 3
C What is the Minimum Regulatory Requirement for Record Retention of DHR by Suppliers Records and Data - Quality, Legal and Other Evidence 9
I DHR (Device History Record) for Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
P DHR and components under deviation - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
T DMR/DHF/DHR/Batch Records/Master Batch Records ISO 13485:2016 - Medical Device Quality Management Systems 3
M DMR, DHR and DHF physical form 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Specific records to be retained for Class II devices per 820.184 DHR ISO 13485:2016 - Medical Device Quality Management Systems 8
S Device History Records (DHR) Component Traceability / Serial Number Requirements ISO 13485:2016 - Medical Device Quality Management Systems 16
R Sec. 820.120 Device Labeling & DHR - Count and Document All Labels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S Device History Record (DHR) Templates or Examples Wanted Document Control Systems, Procedures, Forms and Templates 5
C CMM Granite too hard General Measurement Device and Calibration Topics 4
J Argentina Asked for FSC Hard-Copy Edition Only Other Medical Device Regulations World-Wide 0
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
qualprod Non conformity, do nothing? Employee experiencing "hard times" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
supadrai Just found out the hard way that only one registration per manufacturer is allowed in Yemen, regardless of OEM or private label arrangement. Other Medical Device Regulations World-Wide 0
L Do you need to save hard copies of obsolete documents? Document Control Systems, Procedures, Forms and Templates 10
Q Do hard copies of quality records have to be retained? ISO 13485:2016 - Medical Device Quality Management Systems 2
A Alternative to keeping hard copy records that is 21 CFR part 11 compliant Document Control Systems, Procedures, Forms and Templates 0
S Are 2 Hard Copies of Procedures and Instructions Required? ISO 13485:2016 - Medical Device Quality Management Systems 6
P Document Control - Do hard copies of documents need to be signed? Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom