Do hard copies of quality records have to be retained?

QE1993

Involved In Discussions
#1
For example, we scan all of our DHR's into our backed up network. Our Doc. Control employee reviews the scanned DHR's to ensure legibility and that all pages were scanned. We toss the hard copies after that.

Our sister company recently informed us that they retain all hard copies and when their internal storage gets full, they outsource the storage to an outside facility. The QA director's reasoning was that the FDA considers them to be source documents and require they be permanently retained (well, for 55 years).

I reread CFR 820 and ISO 13485's section on control of records, and did not read anything about source documents and hard copies being permanently retained.

Does anyone have any insight into this?
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
You will want to look over FDA 21 CFR Part 11.

Curious: where did you come by the "55 years"? By 21 CFR 820.180:
"(b) 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."

Is the expected life of your device 55 years?
 

Mark Meer

Trusted Information Resource
#3
Also, here is an older thread discussing this.

MIREGMGR's post on that thread concludes:

...a scan or other image of a document carrying an original physical signature is acceptable only if a separate process at the time of scanning or imaging has verified that the scan or image is a true copy, and that separate process has been attested with the signature of the responsible individual.
Note that this only relates to US FDA policy on documents with signatures, and the thread is old (2009), so I don't know if the FDA have since modified/clarified this position...
 
Thread starter Similar threads Forum Replies Date
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
L Do you need to save hard copies of obsolete documents? Document Control Systems, Procedures, Forms and Templates 10
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
G Document Control - Are hard copies required in addition to soft copies maintained? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
L Does ISO 9001 require that hard copies of documents be archived? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
V Hard copies from 10-20 years ago - Document Control and Retention Times question Document Control Systems, Procedures, Forms and Templates 19
C Do you still collect hard copies of objective evidence when auditing? General Auditing Discussions 20
K Are Hard copies necessary? Document Control Systems, Procedures, Forms and Templates 4
Marc Hard Copies from Electronic Media Document Control Systems, Procedures, Forms and Templates 1
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
qualprod Non conformity, do nothing? Employee experiencing "hard times" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
W Is it required to stamp obsolete hard copy DHR's "obsolete"? ISO 13485:2016 - Medical Device Quality Management Systems 6
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
A Alternative to keeping hard copy records that is 21 CFR part 11 compliant Document Control Systems, Procedures, Forms and Templates 0
W Great way to work hard for your career Career and Occupation Discussions 4
R Height gauge to measure short hard to access heights General Measurement Device and Calibration Topics 3
A Identification of Customer Property: Customer-Supplied Thumb Drives & Ext Hard Drives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Having a hard time closing CAR/ PAR Nonconformance and Corrective Action 13
D Hard cut off date for certificates to be issued against ISO 9001:2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
S Why is it so hard to close out the CAPAs ? Nonconformance and Corrective Action 16
G Could I destroy my DHR hard copy after 2 years after pdf'ing them ? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Best Fit Alignment vs. Hard Datums Calibration and Metrology Software and Hardware 5
H Layered Process Audit Hard Copy Records Retention Records and Data - Quality, Legal and Other Evidence 6
N Boss is too hard on me.... Career and Occupation Discussions 48
C Hard Copy Documents not in Fireproof Cabinets - Document Storage Questions... ISO 13485:2016 - Medical Device Quality Management Systems 3
I MDNR (Medical Devices National Registry) and Hard Copy Other Medical Device Regulations World-Wide 3
T Eliminating "Hard Copy" Manuals from our Office and Shop Floor - Documentation Medium ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna Why are GOOD Internal Auditors so hard to find? Internal Auditing 35
P Hard Milling Process - Dealing with Within Part Variation for SPC Statistical Analysis Tools, Techniques and SPC 18
Q Uncontrolled Hard Copy (Paper) Document Validity Period Document Control Systems, Procedures, Forms and Templates 12
B Hard Gage Rentals - Thread Gages or Thread Rings General Measurement Device and Calibration Topics 3
Marc Tearing Apart a McAfee Hard-Sell Anti-Virus Ad After Work and Weekend Discussion Topics 6
Jen Kirley Trying to back up a dead hard drive - how to do it? Coffee Break and Water Cooler Discussions 17
S Auslogics Defrag - Hard Drive Defragmentation After Work and Weekend Discussion Topics 9
J U.S. National Archives offers reward for missing hard drive After Work and Weekend Discussion Topics 1
C Specification (hardness) for stainless steel SUS 310 3/4 Hard Manufacturing and Related Processes 3
BradM It's a hard luck life Funny Stuff - Jokes and Humour 0
S MSDS Records - Is a hard copy required if I have a scanned copy? Miscellaneous Environmental Standards and EMS Related Discussions 14
I FMEA Detection Rating - What is Soft or Hard? FMEA and Control Plans 7
P Six Sigma Certification Test - How hard is the Six Sigma Certification Test? Professional Certifications and Degrees 6
ScottK Disposing of old hard drives - Best method to destroy data? After Work and Weekend Discussion Topics 17
J What Hardness for .090 Thick Silicone Bronze, Extra Hard Temper (cda 65500-h06) Manufacturing and Related Processes 5
M Does ISO9001 require that a hard copy of a signed procedure be kept? Document Control Systems, Procedures, Forms and Templates 7
J MS Windows XP Pro Hard Drive Defrag (defragmentation) question After Work and Weekend Discussion Topics 26
J Engineering having a hard time defining Objectives - ISO 9k2k 5.4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Marc 50th Anniversary of the First Hard Drive - Sept. 13, 1956 After Work and Weekend Discussion Topics 8
J New QA Manager - Top Management is Divided - Between a rock and a hard place IATF 16949 - Automotive Quality Systems Standard 73
D Hard to change factors in DOE (Split Plot Designs) - Injection Molded Parts Design and Development of Products and Processes 15

Similar threads

Top Bottom