Requirement to Identify Changes to record in ISO 13485 : 2016

A1S2H3I4T5H

Starting to get Involved
#1
Hey Guys,

Can u please help in figuring out what "Changes to record" means and how to incorporate in our system ?? (ISO 13485:2016, 4.2.5)

Thanks.
 
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
You're referring to this paragraph, I presume:

Records shall remain legible, readily identifiable and retrievable. Changes to a record shall remain identifiable.

There are a variety of ways a record can be changed so you have to have a strategy on how this is managed. Consider, for example, a lot production record (maybe a traveler). As it is goes through the process, someone may make an entry and someone downstream may need to correct that entry. How will you be able to identify who made the original entry, what the original entry was (legible), and who made the change?

If you are dealing with electronic records (refer to Part 11), you will need to ensure that there's an audit trail with the above information for each change. (This actually applies to all entries, not just changes). So if your traveler above is an electronic record and all entries are done electronically, as well as the downstream change, the system has to enable capture of the audit trail with the identifying information.

Hope that makes sense. If you have specific questions / scenarios, it might help to share them to help us give better responses.
 

Ronen E

Problem Solver
Moderator
#4
Changes to a record shall remain identifiable.
In my understanding this comes down to the following:
1. The change must not remove/obscure the original information.
2. The person making the change must be identified in connection with the specific change.
3. The date that the specific change is made must be captured in connection with it.
4. Unless the authority to make that specific change is obvious, it needs to be documented somewhere that is reasonably easy to track (eg a change control record).

As Marcelo suggested, in paper form the trivial way of doing so is striking through the original information, adding the new one, signing-off and dating the change in close proximity. The downsides of this practice are that sometimes the individual can't be readily identified from the signature (or initials, as some orgs require), and the authority trail is sometimes not that obvious (or well documented).

For electronic records see yodon's comments. The 4 principles I listed above apply just the same.
 

rlangeZMC

Starting to get Involved
#5
I also have the same issue but my example will be a completed COA.

We have updated a test value, it was initially typed as N/A but now, for whatever reason, they want to go back and do the test and add it to the COA. I'm sure we don't want to cross anything out and make it look bad and I'm sure the customer doesn't want a COA that looks like that. Would we be allowed to put an * next to the added data and put the * in the footer stating that the data was added on MM/DD/YYYY? We would save the new COA with the lot number and date of update in the title so it was obvious. Ex: 123456 04132018. The previous COA would be obsoleted and marked as such, 123456 - obsoleted 04132018 then placed in an obsolete folder within the original folder. If you right-click over the document, it shows you who updated it. Does that cover: legible, readily identifiable and retrievable? :thanx:

Thoughts? :bigwave:

We already have a good way of controlling documents but I have so many thoughts about controlling records. It's a whole other game.
 
Thread starter Similar threads Forum Replies Date
V How to identify Customer Specific Requirement If is not provided by Customer Customer and Company Specific Requirements 5
P Requirement to create an asset register and identify all Key equipment? IATF 16949 - Automotive Quality Systems Standard 2
W New Customer Requirement - Identify key performance measures and Leading Indicators Customer and Company Specific Requirements 2
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
S AS9120 - New Internal Auditor Training requirement? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
H Is it a requirement for run charts to have inspection data or can it have just a pass/fail check mark Records and Data - Quality, Legal and Other Evidence 1
I Brazil clinical data/trial requirement Other Medical Device Regulations World-Wide 1
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 11
D Packaging requirement ? EU Medical Device Regulations 0
C Isolation requirement for USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C Creepage requirement Wearable ECG IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
V IATF 16949 GM CSR 10.2.4 Error-proofing requirement IATF 16949 - Automotive Quality Systems Standard 2
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 3
CaliperJim Uncertainty and Accuracy Requirement Deviation Provision General Measurement Device and Calibration Topics 2
Y Software to Manage IEC 62304 Traceability Requirement IEC 62304 - Medical Device Software Life Cycle Processes 3
Ajit Basrur Where to find a pagination requirement as "Page x of y"? ISO 13485:2016 - Medical Device Quality Management Systems 7
T Logistics and 3PL regulatory requirement in India for Pharmaceuticals and Med devices Other Medical Device Regulations World-Wide 0
G ISO 9001 - when implementing customer requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
H Regarding external surface temperature limit requirement for lab incubators. CE Marking (Conformité Européene) / CB Scheme 2
H OTC DRUG Private Labelling Distributor: GMP REQUIREMENT ISO 13485:2016 - Medical Device Quality Management Systems 0
R UDI Requirement at home patient use EU Medical Device Regulations 2
L Definitions Requirement ISO 14971 - Medical Device Risk Management 10
D What distributor requirement should we (manufacturer) require from the Distributor? EU Medical Device Regulations 0
Y Brazilian lab requirement for medical device manufacture Other Medical Device Regulations World-Wide 1
J QTC Requirement as per API 6A-21st Edition Oil and Gas Industry Standards and Regulations 1
J NADCAP Root Cause - Misinterpretation of Checklist Requirement Various Other Specifications, Standards, and related Requirements 5
eldercare Multi-Site ISO/AS Certification Requirement for some sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
H FAI Requirement After Moving CNC Machine? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
S Biocompatibility requirement for electrode adapters Other Medical Device Related Standards 1
briteme4 AS9102 FAIR Requirement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Put on escalation by customer? is there a requirement to notify registrar? IATF 16949 - Automotive Quality Systems Standard 6
E Translation requirement labels EU Medical Device Regulations 4
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
C Requirement for Revision of Standard in all Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K ROHs compliance requirement REACH and RoHS Conversations 10
E Language requirement DoC EU Medical Device Regulations 6
I QMS monitoring, measurement, analysis and evaluation requirement - Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Requirement for Signature on Document Document Control Systems, Procedures, Forms and Templates 13
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
W Pfmea function requirement and failure mode FMEA and Control Plans 6
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 8
J When PPAPs are not a contractual requirement APQP and PPAP 9
I Overwhelmed with attribute MSA requirement for visual inspection IATF 16949 - Automotive Quality Systems Standard 11
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3

Similar threads

Top Bottom