IT validation for a paper based MD repair company QMS

#1
Hello,
We are a small MD repair company with a paper based QMS. I wondered if we were concerned by the requirements related to IT validation. The only software we have are related to inventory or operations (from repair order to delivery to customer). Do we need to validate them and do we need to write a procedure on it. I wondered if we could use the risk assessment to justify that these software have a very low impact on product conformity.
Thank you in advance for your help!
Best regards,
 
Elsmar Forum Sponsor

LukasLosigkeit

Starting to get Involved
#2
Hello,
We are a small MD repair company with a paper based QMS. I wondered if we were concerned by the requirements related to IT validation. The only software we have are related to inventory or operations (from repair order to delivery to customer). Do we need to validate them and do we need to write a procedure on it. I wondered if we could use the risk assessment to justify that these software have a very low impact on product conformity.
Thank you in advance for your help!
Best regards,
ISO 13485:2016, 4.1.6 says, you shall document procedures for the validation of the application of computer software used in the QM system. And such software shall be validated prior to use.

To be fully compliant, you need to validate software within your QMS.

Note: But not all software used in your company is software that you use within your QMS.

I guess that the software described by you is part of the QMS, as you said it has little impact on product conformity. Therefore, validation is required (and a procedure). But considering the risk basked approach, your validation does not need to be as extensive as for a high risk software.
 

yodon

Staff member
Super Moderator
#3
Good feedback by @LukasLosigkeit. You'll want to have documented rationale for the approach you take. What can happen if the software fails? Are you maintaining service/repair records in the software? If so, that may kick things up a notch since those are required records and need to be analyzed.
 
#4
Thank you for your answer! The only risk I see : not using the proper part to repair the MD because of failure of the software.
But some controls are done by the operator to check that it is the right part. If i write a procedure explaining how we mitigate any risk of failure of the software, is it ok? How is it possible to validate a software we have been using for years ?
 

LukasLosigkeit

Starting to get Involved
#5
Thank you for your answer! The only risk I see : not using the proper part to repair the MD because of failure of the software.
But some controls are done by the operator to check that it is the right part. If i write a procedure explaining how we mitigate any risk of failure of the software, is it ok? How is it possible to validate a software we have been using for years ?
The easiest way to validate the software is the black box approach.

What goes in that box? What is expeted to come out as an answer?
Create test cases where you test the things you do with the software in routine use. Test these functions.
Consider also min/max values.
e.g. you can enter at least 0 and max 255 pieces per item. You should definitely test such values.

Do you know how to validate in general / how to perform software validation?
 

yodon

Staff member
Super Moderator
#6
How is it possible to validate a software we have been using for years ?
Let me bookend the response from @LukasLosigkeit. First establish the requirements for what your use of the software is. Then do the testing described. Since you've been using this for years, the effort is considered a "retrospective validation" which means that you have to consider the lack of validation for everything in the past. This is mostly only an issue if any issues are found in testing. If you find issues, you need to consider what that meant to past use and whether there was any impact on product or regulatory compliance from using the software with the issue.

Since I presume you are operating under 13485 and you were using non-validated software, it's probably best to run this under a CAPA since it sounds like you don't have the process in place at all.

Bear in mind that validation is not intended to be a one-time effort. You have to consider whether changes warrant re-validation. Changes are not limited to the software itself. You can have changes in underlying software (e.g., database engines), changes to use profile (new use scenarios, expanded number of users), changes to the OS under which the software runs, etc. This is why I suggest running under a CAPA to flesh out the complete process and not just test.
 
Thread starter Similar threads Forum Replies Date
S Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
Z Is IQ necessary for laser marking validation? EU Medical Device Regulations 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 2
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 1
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
T Annual Validation as a detection mode on a PFMEA? FMEA and Control Plans 5
B TMV - Selection of TM's for Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
P Human Factors / Usability validation in the time of COVID Human Factors and Ergonomics in Engineering 9
C Template for Excel Validation Reliability Analysis - Predictions, Testing and Standards 5
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
Stoic Manual soldering processes - 100% verifiable, or always requiring validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Rees System Validation Qualification and Validation (including 21 CFR Part 11) 1
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
Y Retrospective Validation - Class I device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
M Validation of two nearly identical products Other Medical Device Regulations World-Wide 5
J Requested Validation plan and reports Manufacturing and Related Processes 4
S Validation Records - Very young QMS Qualification and Validation (including 21 CFR Part 11) 2
M Test method validation - Is MSA (MSA1, MSA2, MSA3 and linearity) a good solution? Medical Device and FDA Regulations and Standards News 1
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 8
W ASTM F1929 dye penetration test - Validation for in-house testing ISO 13485:2016 - Medical Device Quality Management Systems 13
Bev D Verification and Validation of Measurement Systems Misc. Quality Assurance and Business Systems Related Topics 0
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
D Software validation in Medical Equipment Other Medical Device and Orthopedic Related Topics 20
K Validation of new machine (second machine of the same type) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
A Literature review/HACCP validation of metal detection Food Safety - ISO 22000, HACCP (21 CFR 120) 0
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
A Our auditor told if we didn't have a patent we would have to do a validation or verification ISO 13485:2016 - Medical Device Quality Management Systems 6
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Clean Line Validation ISO 13485:2016 - Medical Device Quality Management Systems 6
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
H EO Sterilization Validation - Sterility Testing and Load Configuration Other Medical Device Related Standards 1
C Looking for simple Software Validation IQ templates. Qualification and Validation (including 21 CFR Part 11) 4
R Which pieces of equipment require equipment validation? ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom