ISO 13485 7.5.6 Validation - Off the shelf Software

QuinnM

Involved In Discussions
#1
Hi,

We develop software under medical devices. Our software team is using a well established version control software for among other things capturing code changes. 13485 7.5.6 Validation of processes for production and service provision has "The organization shall document procedures for the validation of the application of computer software used in production and service provision."

I am interpreting this to mean the off the shelf software we use for version control is required to be validated. Is my interpretation correct?

Thanks
Quinn
 
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
Yes... but remember that you can frame your validation efforts around the risk. No need to go too crazy. Most likely, any failures would be either immediately caught in compiles or regression testing. You'll want to consider your implementation of any hierarchical controls (confirm that not everyone is an admin, for example). If there's a back-end server, you'll want to ensure it's set up per the provider's specs (which may include some database engine requirements as well as general things like memory and OS). It'd be a good idea to assess known issues reported by the provider and confirm that you're unaffected (if so - or how you deal if you are).
 

QuinnM

Involved In Discussions
#3
yodon I looked at 13485 7.5.6 and (I liked your language) no need to go crazy, for the validation is framed around risk.

Thanks Quinn
 

mihzago

Trusted Information Resource
#4
A simple assessment of the things yodon mentioned should be sufficient.
You may sometimes come across expectation that testing is required. It is not. Testing is one of the tools in your validation toolbox, but is not necessary or even suitable in all cases.
 
Thread starter Similar threads Forum Replies Date
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 16
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D ISO 13485 - Equipment validation , qualification Qualification and Validation (including 21 CFR Part 11) 6
R ISO 13485 Software validation procedure and Quality Objectives Monitoring wanted Document Control Systems, Procedures, Forms and Templates 1
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
J ISO 13485 - 7.5.2 cleanliness , 6.4.2 validation of special processes, and 6.4.2 contamination ability to be exempt? ISO 13485:2016 - Medical Device Quality Management Systems 5
T Software Validation Certificate (ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 19
C Software validation (4.1.6 ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 20
R CNC Software Validation requirements as per ISO 13485:2016 Other ISO and International Standards and European Regulations 8
S What is the clause in ISO 13485 for SAP Software Validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Process Validation of QMS Software ISO 13485: 2016 Cl. 4.1.6 ISO 13485:2016 - Medical Device Quality Management Systems 26
S Software Validation – Clause 4.1.6 of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 12
R ISO 13485 Validation and CAR Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 13485 - Client Specific Validation and CE Marking CE Marking (Conformité Européene) / CB Scheme 3
R ISO 13485 Software Validation Requirements - Help needed ISO 13485:2016 - Medical Device Quality Management Systems 4
F ISO 13485 & FDA Requirements - What kinds of software require validation? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Validation of Sterilization Procedures - ISO 13485 Section 7.5.2.2 Document Control Systems, Procedures, Forms and Templates 4
A ISO 13485, Document Control and Software Validation ISO 13485:2016 - Medical Device Quality Management Systems 9
N Validation of Special Processes - N/A of ISO 13485 Clause 7.5.2 ISO 13485:2016 - Medical Device Quality Management Systems 12
C Process Validation procedure for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
A Clean Room - Standards or some type of Clean Room Validation - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 17
M Validation Requirements - ISO 13485 / MDD Technical File ISO 13485:2016 - Medical Device Quality Management Systems 7
P Guidance on ISO 13485 Section 7.5.2. about Software Validation ISO 13485:2016 - Medical Device Quality Management Systems 15
A How to do Equipment Validation - Establishing our ISO 13485 QMS procedures Qualification and Validation (including 21 CFR Part 11) 34
T Validation Requirements: ISO 9001 vs. ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 10
T Contradictions in Medical Device Verification vs. Validation - ISO 13485 Qualification and Validation (including 21 CFR Part 11) 35
E Contract manufacturer seeking help understanding ISO 13485 Validation requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
R Design Validation and Clinical Evaluations to meet ISO 13485 requirements Design and Development of Products and Processes 3
K Software validation question - Contract Manufacturer - ISO 13485 implementation ISO 13485:2016 - Medical Device Quality Management Systems 2
P ETO Sterilization Validation Process and an NCR - ISO 13485:2003 CMDCAS audit ISO 13485:2016 - Medical Device Quality Management Systems 1
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 3
P Registrar Cancelled ISO 13485 Auditors multiple times? Registrars and Notified Bodies 1
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 1
FuzzyD ISO 13485:2016 Customer Assessment OFI ISO 13485:2016 - Medical Device Quality Management Systems 2
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 7
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
ISO-tired ISO 13485: file structure overview ISO 13485:2016 - Medical Device Quality Management Systems 11
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
S ISO 13485 signing of Procedures etc. ISO 13485:2016 - Medical Device Quality Management Systems 10
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2
M Can veterinary implants be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 23
D Audit Report details when ISO 13485:2016 and cGMP 21 CFR 820 are applicable ISO 13485:2016 - Medical Device Quality Management Systems 6
R Looking for ISO 13485 Internal Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 8
FuzzyD ISO 13485 change in process ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom