Do new requirements always need a validation?

N

nikolaos

#1
[FONT=&quot]Hi All,

I googled inside Elsmar to find answer to my question but I did not find anything, so I try to launch this thread that is causing me a big headache [/FONT][FONT=&quot].

My questions are the following:
1. (background) We inserted a new localization on our clinical data management system, a Fareast asian language in particular. This requirement was requested by Marketing so it's part of our User Requirement document:

Is it required to validate (I do not refer to verification, we do verification of the new GUI, in order to avoid cropped text or malfunctioning in data insertion)?

2. In general: is it correct to say that when we introduce a new User Requirement, we need to add validation related to this requirement?

I really thank you in advace for the support you can provide.[/FONT]
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#2
The "validation" may be as simple as checking whether the language is available; so it would be done as part of the verification.
But you can extend the validation to ensure that the text has been properly translated. Translation validation may already be a part of a separate process/procedure.
 

yodon

Staff member
Super Moderator
#3
Agree with mihzago but would like to extend a bit. Translation can be a tricky thing. Native speakers may tend to use colloquialisms that may not be appropriate for a medical device setting / professional. Always good to get the translation validated, IMO.
 
N

nikolaos

#4
Hi yodon and mihzago,

first of all thanks both for your precious answers! They helped me to clarify the topic related to the validation of localization.

Furthermore I would ask you or whoever, about my second question, that is:

is it correct to say that when we introduce a new User Requirement, we need to add validation related to this requirement?

In particular, just to do an example, let?s assume that I insert a new filter for searching data inside a table, input coming from Marketing. This is a new requirement, consequently would you do a validation or not?
I do not refer to verification that should be done in any case.

Just to avoid misunderstanding I quote a definition of Verification and Validation from Wikipedia ?In other words, software verification is ensuring that the product has been built according to the requirements and design specifications, while software validation ensures that the product actually meets the user's needs, and that the specifications were correct in the first place. Software verification ensures that "you built it right". Software validation ensures that "you built the right thing". Software validation confirms that the product, as provided, will fulfill its intended use.?

Thanks again
 

kreid

Involved In Discussions
#5
Hi Nikolaos,

I would say that you could answer your second question using the definitions you found in Wikipedia:

If the new requirement impacts your definition of the what is the "right thing" then you should a validate it. After adding the new requirement you have to demonstrate that you are still building "the right thing".
 

mihzago

Trusted Information Resource
#6
I think you're getting too hanged up on terms and definitions.
What does it mean "to add validation" or "do validation"? Isn't checking whether you have the language enough of a validation? You can specifically check whether the language you translated to is the one that's used in the particular country.
Validation does not have to be some kind of an elaborate process.

Also, in some cases the verification and validation can be the same, especially in software.
 
Thread starter Similar threads Forum Replies Date
P CSR (Customer Specific Requirements) in TS 16949 Audits - Always required? IATF 16949 - Automotive Quality Systems Standard 27
L Change Notification Requirements for class 1 devices Medical Device and FDA Regulations and Standards News 1
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
D What are the acceptance criteria/requirements for Stability Study? General Measurement Device and Calibration Topics 7
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J WAIVED ON Q1 - We Don't have to comply with FORDS customer specific requirements IATF 16949 - Automotive Quality Systems Standard 2
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
Techilady Ford Special Characteristics Communication and Agreement Form (SCCAF) provides production requirements? FMEA and Control Plans 4
P Requirements for being an European Representative EU Medical Device Regulations 3
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
lanley liao How to understand correctly the requirements of API monogram products Oil and Gas Industry Standards and Regulations 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
J SSQR-01 Vision Requirements- Color Blindness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
R Weld Penetration Standards and Requirements Manufacturing and Related Processes 2
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
L Requirements for Cables used for Low-Voltage DC Mains (12-36VDC) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
S Determining the requirements for the products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D LiPo battery minimum requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
V MDSAP Requirements for Device Designer Canada Medical Device Regulations 1
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
S What are the International Forging Requirements for Nitrogen Strengthened Stainless Steel? EU Medical Device Regulations 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
S Distributor requirements in US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
F Environmental Requirements E-Lab General Measurement Device and Calibration Topics 0
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Composites - Freezer sensor requirements Manufacturing and Related Processes 2
A Requirements for Contract Manufacturers Other Medical Device and Orthopedic Related Topics 3
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
M IEC 61010-1 requirements for motors Other Medical Device Related Standards 0
J Requirements for registering Alcohol Wipes (70% IPA) in Canada Medical Device and FDA Regulations and Standards News 4
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
N German National Requirements - Safety Officer/Authorised Rep Other Medical Device Regulations World-Wide 0
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
F USB powered handheld medical device - Isolation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Test requirements for marketing in US when RATED values are not of US IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5

Similar threads

Top Bottom