Validation before Verification. Why not?

S

SSchoepel

Involved In Discussions
#1
#1
I'm reading 21CFR820, ISO13485, and ISO14969 to clarify for the company the difference between verification and validation.

My question may apply to other medical devices but for a software-only (no hardware at all) medical device, it seems possible, plausible, and defensible to have validation prior to verification.

Alpha software could be tested against use cases and sent to customers to validate the flow/features. Then, the development could finish and all the internal requirements verified. If there were changes in the use cases between the alpha validation version and the final verified version, you could validate just the delta. If there were no changes, no validation.

Has anyone done this and had it pass certification/audit?
Or has everyone just fallen out of their chairs?

Thank you,
S. Schoepel
 
John Broomfield

John Broomfield

Staff member
Super Moderator
#2
#2
SSchoepel said:
I'm reading 21CFR820, ISO13485, and ISO14969 to clarify for the company the difference between verification and validation.

My question may apply to other medical devices but for a software-only (no hardware at all) medical device, it seems possible, plausible, and defensible to have validation prior to verification.

Alpha software could be tested against use cases and sent to customers to validate the flow/features. Then, the development could finish and all the internal requirements verified. If there were changes in the use cases between the alpha validation version and the final verified version, you could validate just the delta. If there were no changes, no validation.

Has anyone done this and had it pass certification/audit?
Or has everyone just fallen out of their chairs?

Thank you,
S. Schoepel
Click to expand...
If you validate before you verify you do not know exactly what you validated.
 
G

Guillaume Prom

#3
#3
verification and validation are defined in ISO9000.

usually for medical device verification is done before validation, in order to verify that the device is safe before using it under real conditions.

"If there were no changes, no validation" it doesn't shock me.. but there is always changes ;-)
 
P

pldey42

#4
#4
In my experience of real time telecom software, verification involves inspections of designs and code against formal requirements, perhaps coupled with module and lab testing, while validation is large scale testing of complete systems, possibly under controlled conditions in the field.

So validation is more expensive; verification can discover defects earlier and more cheaply. Further, verification can discover defects that are hard to impossible to detect with tests - such as memory allocation-de-allocation mismatches - that can have catastrophic consequences for real time systems that must operate 24/7.

Also, validating just deltas could be risky because it can miss defects that have been introduced by the delta: for example, a new feature works but breaks something that previously worked, but, not being noted in the delta, isn't tested again but is in fact broken.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C Design Transfer Review - Before or after PQ validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Q Release of the first batch of a cleared product before process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Requirement for Sterilization Validation completion before issuance of ISO cert ISO 13485:2016 - Medical Device Quality Management Systems 0
Y FDA - Does anyone have conduct the validation on GR&R worksheet before? Qualification and Validation (including 21 CFR Part 11) 7
M Is validation required when consumables are changed Qualification and Validation (including 21 CFR Part 11) 6
C 8.3.4 Verification and Validation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
W Transport validation Qualification and Validation (including 21 CFR Part 11) 12
mustomutlu Process Validation Final Report Other Medical Device and Orthopedic Related Topics 2
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 6
Y SaMD Verification and Validation SOP and Plan IEC 62304 - Medical Device Software Life Cycle Processes 8
C Spreadsheet Validation and Release Qualification and Validation (including 21 CFR Part 11) 2
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
M Sterile packing validation tests to be performed and protocol Other Medical Device and Orthopedic Related Topics 1
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 0
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
C ISO 19227 Validation Cost Other Medical Device Related Standards 2
A CNC Mill and Lathe - Validation Manufacturing and Related Processes 2
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
B Oracle Cloud ERP Validation during Quarterly Patch ISO 13485:2016 - Medical Device Quality Management Systems 1
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
W LTPD, AQL, Ppk and Cpk validation sampling plan table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
J Validation Sample Size for Tray Seal Qualification and Validation (including 21 CFR Part 11) 3
F AS9100 - Validation, FAIR's, ITAR and Sub-Contracting AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R PCBA process validation Qualification and Validation (including 21 CFR Part 11) 2
A ISO 17025 - Methods validation and clients ISO 17025 related Discussions 3
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
B Sterilization Validation Plan Other Medical Device Related Standards 3
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 18
T Laboratory Verification after validation ISO 17025 related Discussions 3
silentmonkey 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 3
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 2
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 4
P Human Factors / Usability validation in the time of COVID Human Factors and Ergonomics in Engineering 17
C Template for Excel Validation Reliability Analysis - Predictions, Testing and Standards 6
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 41
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

Similar threads

Top Bottom