Validation before Verification. Why not?

SSchoepel

Involved In Discussions
#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
 
Elsmar Forum Sponsor

John Broomfield

Leader
Super Moderator
#2
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
If you validate before you verify you do not know exactly what you validated.
 
G

Guillaume Prom

#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
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.
 
Thread starter Similar threads Forum Replies Date
G Process Validation Before/After Sterilization? Design and Development of Products and Processes 3
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
B Transport Validation For Non-sterile Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
D Software Validation Question ISO 13485:2016 - Medical Device Quality Management Systems 10
G Pad Printing Validation OR Verification ISO 13485:2016 - Medical Device Quality Management Systems 4
A ETHYLENE OXIDE STERILIZATION VALIDATION Manufacturing and Related Processes 4
C. Tejeda Computer system validation approach for Minitab Statistical software Software Quality Assurance 7
D 8.5.1.2 Validation and control of special processes requirements for Heat Treat External Processor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Performance Qualification and Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
L ISO 11607-1 Packaging system validation Design and Development of Products and Processes 6
John C. Abnet ...validation of computer software ISO 13485:2016 - Medical Device Quality Management Systems 14
D Machine rebuilds versus process re-validation IATF 16949 - Automotive Quality Systems Standard 1
R Cloud-based SaMD Validation IEC 62304 - Medical Device Software Life Cycle Processes 8
D Laboratory Refrigerator Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
T SQL Server 2019 - Master Data Services - Validation needed? ISO 13485:2016 - Medical Device Quality Management Systems 4
G Shipping Validation of Non-Sterile Parts? Other Medical Device and Orthopedic Related Topics 9
J Hardware Validation Qualification and Validation (including 21 CFR Part 11) 1
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
blackholequasar Validation of new ERP system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G How to Record Informal Testing (Not Verification/Validation) Other Medical Device and Orthopedic Related Topics 15
B Clean room shut down and re-validation or re-qualification? Other Medical Device Related Standards 6
B Vision system process validation Manufacturing and Related Processes 1
R Validation of Software used in Verification Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
D Glassware cleaning validation Qualification and Validation (including 21 CFR Part 11) 3
M Do i need to have equipment validation if 100% testing is completed? Qualification and Validation (including 21 CFR Part 11) 6
R SaMD Verification & Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
B SPECIAL PROCESS VALIDATION & REVALIDATION Qualification and Validation (including 21 CFR Part 11) 4
R Validation of processes Oil and Gas Industry Standards and Regulations 2
L Guidance for validation - mixing homogeneity Qualification and Validation (including 21 CFR Part 11) 0
E DESIGN VALIDATION, USABILITY AND CLINICAL EVALUATION request Medical Device and FDA Regulations and Standards News 0
S In Field Validation Requirements Other Medical Device Related Standards 1
L Validation of mixers Capability, Accuracy and Stability - Processes, Machines, etc. 2
L Validation of mixers Qualification and Validation (including 21 CFR Part 11) 0
B How to satisfy clause 5.7.1.5 process validation for valve production API 6D Oil and Gas Industry Standards and Regulations 13
A Applying agile model for Computer system Validation Medical Device and FDA Regulations and Standards News 3
H Production Validation- CE Mark ISO 13485:2016 - Medical Device Quality Management Systems 3
Watchcat Software validation vs design V&V? Other US Medical Device Regulations 27
M Initial Importer/Distributor and Software Validation IEC 62304 - Medical Device Software Life Cycle Processes 1
P Test Method Validation (TMV) for all Measurement Methods in Rec/Inspection Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M Validation of Data verification tool per 21 CFR 820 Quality Assurance and Compliance Software Tools and Solutions 1
G Number of Destructively Tested Devices Needed for Ethylene Oxide Validation Other Medical Device Related Standards 4
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
R SAP B1 Computer System Validation Qualification and Validation (including 21 CFR Part 11) 0
A GAGE R&R Binomial with master list (for method validation) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13
N Validation of special processes - thread closed Oil and Gas Industry Standards and Regulations 3
L Validation without Tolerance Qualification and Validation (including 21 CFR Part 11) 0

Similar threads

Top Bottom