Validation of Computer and Network Equipment Test System

Dr.mr555

Starting to get Involved
#1
I am a Quality Manager for a company that imbeds COTS computers, routers, and switches into our products along with designing our own interface CCAs, cables, and enclosures.

Our System Engineers have developed testing methods and scripts that employ the use of other network equipment to stress test our products while gauging data throughput and processor usage percentages while assuring operation is within acceptable temperature limits.

My concern is with validating the test system that?s been created. I would think that COTS components with onboard sensors reporting temperature and processor usage cannot be validated independently because the unit is built, tested, shipped.

I would think other, more permanent equipment, such as routers and switches used to evaluate performance could be calibrated, although I?m not certain of this. I?ll take for granted that the test environment temperature sensor can be verified to a traceable standard.
I have some limited computer hardware experience but have nowhere near the level of expertise that our System Engineers have. Please help guide me through this. Thanks!
 
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
I don't see calibrating networking equipment. There's setup and maybe some tuning (e.g., for load balancing) but I wouldn't consider that calibration. The only "measurements" are what you indicated but that's all software-driven so no calibration.
 

Hershal

Metrologist-Auditor
Trusted Information Resource
#3
Generally the network equipment, whether COTS or specific development, can be verified. The verification can verify the individual items and also the system as a whole.

As for the temperature sensor, yes it can and should be calibrated. The sensor may be calibrated independently and then married up in the system. If the sensor cannot be calibrated separately, then it must be calibrated in situ. To assure that you get traceable calibration, you should employ an accredited cal lab with temperature in the scope.

Hope this helps.
 

Dr.mr555

Starting to get Involved
#4
"Generally the network equipment, whether COTS or specific development, can be verified."

Is there a piece of equipment or test kit that can be used to verify data transfer rates other than software tools?

Thanks!
 

Hershal

Metrologist-Auditor
Trusted Information Resource
#5
Yes, the network analyzer does that. I have not used one in quite awhile, but did use them in the past to verify the function of ATE.
 
Thread starter Similar threads Forum Replies Date
C. Tejeda Computer system validation approach for Minitab Statistical software Software Quality Assurance 9
John C. Abnet ...validation of computer software ISO 13485:2016 - Medical Device Quality Management Systems 14
A Applying agile model for Computer system Validation Medical Device and FDA Regulations and Standards News 3
R SAP B1 Computer System Validation Qualification and Validation (including 21 CFR Part 11) 0
S Computer System Validation of Bioinformatics Pipeline Qualification and Validation (including 21 CFR Part 11) 5
E Computer System Validation - Migrating to SAP Document Control Systems, Procedures, Forms and Templates 5
N 7.5.2.1 Validation of the Application of the Computer Software - PLEASE CLARIFY ISO 13485:2016 - Medical Device Quality Management Systems 9
S Computer Simulation Validation Tests for Underwater Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Medical Device Manufacturer Document Control Computer System Validation Qualification and Validation (including 21 CFR Part 11) 4
somashekar Software Validation vs. Validation of the Application of Computer Software ISO 13485:2016 - Medical Device Quality Management Systems 16
AnaMariaVR2 Computer System Validation Resources for the FDA Regulated Industry Qualification and Validation (including 21 CFR Part 11) 2
B Computer System Validation Records - Document Destroy Date - Animal pharma company Records and Data - Quality, Legal and Other Evidence 3
D Validation of computer controlled tensile testers General Measurement Device and Calibration Topics 0
G Computer software validation system in medical device industry ISO 13485:2016 - Medical Device Quality Management Systems 4
S FDA Validation - Does one have to conduct validation for Computer Servers? Qualification and Validation (including 21 CFR Part 11) 8
C IS0 13485:2003 - Validation of the Application of Computer Software ISO 13485:2016 - Medical Device Quality Management Systems 57
P Validation Methods of Machine learning and Artificial intelligence Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 9
M How to respond to 483 validation finding we disagree with? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 33
I Cryogenic Container Closure Integrity for HCT/P, Validation Method US Food and Drug Administration (FDA) 0
G Mfr. Process Validation BEFORE Design Transfer? Other Medical Device and Orthopedic Related Topics 1
G Injection Molded Parts in Verification & Validation Other Medical Device and Orthopedic Related Topics 3
B Spreadsheet - Used for complaint investigation - Validation required or not ISO 13485:2016 - Medical Device Quality Management Systems 9
T Vacuum Heat Treatment Validation Manufacturing and Related Processes 1
M Root Cause and Corrective Action for CAPA's lacking validation/verification ISO 13485:2016 - Medical Device Quality Management Systems 19
M Software Validation SAP B1 for ERP ISO 13485:2016 - Medical Device Quality Management Systems 2
V Retrospective validation medical devices Qualification and Validation (including 21 CFR Part 11) 7
P Software validation for FPGA Software Quality Assurance 1
I Are suppliers required to hand over process validation reports? ISO 13485:2016 - Medical Device Quality Management Systems 20
N Computerized System Validation ISO 13485:2016 - Medical Device Quality Management Systems 8
M 3D Scanner Software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
E Cybersecurity for Internal Tool Validation Medical Device and FDA Regulations and Standards News 1
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
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 9
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
G Process Validation Before/After Sterilization? Design and Development of Products and Processes 3
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

Similar threads

Top Bottom