Validation of Computer and Network Equipment Test System

D

Dr.mr555

Starting to get Involved
#1
#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!
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Y

yodon

Staff member
Super Moderator
#2
#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

Hershal

Metrologist-Auditor
Trusted Information Resource
#3
#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.
 
D

Dr.mr555

Starting to get Involved
#4
#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

Hershal

Metrologist-Auditor
Trusted Information Resource
#5
#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.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Applying agile model for Computer system Validation Medical Device and FDA Regulations and Standards News 2
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
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
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) 0
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
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
shimonv Test Method Validation ISO 13485:2016 - Medical Device Quality Management Systems 10
R Debug mode in software/device validation IEC 62304 - Medical Device Software Life Cycle Processes 2
M Software verification and validation AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Melissa Process Validation of Rotary Heat Sealer Speeds Design and Development of Products and Processes 4
C Validation of process for releasing the UDI EU Medical Device Regulations 4
C Validation of process for production and servicing 5.7.1.5 API Spec Q1, 9th Edition Oil and Gas Industry Standards and Regulations 9
W Transport validation Qualification and Validation (including 21 CFR Part 11) 4
M Is validation required when consumables are changed Qualification and Validation (including 21 CFR Part 11) 7
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 1
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

Similar threads

Top Bottom