Equivalence Studies - Validation Activities for several Identical Pieces of Equipment

C

cuteprettyone

#1
#1
:bigwave:Hi,

I was wondering if anyone has developed an Equivalency procedure used during the execution or maintenance of validation activities for several identical pieces of equipment such as lathes, mills, etc.....

Do you believe if the variances of two identical pieces of equipment are equal or better than a "gold" standard then equivalency testing can be incorporated in validation activities?

:thanx:
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
Bev D

Bev D

Heretical Statistician
Leader
Super Moderator
#2
#2
Re: Equivalence Studies - Validation Activities for several Identical Pieces of Equip

well since your posting in the FDA forum we should first understand that our 'beliefs' have little to do with acceptability to the FDA statisticians. Also, the FDA typically doesn't accept 'equivalence' as statistically we can't ever prove that. We can however demonstrate that no substantially important difference exists. This usually requires large-ish sample sizes. We must incorporate the Beta risk of missing a small difference D (where D is the acceptable difference between the two systems) for determinimg the sample size. Both the average and the variance are important. My organization will utilize matched pairs as often as possible to minimize teh sample size.
 
J

Juan Dude

#3
#3
Re: Equivalence Studies - Validation Activities for several Identical Pieces of Equip

Validation in this case is the tool used to prove with objective evidence your belief that there is no difference between the equipment.

Best of luck.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C Equivalence Studies - Validation Activities for several Identical Pieces of Equipment Manufacturing and Related Processes 1
S Demonstration of equivalence EU Medical Device Regulations 3
R Statistical Methods for comparing test and reference product equivalence for quality attributes US Food and Drug Administration (FDA) 3
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
D Proving Substantial Equivalence in Software Medical Devices Design and Development of Products and Processes 2
R Demonstrate how sufficient levels of access to data is achieved - Claims of equivalence EU Medical Device Regulations 3
TheMightyWife Clinical Evaluation MEDDEV 2.7.1 Rev 4 demonstration of equivalence EU Medical Device Regulations 6
K Substantial Equivalence Predicate Device Testing Other US Medical Device Regulations 1
H Claiming equivalence with the product that was sold earlier in the market but not now EU Medical Device Regulations 1
M Medical Device News FDA News - 14-09-18 - Benefit-Risk Factors to Consider for Substantial Equivalence Other US Medical Device Regulations 0
H Equivalence within Medical Device Family EU Medical Device Regulations 1
G HPLC Method Equivalence between USP and EP Various Other Specifications, Standards, and related Requirements 1
C Technical File Assessment from a NB - Clinical Equivalence CE Marking (Conformité Européene) / CB Scheme 6
K ISO 10993 Requirements For 510k - Substantial Equivalence Other US Medical Device Regulations 11
P FDA - Evaluating Substantial Equivalence in Premarket Notifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
O Equivalence between AEC-Q200 and Product Life Time IATF 16949 - Automotive Quality Systems Standard 1
A Determination of Production Equivalence for Design Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T FDA 510k Submission - Section 012 SE (Substantial Equivalence) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G A question on Substantial Equivalence (SE) ? Other US Medical Device Regulations 1
P Testing a US device in Europe to prove Equivalence in a ?head-to-head? Study EU Medical Device Regulations 6
C Statistical Analysis to Demonstrate Substantial Equivalence to the FDA Other US Medical Device Regulations 5
I Determining Statistical Equivalence - Our Laboratory Results vs. our Suppliers Statistical Analysis Tools, Techniques and SPC 4
J The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Substantial Equivalence for Laser Wavelength - Class 2 Aesthetic Product Various Other Specifications, Standards, and related Requirements 2
S New Equivalence Rules in Mexico for US and Canadian Medical Devices Other Medical Device Regulations World-Wide 9
C Clinical Data to Prove Equivalence Other US Medical Device Regulations 4
M Demonstrating Substantial Equivalence - Requesting 510(k) data from company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
A Process Standard deviations and equivalence of Cp & Cpk Capability, Accuracy and Stability - Processes, Machines, etc. 3
K Clinical Studies of MD and IVD in the US US Food and Drug Administration (FDA) 6
I Hold Time studies for Primary Reference standards Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
K Continue to do clinical evaluation? or transfer to RA? or focus on clinical studies as MA? Career and Occupation Discussions 1
P Worst case HLD sample for efficacy studies Other US Medical Device Regulations 0
A Do clinical performance studies for IVDs need to be conducted in a member state? EU Medical Device Regulations 2
A Do clinical performance studies for IVDs need to be conducted in a member state? CE Marking (Conformité Européene) / CB Scheme 0
M R&R Studies - how many? per product? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
K Initial capability studies on similar parts APQP and PPAP 7
R MSA Studies for chemical analytical instruments in QC Lab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Nonclinical Studies Other US Medical Device Regulations 0
I RWE Studies and Design Controls US Food and Drug Administration (FDA) 1
S MSA clause 7.1.5.1.1 - Statistical studies on counting weight scale Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
M Packaging studies - ISTA vs ASTM CE Marking (Conformité Européene) / CB Scheme 0
R Compatibility studies for Combination Products - Europe Medical Device and FDA Regulations and Standards News 2
R Compatibility studies - combination product CE Marking (Conformité Européene) / CB Scheme 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
V Part selection for R&R studies Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 4
L Proof of Concept Studies - Do we need to comply with SAE reporting? Medical Device and FDA Regulations and Standards News 3
R MSA studies for Heat Treatment Equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
R Revalidation machine line and Stability Studies impact. Medical Device and FDA Regulations and Standards News 3
C Medical Device Shelf life studies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom