COTS (commercial off-the-shelf) Validation FDA Requirements

#1
Hello All,

This question may have been asked before but I couldn't find appropriate answer.If any Commercial off the shelf application is being used in a FDA regulated industry, can we leverage the testing performed by the vendor? If not why do we need to do additional testing at the site if the vendor has already tested the software functionality?
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Re: COTS software validation

Because he has not tested your use of the software. But depending on what he did, you can use any testing as part of your validation testing.
 

yodon

Staff member
Super Moderator
#3
Re: COTS software validation

Marcelo is right, of course, but let me add on a bit.

The software was not tested for your use (as Marcelo points out) NOR was it tested in your environment. I don't know if it's your case, but a lot of software has security features which you have to tailor for your needs, back-end databases which are user-provided, custom forms / routing, etc. These can only be assessed on your installation in your environment.

And one additional point: you should assess the list of known issues to determine if any might impact your operations.

So while you may be able to leverage a lot of the testing the vendor did (presuming you can establish equivalence) you will still probably need to take some efforts to complete validation.
 
#4
Re: COTS software validation

Thank you Marcelo and Yodon for your quick responses. I am sorry that I haven't got a chance to reply until today. The COTS application I was asking is image analysis software which is used to measure thickness and porosity of samples. This software also has the capability to be configured by using VB script. But I am not sure at this point if that is the case at my company. So I already checked with the vendor and they told me that they would not be able to provide their validation documentation. Also it isn't that the software used at my company was never validated. In fact it was validated here as part of the process without much focus on the software (which includes microscope calibration along with basic software testing ex: Intended use was tested). We also have a procedure here on how to measure the thickness and porosity. Now I want to make sure that adequate testing was performed in the past validation. I have the following questions:

Would it suffice if we can prove that work flow written in the procedure was tested?

Further, the software may have a lot of functionality and my company may not be using all of it. So I am thinking to gather the list of only areas/functionality (through user manual) used at my company and verify that they were tested in the past validation. Any thoughts?
 

c.mitch

Quite Involved in Discussions
#5
Hi Sara,
The validation of the vendor won't be useful (perhaps food for thought if you had it).
The validation of software is a classical IQ OQ PQ.
IQ is verifying installation and configuration (the VB script may be seen as part if the configuration),
OQ is verifying sw functionalities one by one,
PQ is verifying sw with real use scenarios.
OQ sometimes is done on a testing platform, different from the target platform used for PQ.

Testing the workflow in your procedure sounds more like PQ.

Before PQ you need an OQ. To do so write a Software Requirement Specification document (many templates are on the internet) containing the functions you use of the software and probably the custom features of the VB script. So when you're thinking of gathering only the functions used at your company and test them, you're right.

Btw, don't forget in you SRS to write the functions used by technicians who maintain the software (eg: backup/restore, calibration ...).

In terms of documentation, you'll have at minimum a SRS, IQ/OQ/PQ protocols and IQ/OQ/PQ reports. One very important thing is to record in your reports which version of software you tested (consequence: the VB script should probably be version controlled).

Bye.
 
Thread starter Similar threads Forum Replies Date
P Qualifying commercial off the shelf (COTS) external suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R Control of COTS (Commercial Off The Shelf) Specifications ISO 13485:2016 - Medical Device Quality Management Systems 2
L COTS (Commercial Off-The-Shelf) Parts with AS9102 FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
N COTS (commercial off-the-shelf) Computers - Warranty return rate? Benchmarking 3
A Packaging Commercial off-the-shelf (COTS) Products as a Single System Design and Development of Products and Processes 2
A Process for receiving functions - COTS (commercial off the shelf) vs Custom parts. Document Control Systems, Procedures, Forms and Templates 6
S Validation of COTS Equipment plus Software Qualification and Validation (including 21 CFR Part 11) 12
Q Buy American Act - COTS confusion Manufacturing and Related Processes 7
M Conformal Coating & AS9102 - Is conformal coating material a COTS part AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
B AS9102 COTS Form 1 vs. 2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
E AS9102 FAI - What makes a COTS modified? (PCB assemblies) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
C Risk Analysis for COTS/OTS Risk Management Principles and Generic Guidelines 4
R Re-validating revised Medical Device and Aerospace Product COTS software ISO 13485:2016 - Medical Device Quality Management Systems 2
S Not accepting Flowdowns for COTS Items AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
K COTS Validation: Should we validate Windows after each Update? IEC 62304 - Medical Device Software Life Cycle Processes 3
K Method to qualify COTS Suppliers into AVL (Approved Vendor List) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R Only Commissioning Software? COTS, GAMP Category 3 Software Validation Requirements IEC 62304 - Medical Device Software Life Cycle Processes 7
A AS9102 for Electronic Circuit Card Assembly that contains COTS Components AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
V Approach towards defining/documenting Requirements COTS vs. New-Product Software Quality Assurance 1
A Commerical off the shelf items (COTS) in DFMEA's (Design FMEAs) FMEA and Control Plans 5
P Commercial excel templates that calculate overhead, hourly rates, fee proposal Excel .xls Spreadsheet Templates and Tools 0
DMLqms Country of Origin on Commercial Invoices EU Medical Device Regulations 2
P Medical Device not on commercial distribution but installed in the establishment. 510k? Other US Medical Device Regulations 10
DuncanGibbons To what extent are NASA standards applicable to commercial aviation? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
B IATF 16949 Cl. 4.3.2 - CSR vs Commercial Agreements IATF 16949 - Automotive Quality Systems Standard 8
shimonv Creating a new commercial product based on a modification to an existing product Other US Medical Device Regulations 4
Ajit Basrur How do I label this commercial product ready for clinical study? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P Design exclusion in AS9100D for commercial products AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
P What is expected in a Medical Device Commercial Release Procedure Design and Development of Products and Processes 3
F Definition Commercial Distribution - Definition - Scope of Commercial Distribution Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
M Commercial tablet as an "accessory" for a medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
E Commercial Laboratory Audit Tips ISO 13485:2016 - Medical Device Quality Management Systems 2
C Commercial Grade Supplier Surveys - Not qualifed 10CFR50 Appendix B or NQA-1 Other ISO and International Standards and European Regulations 2
S ISO 15189 - When commercial QC Material is not available Hospitals, Clinics & other Health Care Providers 4
B Commercial Calibration Laboratory Software Recommendations Calibration and Metrology Software and Hardware 1
T ISO 17025 - 4.1.5b Internal/External commercial, financial, and other pressures ISO 17025 related Discussions 3
B List of all Auto Parts in a Commercial Vehicle Manufacturing and Related Processes 11
C Apostille of French Commercial Documents for the Republic of Turkey EU Medical Device Regulations 5
H Certification of a large commercial helicopter acc. AC29-2C / CS29 EASA and JAA Aviation Standards and Requirements 1
V Common Root Cause for Failures in Scaleup & Commercial (Validation) Batches 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Regulatory Value of Commercial Documents (Brochures, Marketing Leaflets, etc.) EU Medical Device Regulations 2
M Everything to AS9100 vs. ISO 9001? Commercial Jobs require AS9100 "Extras"? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Regulatory requirements for Commercial Medical Devices for sale in Europe ISO 13485:2016 - Medical Device Quality Management Systems 2
B Ideas on how to differentiate jobs (AS9100 jobs vs. "commercial" jobs) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Jim Wynne "Massive" Epsilon Interactive Commercial Email Breach After Work and Weekend Discussion Topics 7
B Commercial Grade Dedication requirements for a 10CFR50 Appendix B Manufacturer Various Other Specifications, Standards, and related Requirements 8
S Risk Management in terms of Technical and Commercial Failure (Disaster Recovery) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Commercial Measurement of Raw Materials/Production etc. Manufacturing and Related Processes 2
B References for GMP Consultants in Illinois (trade/commercial printer/packaging) Quality Manager and Management Related Issues 3
Pancho Oquma - a new QMS-on-wiki commercial offering Imported Legacy Blogs 3

Similar threads

Top Bottom