Hi All,

I believe that both require full verification of the process, but at different times. The FDA definition seems to be requiring full verification of the process by inspection and test, or 100% testing of a process. However taking: inspection ≈ monitoring and test ≈ measurement, we can see the ISO definition is extremely similar, but does not say fully verified. However, ISO also has the statement that, "Validate any process...Including the times when deficiencies become apparent after the product has been delivered". This shows that although a process may not be fully verified before the product is delivered, if it is found to not be fully verified, then validation is needed.

http://www.mastercontrol.com/newsletter/medical_device/process-validation-medical-device-0610.html

-Andrew Nashed

Hi All,

I believe that Both the FDA and ISO have established similar requirements when it comes validation. The FDA requires process validation if the process cannot be fully verified by inspections or test. Some Manufacturers use In-line inspection methods, or visual systems to avoid conducting process validation. Some other manufacturers validate their processes to avoid the costs associated with 100% inspection or when 100% inspection is not feasible.

In my opinion, ISO is providing manufacturers with a less restrictive requirement. ISO is letting the manufacturers decide on their best process verification/validation strategy. If the manufacturer is capable of coming up with an innovative approach to replace full verification, then the manufacturer is not required to validate the process.

- Fady Khalla

Hi Dr. Simon!

The heart of validating a process is ensuring it is installed to specification, while characterized and optimized to be under control and capable of consistently meeting specifications. I believe that both the FDA and ISO still require “full” verification for a process that supposedly did not need validation. While the wording of the requirements differs between FDA and ISO, the intent is the same when it comes to the validation of a product. However, it seems like ISO is less strict when it comes to following the requirements. According to the FDA requirement, if the results cannot be fully verified after following inspection and test, the process must be validated, approved, and documented by those who approved the validation. On the other hand, according to the ISO requireent, validation needs to occur when the resulting output cannot be verified after monitoring or measurement. The company is allowed to come up with the best method of validation, and if they do so, then they do not have to complete a “full” validation.

I agree with the posts above. The ISO standard provides the flexibility needed to accommodate the needs of the companies but still providing the necessary regulation to process output. But from the FDA side, it provides the monitoring through the whole lifecycle of the product to provide a consistent quality. Although they are both similar, they are different in the approach of driving a product into the market.

https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf
http://www.iso9001help.co.uk/752.html

As previously mentioned by the fellow commentators, both the FDA and ISO requires a form of validation for medical devices. That being said, it all depends on the wording, this would make certain aspect of the validation process become more complicated which would require a verification process to go along with it. The validation procedure ensures that the process of the product is made to meet the specs and is optimized for the given application and its outputs can be replicated over and over again. Both FDA and ISO require full verification for a process that does not need validation. The FDA states that if the results are not fully verified after an inspection and test, then the process must be validated, approved and documented. Now with ISO, validation needs to occur when the output of the process cannot be verified after monitoring or measurement. It is up to the company to create the best method of validation that satisfies the requirements of the FDA and ISO. As mentioned prior which i agree, ISO provides an extra room for flexibility for companies to regulate the process output while the FDA it requires the monitoring of the entire lifecycle of the product to ensure it is consistent in terms of quality.

I agree with @asimbana that ISO provides more flexibility with their definition "processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measuring. Whereas the FDA has a stricter definition of "results of a process cannot be fully verified by subsequent inspection and test". As discussed in lecture the word "fully" makes it harder. Although by the language it would be possible to not require validation, FDA and ISO would require full verification. As described in lecture there are problems however because; 1. Verification test may be destructive 2. 100% inspection might be costly and 3. 100% inspection might not pick up the defects for example human error. Overall I believe that it is important and smarter to Validate. As Dr. Simon said, "When in doubt, Validate!"

Validation is the process of making sure that you have objective evidence that user needs and intended uses are met. It is usually done by tests, inspections, and analysis. However, the target of the validation is to make sure the user needs are met in a medical device in both ISO,FDA. A successful validation process would clearly define inputs and user needs to ensure that a product is properly validated.
ISO standards in regulating medical devices is easier and less confusing for medical device industry.Also, ISO regulations revised somehow, to be easier than FDA.