Re: Validation in non-regulated industries/markets

On 11/13/2024 12:59 PM, Don Y wrote:

The effort is usually significant (in Pharma, it begins long before the
product development -- with audits of your firm, its process and procedures,
the qualifications of the personnel tasked with the design/development,
etc.).
 For a specific product, you must verify everything documented
behaves as stated:  show me that you will not accept invalid input;
show me that the mechanism moves to a safe state when configured
(or accessed) improperly; show me that you can vouch for the information
that your sensors CLAIM and the actions that your actuators purport
to affect; etc.  Just stating that a particular error message (or other
response) will be generated isn't proof that it will -- show me HOW you
sense that error condition, how you report it and then give me a real
exemplar to prove that you *can*.

E.g., from an FDA document:
"Qualification of utilities and equipment generally includes the following activities:
• Selecting utilities and equipment construction materials, operating
   principles, and performance characteristics based on whether they are
   appropriate for their specific uses.
• Verifying that utility systems and equipment are built and installed in
   compliance with the design specifications (e.g., built as designed with
   proper materials, capacity, and functions, and properly connected and
   calibrated).
• Verifying that utility systems and equipment operate in accordance with
   the process requirements in all anticipated operating ranges. This should
   include challenging the equipment or system functions while under load
   comparable to that expected during routine production. It should also
   include the performance of interventions, stoppage, and start-up as is
   expected during routine production. Operating ranges should be shown
   capable of being held as long as would be necessary during routine
   production."
Note that this is in addition to validating the *process* to which the
equipment is applied: how do you procure your raw materials, ensure
THEY meet their respective standards, control access to them to prevent
contamination/loss of potency, combine them, store them, distribute them
on the factory floor, assess the performance of the resulting product
E.g. how long for the actives in this product to be present in the
patient's system?  how long for a particular coating to dissolve in
the digestive tract?  WHERE in the digestive track will that occur
(some products are coated to survive the acidic environment in the
stomach for absorption in the intestines)?  etc.

The *customer* ultimately knows how the product will be (ab)used -- even
if he failed to communicate that to the developer at the time the
specification was written (a common problem is the impedance mismatch
between domains:  what the customer takes for granted may not be evident
to the specification developer).  He will hold its feet to the fire
and refuse to accept the device for use in his application.