Validation of Software - NIOSH product (Class II - N95 Respirators)

[ChrissieO]

Could someone please explain what type of software this refers to.

We are not 13485 certified but we are doing some outer packaging/labelling and distribution work for one of our own manufacturing plants, of NIOSH product (Class II - N95 Respirators).

I am trying to find gaps in our QMS (9001:2008) and any requirements of 13485 relevant only to the work we are carrying out.

Clause 7.5.2.1 requires the validation of software. What type of software does this refer to. The only software we use in the process is an in house process management system, a prysm labelling system and after completion the product goes into our warehouse management system for stock control/FIFO and shipping management.

Could someone clarify this for me.

Thanks

Cx

 

[Marc]

Can anyone here help with this? My Thanks in advance!

 

[yodon]

I suspect that this hasn't received a reply because it's a difficult call. What we do is assess the risk to quality on the software and then determine if validation is necessary. Note: risk could be to product or service (did the customer get what was ordered).

An FMEA is a good tool to help assess risk. Consider ways the software can fail and determine what the impact would be. Balance the risk with things in place to mitigate the risk (e.g., if each label printed by the prysm system is scanned or verified, then the risk may be mitigated already). If there's a potential to impact quality, then a validation is probably in order. Scale the validation to the level of risk.

Systems built in house versus commercial products tend to be regarded as needing more validation (the thought being that commercial systems are being beat on pretty well throughout industry and defects would be well known - I don't know that I would agree with the conclusion but...).

Without knowing your systems better, I could make an argument that each one of the systems you mention could be candidates for validation. A good approach to take is to do a little research on Validation Master Plans and establish one for your company. That would provide the guidance for what systems you validate (or provide the rationale as to why you believed you did not need to validate).

Finally, at a minimum, be sure these systems are under good configuration control. Even if you don't do any validation testing, that's a good business practice.

Sorry this isn't much more specific help but it's a pretty broad subject with lots of variables and unknowns.

 

[mogluk]

so just to clarify the systems:

you have an ERP or MRP software system;

a prysm labelling system

process management system.

each one of those would have a different impact on the product if it were to "Fail".

to me the prysm system is the one I would focus on for validation. The others although they 'may' require validation I would say their impact on product quality is less than labelling. (but that's my opinion.)

I would look at your URS for the labelling system, what does it do for your devices and look at a possible retroactive validation, a fault analysis to determine the extent of validation. Maybe the most important, it sounds OTS so, it might have some validation performed already......