S/w validation of saved machine configuration settings

[er198]

Can anybody help with the below please? Sorry, there are quite a few questions but i think the question realy is how are configurable settings on machine software opperating applications should be catagorised & controlled?

Scenario:
Considering machines like laser labellers, laser cutters, gluing machines etc that are used in production of medical device’s. Where these machines have software control applications such as CAD software for setting coordinates, voltage, temperature, frequency values etc which are saved to files specific to individual products. Assuming the machines are used on various products (and on different parts of the same product), configuration files must be saved containing settings/values for each cut/glue-point/label. The operator can then select the correct file for the product being worked on.

QU’s
How are these saved files categorised during software validation (operating parameters, electronic data/records etc)? Are there Part 11 implications? If the machine software has no audit trail can new settings be saved by over-writing existing settings? Should changes to settings follow formal change control or is it enough to change & save settings and note values on batch records? If some settings change infrequently after they have been validated, what if there are settings that need to be changed at the beginning of each batch run ie coordinates for cut point due to allowed material variance which could be changed more than once a day - how would these changes be managed? There will be visual inspection at first which will stop when there is confidence in the system. Or is this all detailed in a regulation somewhere?

thanks

[gokeeffe]

@er198

QU’s
How are these saved files categorised during software validation (operating parameters, electronic data/records etc)?

I would category 4 configurable off the shelf software

@er198

Are there Part 11 implications?

Yes as these controls impact GMP data

@er198

If the machine software has no audit trail can new settings be saved by over-writing existing settings?

I would implement a change control system for these parameters and save the old files in an arhive, I would not just over-write and move on.

@er198

Should changes to settings follow formal change control or is it enough to change & save settings and note values on batch records?

As above

@er198

If some settings change infrequently after they have been validated, what if there are settings that need to be changed at the beginning of each batch run ie coordinates for cut point due to allowed material variance which could be changed more than once a day - how would these changes be managed?

Again a change control with a second review to ensure correct paramters are being used.

[quote=er198]
There will be visual inspection at first which will stop when there is confidence in the system. Or is this all detailed in a regulation somewhere?

thanks[/quote]

Not sure I understand this point

[yodon]

@er198

Are there Part 11 implications?

@gokeeffe

Yes as these controls impact GMP data

Graham - not sure I agree with you. What predicate rule is being addressed? I would think the machine would be validated to cover the range of values (parameters) that could be entered, modes of operation, etc. Then, as the original poster points out, the values are noted on the batch record.

For example, if a line is validated to fill a vial with anywhere between 5 and 10ml of fluid (possibly different fluids!) then all this information is just part of normal configuration prior to the run. Batch records indicate the configuration.

Thoughts?

[gokeeffe]

Thanks Yodon,

Good point