Instrumentation software validation

I work for an instrumentation manufacturer, one of the products in the range has just had software developed for it and one appliaction (of many different industrial applications) is in pharma settings. Some customers who are interested in the new software ask about validation. Please can you tell me what exactly ‘we’ the manufacturer (who obviously developed the software) has to do to validate the software. Many thanks for your advice. KLEE

I think the software is generated by use of formulae. The output or print out that one gets after using the software is a result of formulae - most mathematics and statistics or relationship expressed in symbols. So I think to validate software you calculate the results of the formulae by a calculator, or excel spreadsheet. The results obtained in this long way must match those generated by use of software.

Hi Klee
When an analysis of the end user’s priorities, in procurement priorities, is made the importance of the equipment / programs being validateable ranks at number two out of ten. Second only to delivery; with cost ranking around sixth. This has been true in over 80% of all cases we have been involved with.

For the-would-be purchaser, it gives enormous reassurance to know that regulatory compliant validation protocols and plans are supplied. They are often willing to pay a 15 to 30 percent surcharge for these documents. If a consultant is hired to produce the full suite of validation documents (8/9 documents) considerable costs are involved. However it is the question; is the system / program actually capable of being validated? That makes people hesitate. I doubt (after over twenty years as an auditor) if there is any pharmaceutical company that has not at some time had to abandon new programs or equipment for these reasons.

The FDA have actually stated that 70% of validation problems are directly related to none compliant procurement methods.

Your comments about you having to validate the equipment or program are completely erroneous. The end user has that task; your task is to ensure that your product is validatable. That means in all ways it must be compliant with the applicable directives in cGMP. On our site we carry further details of all these requirements.

Alex Kennedy

Every software that i used in pharma industry needs to be “validation friendly” . i.,e., it should have strict access controls, comply with fda’s guidelines on use of software. It should have something called as audit trail - tracing and recording all activities done by user .

No software can be made 100 % validatio friendly but however much is possible in the time available, the manufacturer should it will make his product more competetive than a non friendly software which may need buyin of patches from market

As far as I know a “manufacturer” cannot “validate” his software . It is the user who has to do it. The manufacturer can “help” the end user.

Apart from making his product very validation friendly, A manufacturer can make a “validation package” which has ready made scripts , like IQ/OQ/PQ customizable for the application/environment and sell it with his product . Users love to have a ready made script . This is easier for manufacturer as he sells the same software everytime whereas the end user has to assign a resource, who first reads / understands the software and then writes a 'not so perfect" test scripts for qualification.

Reference your query regarding validation scope; you will find some answers in our brief and concise validation SOP.

The last time we had it on-line for free used, 8.74k persons downloaded it.

Please click on link and follow instructions:

Allan Jarding

Can you please tell what are Source codes and dead codes and how they impact on the performance of the software?

A source code review should be performed on bespoke software to ensure that the code follows good development practices, so look out for how the code is structured and if it is commented well, so other developers can understand what is going on.

Dead code is code that is still in the program but is no longer used as it has been disabled. Dead code should not have any effect on the performance as long as it has been disabled correctly.

Hope that helps

I just want to know how we can verify the quality management system available at the software vendor. Is there any alternative method to verify other than the vendor audit.

I just want to know how we can verify the quality management system available at the software vendor. Is there any alternative method to verify other than the vendor audit.[/quote]

I’m not sure if there is an alternative method, you could leverage off, other vendor audits that were performed on the company, but then you would have to trust someone’s else’s audit.

It depends what degree of risk you are willing to take on, if the vendor is a big player perhaps you could justify it, but if they are a small software house then I wouldn’t take on a risk like that.