Validation of compiler and IDE - Why, when and how to? - Part 3
By Mitch on Friday, 11 April 2014, 13:27 - Processes - Permalink
Coming back to the discussion about validating compilers and IDE, here are a few more comments I have on this topic.
I had the feedback of some readers who told me that it was perceived as mandatory to validate development tools.
No, this is not what I wanted to say!
Edit June 2016: this article is obsolete, since the introduction in ISO 13485:2016 of requirements in section 4.1.6 on QMS software validation using a risk-based approach.
Regulatory requirement in production process
Regulations require validating software involved in processes, but in a limited scope:
- 21.CFR.820.70 (a) requires monitoring and controlling production processes, and
- 21.CFR.820.70 (i) requires validating automated data processing systems and quality system software,
- FDA guidance: General Principles of Software Validation provides guidance on the validation of automated process equipment and quality system software,
- In Europe, the regulation relies on the ISO 13485 standard, which has section 7.5 about validation of production processes, and their software.
Thus, these regulations and guidances are about production processes, only.
Edit June 2016: No, per ISO 13485:2016.
No regulatory requirement in development process
There's no regulatory requirement either in 21.CFR.820, or Medical Devices European Directive, for example, which tells you to validate software development tools.
There's no normative requirement either in IEC 62304, or more generally in ISO 13485.
Thus, validating tools used in a software development process is not mandatory.
Edit June 2016: Yes, per ISO 13485:2016, using a risk-based approach.
The decision to validate development tools is only based on the conclusions of the risk assessment of the development process.
Edit June 2016: Yes, per ISO 13485:2016, using a risk-based approach.
Comments
Hello
your blog is very interesting for me. I am working as software team manager in a medical device company. Validation of software tools is always a big
discussion.
Can you give me some examples of "automated data processing systems" ? Are for example CUnit, LabView, NI Teststand etc.. automated data processing systems ?
Thanks a lot !
Hello Heiko,
As I said in the article, these automated data processing systems shall be at first used in production processes, not development processes.
If you use Labview and NI Teststand to test printed circuit boards during production, to eliminate non-compliant batches, then this is an automated data processing system used in production and it is in the scope of ISO 13485 section 7.5 or 21 CFR 820.70. Thus you have to validate it to be compliant with regulations.
If you use Labview and NI Teststand to test a prototype at design time, then you are not in the case above. At design time, you are in section 7.3 of ISO or 21 CFR 820.30. And there is no such requirement to validate software tools used for design.
But:
If you product is very critical, for example a pacemaker, and if odds are not null that a failure of a tool used at design may result in a failure of the final product, then you will have to validate the tool.
For example, there is a chance that there are bugs in CUnit. If a unit test passes, instead of being failed, because of a possible bug in Cunit, then a bug could remain not detected by unit tests. In the case of software embedded in a pacemaker, such bug could result in a failure of the final medical device with severe consequences for the patient. Thus, given the severity of hazards generated by remaining bugs in CUnit, this tool should be validated.
Hi-
So if mgmt has decided that we must validate all software development tools (compilers, make, etc), how might I go about convincing them this is not in the regulation? It is a massive expense, and it seems it is all because an auditor once asked if we had validated our compiler.
Thoughts?
Alas, if mgmt wants it, or if an auditor once asked for it, do it as minimal as it can be.
Buy AAMI TIR 36 guidance and do it as they write it in this guidance for compilers. It shouldn't be a massive expense.
But IMHO, this is not a way to validate compilers. It's just a way to make people happy with regulatory requirements.
One last thing, it should be necessary to validate software development tools if they contain records related to regulations. For example, using a tracker tool, like redmine, to manage software requirements and bugs. In this case, yes, it should be validated.
The FDA has in multiple documents and presentations stated that 21 CFR 820.70(i) applies to software tools used during design and development. They have expressed that these tools fall under the "quality system" section. (I think there is a valid argument that the FDA retroactively interpreted this regulation, but they have been consistence on this interpretation at least since the GPSV.) One of the examples from AAMI TIR36:2007 is the validation of a C/C++ Compiler (Annex C, Example 4) where it states the compiler is used to partly automate the quality system process of "Software Implementation".
Based on this, I do not agree with your conclusion that from the FDA regulations "validating tools used in a software development process is not mandatory".
The FDA always requires validation, as does ISO 13485:2016. Based on risk this can be very simple, but there should always be a statement such as "tool XYZ has been determine acceptable for its intended use".
Hi Chip,
Thank you for your comment, it is definitively relevant. This article is three years old and based on my experience since then, I have to agree with you. 21.CFR.870.i is applicable to software development tools. But, with a risk-based approach, I will always discard most of software development tools from validation, excepted bug trackers as said in comment #4.
I consider that the example on compilers in AAMI TIR 36 is a joke. And I'm polite. The fact that software development tools are in the scope of 21.CFR.870.i doesn't change my mind on validation of compilers. It's written there: http://blog.cm-dm.com/post/2014/03/28/validation-of-compiler-and-IDE-Why%2C-when-and-how-to-Part-2
I will never spend a second validating a compiler, even if I'm working on a critical life-sustaining medical device. For such device, I will set a mitigation action to manually review the assembly code. For other devices, I will do nothing.