I'm a medical device systems engineer who's gotten pulled in to regulatory work over the past few years, so I may have some gaps in my knowledge on non-device stuff...
I'm working with a new outfit that's bringing software and a hosted database to market which captures info from a PACS system, makes some calculations, results are reviewed by a doc then stored in the database for use in longitudinal studies. As far as their regulatory needs, they say that customers are asking for 21 CFR 11 compliance, but nothing else involving the FDA. I'm a little puzzled by this, as my understanding has been the 21 CFR 11 only applies to electronic signatures needed to fulfill *other* FDA regulations (a.k.a. predicate rules). Seems odd that anyone would want to *only* adhere to electronic signature regs when what they're signing is (claimed to be) not under FDA's jurisdiction.
This customer's product will likely be used to produce and store data for clinical trials, so at that point I suspect that their customers will want full FDA-level QMS, design controls, verification and so forth. But for now, they believe they only need 21 CFR 11. Does that make sense?
Also, if they claim adherence to 21 CFR 11, will they be implying a level of validation and control of software and tools that complies with FDA regs for their products intended use?
Thanks in advance!
I'm working with a new outfit that's bringing software and a hosted database to market which captures info from a PACS system, makes some calculations, results are reviewed by a doc then stored in the database for use in longitudinal studies. As far as their regulatory needs, they say that customers are asking for 21 CFR 11 compliance, but nothing else involving the FDA. I'm a little puzzled by this, as my understanding has been the 21 CFR 11 only applies to electronic signatures needed to fulfill *other* FDA regulations (a.k.a. predicate rules). Seems odd that anyone would want to *only* adhere to electronic signature regs when what they're signing is (claimed to be) not under FDA's jurisdiction.
This customer's product will likely be used to produce and store data for clinical trials, so at that point I suspect that their customers will want full FDA-level QMS, design controls, verification and so forth. But for now, they believe they only need 21 CFR 11. Does that make sense?
Also, if they claim adherence to 21 CFR 11, will they be implying a level of validation and control of software and tools that complies with FDA regs for their products intended use?
Thanks in advance!