Multicenter clinical trials sw & p11 basics

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

dear community members,

I’m very new to this topic and I’m struggling a bit to get the basics.

What I’m trying to achieve in general is to determine, whether a specific sw solution has to fulfill the requirements of p11 in order to enable it’s usage by pharmaceutical industry.

The actual software I’m concerned with is a system managing multicentre studies including collection of imaging data and allowing image analysis on collected data. I’m concerned with p11 as the system is intended to be used also by pharmaceutic companies in their drug research/clinical trials management.

I understand the requirements, but I’m struggling to get the broader picture as to on what software under what circumstances it applies and why is that…

It would help me a lot if someone knowledgeable could point me in the right direction or kindly share a bit of knowlegde here.

thanks a lot, yours,
… peter

2

The criteria here is whether your software will ever store data that is the subject of FDA predicate rules.

In other words;

  1. Does your software store data?
  2. Is this data, data that is required by the regulatory authorities, either as for part of a regulatory review or for submission?

If the answer is yes to these questions, then part 11 will apply.

If you can eleborate on what your software is actually doing, then perhaps we could advise further.

Regards

Alex Kennedy
CEO

3

dear alex,

thanks a lot for answering!

the software basically allows for quality control, anonymization and storage of medical imaging data from multiple centers and subsequent uniform access to thus collected data.

a typical envisioned usacase within IND study thus is that a pharmaceutical company wishing to set up a clinical study including gathering of imaging data across multiple centers uses the system to achieve this. the doctors in participating departments use the system gateways to perform quality control and anonymization of data and the data is subsequently uploaded into the system database. the researchers from the company then have access to the data, are able to further control the quality and use it for research.

by my other research I came to conclusion that the system manages data that are part of the case histories being part of the predicate rules, therefore it should follow p11 requirements.

on the other hand the system actually does not allow for significant changes to the data - it is rather acquisition than processing system, therefore it’s hard to imagine any harmful impacts on the study other than loosing the data in case of disaster or eventually privacy protection issues should the anonymization pipeline be faulty.

so much for p11 - I’m still not sure and I’ll highly appreciate community opinions!.

very similar situation arises when concerning the Medical Devices legislation of the FDA - is it actually a medical device? I know I’d find out with 513(g), but then it costs $2k :slight_smile: so any opinions from this experts forum is highly appreciated!

thanks a lot for further advice, yours,
– peter