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Re: FDA Validation a Threat to Free/OSS?
by Brian Gorbe on Thursday April 18, @01:05PM
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| I have been involved for years with software validation under FDA regulations. I have just a few observations:
1. FDA's primary concern is patient safety. When it comes to software, devices, drugs, whatever, they will evaluate the risk to safety in determining how much testing, control, and validation is required.
2. In classifying software (or anything else) as a medical device, patient contact is not required. Bloodbank software (i.e., tracking donors and blood types) is classified as devices by FDA and such software must be registered with FDA. The issue is safety. Corrupted bloodbank records could result in someone receiving the wrong blood type.
3. The end-user is ALWAYS responsible for validating the SYSTEM as it is used. A software vendor cannot claim that their software is "validated" and relieve the end-user of that responsibility. A vendor cannot test all applications of their product on all possible hardware using all possible operating systems. So it is up to the end-user to validate the software on their hardware with their OS in the manner they will use the software (e.g., if they will not use a certain feature, they do no have to validate that feature). The end-user can contract out the actual work, as long as the end-user takes responsibility for the work (i.e., reviews and approves protocols, reports, etc.). Please note that the end-user may be an institution, department, or specific person.
4. FDA considers software validation to encompass the entire development life cycle. Requirement documents, design documents, commented source code, and test documents are all part of the validation package. The more of these documents the developers/vendors can supply the end-user, the easier it is to validate and the happier FDA will be.
5. In the 1980's there was contention between FDA, industry (primarily drug manufacturers), and vendors over the availability and inspection of source code. FDA backed off (who could compel Microsoft to release the source code to Excel?). Open source software has the advantage of meeting FDA's concerns and relieving industry of various NDA and escrow entaglements. |
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