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Dear covers,
I am having difficulties in identifying regulatory requirements for validating software that is used in clinical trials.
As a CRO we analyse medical images and calculate some biological parameters using software applications (some internally developed, some from third parties). Pharmaceutical companies typically use our results together with many others during a clinical trial to determine the effectiveness of a drug.
Regarding explicitly to software validation, I believe that 21 CFR 820.70(i) applies to us. Any other regulation (US or EU) we should be aware of?
Are there any Guidance documents for interpretation of the requirements? (e.g. does GAMP 5 applies to us?)
We are trying to draw a line on how deep, which tools and which changes would require which treatment regarding validation, based on the actual requirements and official guidance documents (combined with risk management practices).
Note: I am pretty familiar with the medical device regulations, including the FDA Guidance on the Essential Principles on Software Validation (which technically does not apply to us, although we are using it as a proxy for the moment).
Thank you!
I am having difficulties in identifying regulatory requirements for validating software that is used in clinical trials.
As a CRO we analyse medical images and calculate some biological parameters using software applications (some internally developed, some from third parties). Pharmaceutical companies typically use our results together with many others during a clinical trial to determine the effectiveness of a drug.
Regarding explicitly to software validation, I believe that 21 CFR 820.70(i) applies to us. Any other regulation (US or EU) we should be aware of?
Are there any Guidance documents for interpretation of the requirements? (e.g. does GAMP 5 applies to us?)
We are trying to draw a line on how deep, which tools and which changes would require which treatment regarding validation, based on the actual requirements and official guidance documents (combined with risk management practices).
Note: I am pretty familiar with the medical device regulations, including the FDA Guidance on the Essential Principles on Software Validation (which technically does not apply to us, although we are using it as a proxy for the moment).
Thank you!
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