Computer System Validation of Bioinformatics Pipeline

sreekiran14

Starting to get Involved
#1
Hi, I need to do Computer System Validation of Bioinformatics Pipeline for 21CFR Part11 compliance and wanted to see if anyone has done that before and details around the process.
I might have further questions to ask but this is just to see if anyone has handled that!

Thank you for your information.
 
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sreekiran14

Starting to get Involved
#3
1. Can we validate an application for Part 11 compliance just with audit trails for electronic records but there is no specific electronic signatures work flow task.system access do have login id and password but none of the tasks have electronic signatures task.
2.This pipeline is configuration of several internet tools that they compile for sequencing analysis, I have no idea how and where to begin. That’s the reason wanted to see if anyone has done that before.

Thanks for the information.
 

yodon

Staff member
Super Moderator
#4
Validation is one thing and Part 11 compliance is another. Yes, you can validate, but, based on the description, it doesn't sound like you could demonstrate compliance.

Where to begin: understand the scope and features of each tool in the sequence.

As far as I know, FDA is still taking the 'enforcement discretion' approach to Part 11. If your software can't be fully compliant with Part 11, you'll want to understand the gaps and determine if this represents a risk (to data integrity, etc.). If so, you may need remedial actions (possibly external to the software). The bottom line is that you need to ensure data integrity at all times. If you don't have sufficient controls to know who entered / changed what, you may have an issue. If you can't clearly demonstrate that signatures are incontrovertible, you may have an issue.
 

sreekiran14

Starting to get Involved
#5
I figured that this is a case of Open system. Would be interested to know what type of controls must be in place for Open system validation.

Thank you for your information.
 

yodon

Staff member
Super Moderator
#6
When using open systems, you have to consider that data / info exposure is a higher risk and put appropriate controls in place; e.g., encryption (both in transit and at rest). Since you don't have complete control over everything, you assume everything is suspect and put appropriate controls in place to best guarantee data integrity, confidentiality, etc.
 
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