Image acquisition, analysis and processing generates electronic records (21 CFR Part 11)

 

In a regulated or FDA controlled environment, generation of electronic records requires that FDA guidelines are followed. The guidance document can be found at the FDA site but pay specific attention to the language since it is written as a guidance document and is written with non-binding recommendations. You can also download the PDF file from the FDA site

 

This is important since FDA has issued warning letters to some Pharmaceutical companies warning them about compliance. For example it issued a warning letter to Cadila Healthcare informing them that “You are responsible for the accuracy and integrity of the data generated by your firm. Provide a more comprehensive corrective action plan to ensure the integrity of all data used to assess the quality and purity of all drugs manufactured at your facility,including any registration lots”. FDA,Warning Letter to Cadila Healthcare (2011), LINK

 

Usin'Life is aware of the requirements for companies and helps with the training of personnel and guidance as you create electronic records, which would be the images themselves or subsequent analysis files generated from the images. Please pay attention to 21 CFR Part 11 compliance.

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