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DSDVB
We are a small startup that is trying to avoid the overhead cost of off-the-shelf QMS software and the validation of any electronic step that would trigger a 21 CFR part 11 requirement.
We are currently exempt under CFR 1271.15(a), but are expanding our business and must soon adhere to the FDA’s Current Good Tissue Practices (sort of a GMP-lite with an emphasis on preventing the introduction, transmission, and spread of disease.)
Now we operate in a mixed environment where some documents are produced and stored on our servers and some documents are printed, filled out and filed. I realize that this would not work as document control in our future cGTP (21 CFR 1271) environment. Therefore we will likely have to take a step back and print out and sign all SOPs, forms etc.
Example Issue. I produce a cGTP-related SOP regarding Environmental Control in MSWord, I, to avoid Part 11, would print and approve the Master Copy and then store that copy for all to see. But what about storing a pdf on the server—perhaps watermarking it “copy” or disallowing printing? This SOP would also have corresponding logs such as temperature, humidity, cleaning, air sampling. Can these be an excel spreadsheet or, in order to avoid Part 11, do I need to print and fill them out manually?
This is one of many scenarios so general guidance is appreciated.
I have read many guidance documents regarding electronic storage, electronic signatures, etc. but very little on how to avoid 21 CFR part 11. Please help!
Cove, thank you for existing!
Danny
We are currently exempt under CFR 1271.15(a), but are expanding our business and must soon adhere to the FDA’s Current Good Tissue Practices (sort of a GMP-lite with an emphasis on preventing the introduction, transmission, and spread of disease.)
Now we operate in a mixed environment where some documents are produced and stored on our servers and some documents are printed, filled out and filed. I realize that this would not work as document control in our future cGTP (21 CFR 1271) environment. Therefore we will likely have to take a step back and print out and sign all SOPs, forms etc.
Example Issue. I produce a cGTP-related SOP regarding Environmental Control in MSWord, I, to avoid Part 11, would print and approve the Master Copy and then store that copy for all to see. But what about storing a pdf on the server—perhaps watermarking it “copy” or disallowing printing? This SOP would also have corresponding logs such as temperature, humidity, cleaning, air sampling. Can these be an excel spreadsheet or, in order to avoid Part 11, do I need to print and fill them out manually?
This is one of many scenarios so general guidance is appreciated.
I have read many guidance documents regarding electronic storage, electronic signatures, etc. but very little on how to avoid 21 CFR part 11. Please help!
Cove, thank you for existing!
Danny