Chromatography Forum

Ok, this is just a quick query which I have recently thought of.

I'm currently looking into have all our current company protocols (qualification & validation in particular) converted from pdf to executable pdf forms. Currently we have the protocols saved as pdf, we print out the document each time we require to execute it and manual fill in and sign each item as executed (as you might guess this takes a great deal of time on paperwork alone). I've recently received third party vendor documentation as a pdf form with each item as a drop down menu and a single signature at the end. The document looks alot neater and cleaner than the manual writing of each execution part.

What I'm wondering is there a great deal of validation required around these documents to ensure 1) that the dropdown menus are correct and 2) information entered into the protocol can't be altered i.e. testing criteria?

I know the amount of validation owrk that has to go into validation macro's and even excelspreadsheets and I'm just wondering if the same level of validation is required for this type of protocol?

It's your "burzhuinsky marasmus" and "regulator paranoia" , that is derived from ISO 9001. Which is now (with the destruction of the USSR) came up to us. At every sneeze want their corresponding piece of paper signed by the main boss. And most importantly - all under suspicion of crime. Therefore, all forms and documents a translated in PDF format, to be someone he could not change the intent or by accident. Japs at Fukushima this excessive documentation of all procedures now causes hiccups .

Why you do not start easy shape - so in the first place should pay for everything. Secondly, if work is convenient, what will be doing quality department managers and system programmers?

I've never actually worked under cGMP, so all my experience is indirect (with clients). That said, it should be easier to qualify a pdf than a spreadsheet because there are few, if any, calculations involved. The big concern would be security and an audit trail. Those are both areas where your best resource would probably be your IT people. I know that pdfs can be protected, but I don't know how secure that protection actually is.