That is a question that can be answered in a variety of ways. Trying to run a business entails a variety of functions...Accounting, scheduling, and the medical stuff, etc. I guess it depends how savy one is in excel, VBA, etc. Some "canned programs" are better suited for "canned functions"...Once you want to leave the structure of the canned program, it becomes difficult. If you want have some flexibility then write your own book.
Another issue is the data entry...if an inexperienced user is involved, then be prepared to answer some questions.
If it is a matter of collecting clinical data then Excel or Access is best for that.
Just my opinions.
for a new guy please clarify
"Title 21 CFR Part 11"
pll This message was edited by plettieri on 2002-10-20 20:30
It's the FDA guidelines as to what they expect/prohibit/obiligate when you mix computers and medicine.
Mostly they worry about industry. Where I work, boss wanted to take us wireless as to stocking received material. It was promptly shot down, for the time being.
If it looks like a database, smells like a database, and you have critical (clinical tests, maybe?) information on it, then you need to reconsider.
If you search on that phrase, you will find CD-ROMs on validation protocols, seminars on validation protocols, consultants, etc.
Another buzzword is IVT, instrument validation and testing.
FDA is worried about chains of custody, who entered the data, etc. If the program simply prints out, and doesn't save anything (and you can prove it's save mechanism is disabled) perhaps you are okay.
The main grief is who entered the data, and how to prove/disprove.
I am basically ignorant of this stuff. As time goes by, and in-house Regulatory visits the netherworld of Receiving, I will know more.
The nightmare scenario currently making the rounds is Baxter. They 'blew off' the FDA, and finally, the FDA 'shut them down'. All I know is our company is now a bit phobic about new applications that could be interpreted as 'database'.
Another nightmare scenario was the radiation therapy machine that interpreted a technician
s typos without giving an error. I think ten times the expected dosage was given. Yes, people died.
Just be careful when you mix Microsoft Office and anything pharmaceutical.
Thanks for your explaination.
I really did not undertake the question in the same light that you did. The basis for my answer was more directed in the everday user life of trying to perform routine functions and operations of running a business. I haved helped a few others in standard business uses of Excel in a variety of functions. I am sure the medical/clinical profession has its own standards of data acceptance/qualification and the author of the question might be encouraged to obtain these specifics from those experts.
It would be helpful to me, for future reference, to ask a follow up question to Tom F... what details or expected replies you were expecting from your question orginally asked?
Actually, my son-in-law who has approximately a year left before he embarks on his practice as a doctor. He asked me about the feasibility of using Excel to enter patient's data for research purposes. He is not certain exactly the research he wants to conduct at this time but was inquiring of the suitability of Excel.
You asked, "What details or expected replies you were expecting from your question orginally asked?"
Not knowing the potential of Excel, the question was posed to this message board in order to find out the feasibility of utilizing Excel for such purposes as well as Pros and Cons.
The mb members have a vast amount of knowledge regarding Excel capabilities and other areas and would be able to give sound advice.
It is still early as there is a year to go.
I appreciate your input and the input of your colleagues.
Compliance with the FDA's 21 CFR Part 11: ER:ES (http://www.fda.gov/ora/compliance_ref/part11/Default.htm) regulations is something of a thorny issue and something I deal with daily working in the pharmaceutical industry. As it stands Excel is inherently non-compliant and it is very difficult to make it so as it is hard to guarantee the validity of the data to a level required by GxP (though there are some 'wrap-around' COTS applications available e.g. from http://www.wimmersystems.com/). As for Access I have little experience so I couldn't really say anything for or against it. This message was edited by Chris Chattin on 2002-10-22 09:58