Hi Paul I think you will find the numbers don't always add up You have a number of users with different application needs You will always have users with...
Sims, Fraser
fsims@...
Feb 1, 2005 1:18 pm
13126
Risk based is an approach to validation that the FDA prefers. Part 11 Final Guidance - Scope and Application, Sept. 2003: "We recommend that you base your...
Part 11 does not deal with the question of raw data. This is a predicate rule question. What predicate rule(s) are you operating under: GMP, GLP, GCP, or...
There is _only_ risk based validation. If you are not performing any risk assessment then presumably you are either doing too much or not enough. Whichever...
Graham Tinsley
Graham_Tinsley@...
Feb 1, 2005 1:18 pm
13129
Could any one give me a guidance of completing validation plan that would be useful for completing IQ, OQ & PQ of autoclave & Siemen control system? Any...
Although a system may not pose risk to patient or product safety, a system could pose risk to your business. Risk analysis is always a good approach. In any...
From what I can see from your post, you are using your test strip to determine your pass/fail results, correct? Since you never go back to the electronic...
We are reviewing the network qualification that was done quite sometime back. Can someone guide me to the appropriate regulation or quality policy that...
Hello, I work for an early stage drug developer (we are still pre-clinical) and would like some advice from the group regarding archiving raw data. Our IP...
Hepful hint # 1 - make sure your stress medication is up to date. hint # 2 Risk assessment. FEMA type works well but the LIMS users must be involved. Hint # 3...
You can learn more about risk assessment if you do a search on FMEA Failure Mode and Effect Analysis. It is one on the type of RA's that are out there. Amazon...
Hello Hope, The only sure thing is microfilm stored in a salt mine. Tapes and CDs only last a few years. My company has been in the business for 40 years and...
I think after the changes are updated into the Production..we need to maintain a controlled environment for the Production…But still, that company SOPs...
You can search google for some presentation regarding Q9. However, Q9 itself is only at step 1 of the ICH process and not available for public comment. It...
Hi. I just wanted to know if adudits of computer systems with a PLC should be performed. In the case of a PLC used in a labeler, would an audit of the vendor...
There is no regulation per say that says you must qualify your network. If your network is handling data that is impacted by a predicate rule you probably need...
Hi Akash, I would normally agree with Paul. However, in this particular case the Citrix environment is being used to isolate the application from the client....
Hello all, I am new member. Just thought of posting a quick intro. been a validation consultant for 18 months now. New to this field but enjoy every singe...
It sounds like this is more about defending your patents than about FDA matters. The last I knew (5-6 years ago), there was no case law establishing the...
James Christenson
christenson_jim@...
Feb 3, 2005 1:11 pm
13146
I believe you need only go to www.ICH.org and follow the links to the Q list. HTH Vincev ... From: "narcispv" <narcispv@...> To:...
... From: Taylor, Allan [mailto:allan.taylor@...] Sent: Thursday, May 22, 2003 6:51 PM To: '21cfrpart11@yahoogroups.com' Subject: RE: [21cfrpart11]...
Twomey, Suzanne
Suzanne_Twomey@...
Feb 3, 2005 1:12 pm
13148
There is no specific FDA document on network qualification, but networks supporting critical GMP applications are expected to be qualified. There are a couple...
ludwig_huber@...
Feb 3, 2005 3:49 pm
13149
Welcome to the group! An important site to remember is http://www.innovatum.com/sp11.php They have a search tool that is better than Yahoo's for going through ...
Larry Annex 11 is still the same as it always has been since it was introduced in '91, neither is there any indication of it being changed in the near future. ...
My understanding is that Reg.820 applies only to the medical devices industry. Is this correct or does it also apply to drug manufactuers ? Alternatively, are...
Thanks Greg for the information and others hwo sent a nice email welcoming me into the group. But unfortunately I got laid off from my job today ( didn't know...
Strictly speaking, that is correct. 820 is for medical devices. However, the QS Regs (820) are often used to gain a better understanding of what the FDA is...
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