All, I encourage you to look at the Able Laboratories 483 items issued in 2005...7 of the 12 items are related to electronic records and hybrid systems. ...
Siegfried, Can you point me to any other references (not already listed for this subject) that elaborates on your point, "medical device validation relies on...
Boy, you guys are just all over the place on this question. Unfortunately no one has asked the fundamental question. At what point in the "Records" life...
Does the FDA still require that they receive a certification "in paper form and signed with a traditional handwritten signature" that a company intends that...
Ned Harris
nharris@...
Feb 2, 2007 6:59 pm
16375
All, That Able Labs link is broken. The link to the re-typed-in .html 483 is: http://www.fda.gov/ora/frequent/483s/07012005_AbleLabs/FDA483_07012005.html The...
David Yes, it was a 483. The wording there is just referring to the unsatisfactory level of validation. The detail was conveyed verbally. The issue is when...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Feb 2, 2007 7:01 pm
16377
Hi Ned, I asked the same thing to Paul Motise a couple of weeks ago, this was his answer: Greetings, Thanks for your message. If your client intends to apply...
Here's what the 2004 draft revision of the FDA guidance, Computerized Systems Used in Clinical Trials, says: As required by 21 CFR 11.100(c), persons using...
Are there any medical device companies out there that have already filed this certification ? Thanks, Ned Harris ________________________________ From:...
Ned Harris
nharris@...
Feb 5, 2007 2:23 pm
16381
GAMP is planning on having a 1 day conference in Washington DC, June 5, 2007 at Marriott Crystal Gateway "GAMP Validation of Automation and Computerized...
Hi Ned, Yes, many companies have sent this letter of notification, I would not be surprised if all large pharma companies have done this.Regards,Sabbas To:...
What scenarios could cause risk to the business like recalls and discontinues production? 1. Being shut down because we are not complying with the law. 2. When...
Hi Can anybody give me some indication if there is a specification or guidelines for the installation of electrical and instrument cables in a clean area?...
Just off the top of my head: 6. Loss of client confidence in your organization. 7. Product performs incorrectly not because it was not tested properly, but...
Has anyone any information about when GAMP 5 is suppose to be issued? I had heard dates ranging from fall 2005 to spring 2006 and yet nothing has been issued. ...
If you do not validate your software, any type of product problem you could imagine could happen if you rely on data from that system. If the data are...
The release date for GAMP 5 was discussed at a recent GAMP Europe Forum and it would still appear to be a little way away. Some mention of mid 2007, but...
A: Insufficient process controls and documentation B: Insufficient training C: Equipment that does not meet the needs of the process because requirements not...
9. Due to poor performance/failure of product, someone is injured = liability, lawsuits, fines, etc. Thank you, Paula N. Wehmeyer Corp. IT Reg. Specialist/Sr....
The pending changes to daylight savings time in the US require patches to server and client OS, and some JAVA libraries. If one assumes that the patches will...
I believe GAMP 5 target is November 2007 December 2006 was the target to get all the drafts available. GAMP Editorial Review Board had several working sessions...
My understanding is that GAMP 5 is supposed to be a reorganization of the book, so it's easier to use as a reference guide. I've heard it will be released this...
Hi, I am looking for any infoprmation the guides specifications for server rooms: ac, subfloors, humidity, sapce, fire supression, etc. Any hints? Thanks...
The timestamp issue is no different than for any other year with the exception that it occurs on a different date. Only systems that synchronize with each...
I believe you are 'underwhelming' this topic. The DST change set to take place on March 11 and again on November 4th; both of which are different than the...
You will find more information at the GAMP IT Infrastructure Control and Compliance, also at ISACA and IVT Network Qualification Guide. But you will not see...
As I reread my response, I sensed that I came off with a little bit of a relaxed tone - that was not intended. I do believe that IT should do everything it can...
There was a great cover article in MIT's TECHNOLOGY REVIEW entitled "Why Software is So Bad" (July 2002) that is a very good (non-pharma) background article if...
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