Hi Group, We have SOPs on Backup and Recovery, Change Control, Physical Security etc I am writing detailed work instructions for the procedures mentioned in ...
It's been quiet for a few days, let's stir things up with a new thread. Please post if you've been on-site during an FDA audit where the inspector actually...
Been there Chris on four separate occasions in three different companies, as follows: 1. Records requested in relation to radio frequency warehouse. The ...
A. Do not rewrite your software's user manual as an SOP. B. Keep the procedures separate so that when there are changes you don't have to review the whole...
I was involved in a FDA audit related to PMA (for medical device) in July '05. The inspector reviewed the validation package related to our complaints...
Sorry Chris, I forgot to say they were all pharma companies. Dee ... From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of Chris...
In my previous company, we had couple of audits by FDA. In one audit they were asking for version number of the software, we didn't mention the version number...
If I were in your shoes, I would sit by the person who normally does the backup and have him/her explain how he/she does it. After watching the technician...
Two this year, one Pharma, one device. Both inspectors spent some time looking at validation documents, complemented the quality of the work – asked a couple...
If I understand this correctly, it would appear that there are in fact three levels to your documentation: 1) SOP, 2) Work Instructions and 3) Manuals. With...
Kari Habeck
kari_viking@...
Nov 2, 2005 4:40 pm
14527
Hi Dafy: Definitely pays off to have documentation right. Just one general comment and not trying to pinpoint any past, present or future post. I have heard...
Slave, is that why you are moving to Valgenesis, or this is another company? validation_slave <validation_slave@...> wrote:In my previous company, we had...
It was another company. Currently, we have similar situation but more controlled environment. There were few compelling reasons for our implementation. We have...
Juan, Never claim to be perfect! Usually the validation documetation for a given project adds up to several hundred pages usually written under some sort of...
If your company hires a validation firm, is it considered an independent third party? Can they be the independent third party who tests the System? Or is...
On October 21st, 2005 a US District Court judge in Utah dismissed the FDA's case against Utah Medical. Issues before the court: * Issue No. 1(a): Whether Utah...
... independent third party? If you are concerned whether a validation company can truly be independent then you could always go for some organization like the...
FDA will not tell you 'how'. Your validation plan (internal document) should spell out the responsibilities of the persons/groups involved in the process. It...
A validation service provider (VSP, say, for now) that is not a department in your company but a contracted entity would be considered an independent third...
I find this very interesting. It appears that the court is saying that a company is obliged to follow the legally binding regulations, period. "Industry...
I just read Judge Jenkins' entire opinion. It strikes me as being laced with rationality and common sense, as well as a general lament that while both Utah...
When decommissioning old lab equipment that has electronic records, but relies on paper records as GMP evidence, can we delete the electronic record, or are we...
I thought we had started to get control over our systems and applications within my company. We have validated and audit trailed and set up access policies and...
The FDA has stated in its guidance that you have to define your master. It can't be both. From what you say, your paper is the master, thus there is no...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Nov 8, 2005 7:29 pm
14543
I am working for a company in the early stages of developement of a medical administration technology solution and was alerted to 21 CFR 11 by someone who...
The the last 21CFR11 guidance (Aug 2003), FDA made the following distinction: Section B.2., line 185: "Records that are required to be maintained under...
Throughout the life of the equipment, have you defined (in a document signed by the equipment owner, et al) the paper output as the principal record? Has the ...
I could be missing something fundemental about your concern about open source. I would assume you'd still have to go through the same validation protocol for...
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