Juan, Check out these sites for info on media durability. http://www.audioholics.com/techtips/specsformats/CDDVDlongevity.php Dude. ... the ... retention ... ...
You can get microfiche with an expected lifetime of 500 years. One of the well known companies sells this based on accelerated stability studies. An ISPE SIG...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Jul 1, 2005 3:43 pm
13883
I'll be interested to see what gets posted on this topic for a 100 yr. retention period.... At the rate computer system technology changes, NOTHING is ...
Juan, I know exactly what you are going through. I just went through the same thing. Here is what we came up with internally to address the issues of storage...
Migrating data can be a real headache if you don't stay on top of it. I was involved in migrating lab files from an old Apple PC to windows. The first time we...
Dude, thanks for the link. Siegfried, thanks for the update on microfiche longevity. Another purpose of going with scanning is the hability to do search o the...
Yes. Every company I've worked for has "archives" that no one knows how to read anymore.... As Juan says--have to do something. But I don't think there's any...
Juan, We purchased a fairly high-end Panasonic scanner. It scans about 40 pages per minute and does not do color (The color one is almost twice as expensive),...
Hello all. I have been a part of this group for several years now (in various guises - cfrpart11, hurleyp and more recently just paul.), and during that time...
Laura, The IVT will have the annual ComputerSystem Validation Conference in San Francisco in August. They also have sessions on Part 11 related topics and on...
ludwig_huber@...
Jul 5, 2005 8:51 pm
13893
Thanks Jay, seems like a feasible solution to me. I agree with you, it is a problem to microfiche and scan documents. I try to provide them with all...
I'm assuming the device could be used for a baby and then the person would have this their whole life. That's very interesting. Besides this group, I think a...
How do I submit my 21 CFR Part 11 Compliance Report? We've created a comprehensive report for submission to the FDA as part of the reg. Is there anything we...
Boo, OK, if I showed you a clear, concise, current, configuration controlled SOP that specified the protocol, and you found ample, extensive, and consistent...
Scott The FDA is not interested in your report unless they ask for it during an inspection. If you do intend to use electronic signatures within the meaning of...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Jul 6, 2005 2:10 pm
13898
Your personal experience, which is a lucky one, does not correlate with industry experience for longevity of storage media or trustworthiness of records. You...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Jul 6, 2005 2:12 pm
13899
Hi Siegfried; Thanks for your help. Much appreciated. -Scott ... From: "Schmitt, Siegfried \(GE Healthcare\)" siegfried.schmitt@... Date: Wed, 6 Jul 2005...
Hello, We have been asked to utilize commissioning concepts and Good Engineering Practices for our development testing. I havent had any exposure to this....
... Bear in mind that music CD's produced for sale don't use the same CD's as you and I buy to use. The pits are actually formed into the cd vs. a dye phase...
Hi Thomas, I really hope you don't take this as being overly antagonistic, I both respect and appreciate the work you have done and continue to do in our...
Thanks Greg. That was one of the better articles I have read on the subject. We do a lot of archiving to CD-Rs so that was a good one to send around for others...
I was wondering if anyone had any news about when GAMP 5 was suppose to be published. I had heard rumors about December 2004 but that obviously did not happen....
Would anybody be willing to share the text of such a letter? Please advise. Thank you. Loreene L Kemperman Research Analyst, API, Inc. lkepmerman@......
Is it suffice to allow self-administered training for SOP's? We are a device company and 820.25(b) reads as follows: (b) Training. Each manufacturer shall...
Debate is good. I don't see anything antagonisitc about it. Most all 483s are issued against a CFR reference. Usually something along the lines of failure to...
Is it suffice to allow self-administered training for SOP's? We are a device company and 820.25(b) reads as follows: (b) Training. Each manufacturer shall...
Typically, when I've worked in places where training is self-administered we ve attached a small quiz (usually 10 questions) which the trainee is required to...
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