A PLC in its simplest form contains a program that tells a machine what to do. It doesn't contain the information if the machine did what it was told to do....
PLC = Programmable Logic Controller This type of device is like a computer, with many similarities except it is designed for severe conditions(dust, moisture...
In addition to Part 11, and old FDA CPG covers this case on which a computer "control a specific parameter in the manufacturing of drugs or other processes." ...
Saludos Aka, The part 11 definitions include more than records to be maintained maintained in e-format. There are 5 or 6 conditions in which part 11 is...
"It doesn't contain the information if the machine did what it was told to do"....validation????? Instead of "durable media;" "transiant records:' and so on,...
I have recently worked on some CNC machines used for med device prototype production where the PLC was controlled via an integrated PC (hard drive and...
SCADA's, and other supervisory control systems, should be Part11 compliant. Your system appears to be similar. Margaret ... [Non-text portions of this message...
Assuming a typical SCADA system, without the implementation of the e-signature, then this is a Hybrid Computer Systems. The 21 CFR Part 211 and/or Part 11...
If the prototype devices are not used in clinical trials or put on the market there is no need at all for compliance with Part 11. The missing validation work...
Good point Siegfried. I know that the parts being made are for hospital beds and helps to clamp a device to the bed. The CNC client claims he needs to be...
Hi James It looks like your question got hijacked by a SCADA discussion. In my experience with PID controllers there is no storage onto durable media nor any...
Hi Gram, Are you asking about the graphics package used to layout the artwork or the actual printers, digital or otherwise. Most shops use a commercial...
Hello Smitha Like Deirdre adviced , try to get into some kind of training programme inhouse. Most things depends on your client and the business approach ... ...
I assume the software created print is applied via inkjet or laser printer to the packages as they are produced. Such software has to be compliant as the...
SB You are right. It is immaterial if manufacture is outsourced or not, the exactly same regulations and standards apply. It is the contract givers ...
With respects to 21 CFR part 11 compliance: Is it necessary that Electronic signatures are displayed in the same or similar fashion as the handwritten...
In this scenario it would be a 3rd party application that would link the buyer's and supplier's ERP solution through a common interface. This 3rd party...
I'm thinking Part 11 wouldn't apply...here's my thought stream (tear it apart as you see fit!): There's a whole slew of requirements in 21cfr211 for labels;...
I have seen this addressed by the commonly employed UserID/password combination signature by attaching a Signature Page to the document, stating that the...
No, it is not necessary. The regulation required a signature manifestation (21 CFR 11.50) in certain areas. I believe it is the date and time of signing...
A flaw in your reasoning as I see it is the following: As you intend to sell the labelled medicine you will not be in possession of the record to prove it was...
The error, as I see it, is that this record is not electronic. ;-) Bob _____ From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf...
Jeff: I've been involved in several discussions about this item over the years. First - 21 CRF Part 11 states what needs to be displayed for an electronic...
Graham, I've been struggling over this one for a few days, as I could go either way. I think it's less important to focus on the question of an electronic ...
Thank you for the useful suggestions. To rephrase my question a little more precisely would be: Do we need to leave in the signature table (Author, reviewed...
What's the best way to write requirements for an RFP. In one regard, I don't want to give vendors too much specificity for the project because it's hush hush....
Hi Jeff, We use Master Control for e-signing and documents workflow. For our controlled documents, the signature block is removed from the document, but...
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