Firstly, determine if it really has to be Part 11 compliant. Secondly, if it needs to be Part 11 compliant (i.e. data is explicitly required to be retained by...
Muchas gracias de nuevo Juan, ahora si no me quedo ni la menor duda al respecto, te comento: Estoy en Guadalajara Jalisco México, laborando para Laboratorios...
Andrew, First Question, Does the system create or store any electronic records required by FDA or other regulations or internal procedures? If not then Part 11...
Marty, I have seen this done in several places- so you are correct it is a common solution to the issue. However, in every instance I have observed serious...
Thanks for the info Rory. It's been hard to get info on this "secret" process. I am unable to attend the conference. Any idea if ISPE is going to make the...
Our organization prepares the final report the first page comprises of signatures of the Investigators involved in the study. We are planning to prepare the...
Would like your thoughts on the level of audit trails used when DBAs access systems that are part 11 compliant, particularly those with oracle dbs. Do you a)...
Juan, The username and password at login do not have to be the same username and password for electronic signatures even if they are the same system. I've yet...
Hi, First of all I will divide Audit Trails in 2 categories... Type-1 : Record / Document level audit trails and Type-2 : System level audit trails e.g. user...
As you mentioned here that you are now moving from paper copies to soft copies(electronic) final reports Then 21 CFR Part 11 recommends that the softcopy /...
From the convestation I understand that all the learned gentlemen are of the opinion that Authorized access to application is a requirement of 21 CFR Part 11...
Hi All: I heard about a Content Management solution called File Bound from Marexgroup. I searched through their web site but could not find a list of clients...
I work with a CRO that has multiple projects. What is the group think about each project having its own set of userids/passwords? My users are complaining that...
I will assume that your records are subject to Part 11... If I understand you correctly, you are applying a handwritten signature to electronic data. The...
We have used a combination a and b approach. Change control to demonstrate Owner awareness and approval of the change and Oracle auditing to capture the audit...
George Smith was also recently at the IVT Validation Conference to which a few of my colleagues attended. It has been relayed to me that the presentation he...
Sabbas, that is precisely what I said, they could be the same or they could be different. In terms of regulation, there is no specific mention just the unique...
Narayan: If the critical manufacturing operation (e.g. Pilot Plant or basic Mfging operation) is in the preparation of an intermediate or Medicinal product...
That is too many userids and passwords. I can understand their frustration. If you do this they will most likely start to use similar passwords, to make it...
I am putting together a Master Validation Plan for our manufacturing plant (we are a component manufacturer). I have the GaMP4 guide that I am using, but was...
Surprised there's been no response to this. At my current company, they roll them out as they come out. The justification is that delaying them is probably...
ask a different question and then do a risk assessment ;-) replace 'validated systems' with 'production systems'. We consider the patch's from microsoft to be...
Hello Everyone; We are nearing the completion of a Part 11 audit and the organization has instituted stringent Technical and SOP changes to acheive compliance....
I agree. or they will just have a postit attached to their monitor with a huge long list of userid/passwords on it. pt 11 only states that you need to uniquely...
The materials from the conference will be posted on the ISPE website, but I'm unclear whether the access is just for the attendees or all ISPE members. Best to...
In a world where some of us are trying to encourage a common sense approach to validation- and believing that the FDA supports such thinking- why would the...
Maybe not the answer, but more a comment. Our system pops up the same message every single time and I still need to find the person who ever reads it.It...
Schmitt, Siegfried (G...
siegfried.schmitt@...
May 3, 2007 1:38 pm
16708
Sorry, which particular predicate rule are you referring to? We manufacture Pharmaceuticals and Devices, there is no requirement in either set of regulations...
thanks greg, so this is a good example with your EDMS system. obviously the patch caused some problems with functionality. so i'm sure people in the...
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