Hi Smita, ERP Validation is very big Task. It is integrated with so many modules with so many transactions. Do carefully and complete the task. I am giving...
Hi! I am new to this group, new to the medical device industry, and new to regulations for electronic records and signatures!! I have worked in the ...
We are a growing company and currently have several GLP QA auditors with basic knowledge of computer system validation and computer system validation auditing....
Annette Johnson
ajohnson@...
Jan 2, 2008 1:01 pm
17376
Greg I would also look at the guidance notes that supported the original publication. (Federal register vol 62 No 54 Thursday March 20 1997 which was published...
Sims, Fraser
fsims@...
Jan 2, 2008 1:02 pm
17377
The configuration settings for a Virtual Machine is located in a text file (*.vmx) that can be printed as documented evidence and verified when the VM is...
There is no substitute for experience. If someone claims to know the basics, then they need real world projects and as many as they can get. I would even go as...
Thanks Fraser, I have a copy of the regulation with the Preamble, so I was able to check that. I would agree that it seems like they are suggesting password...
Hi Emily, There are numerous software applications out there that can assist you. If all you need is a system that can be used to manage SOPs, WIs, forms,...
Hello, We are currently looking into changing our Computer Validation Process and I wanted to get some feedback from others. Currently, we have an SOP for CSV...
For our virtual servers, I follow the same rationale as a real server. I meet the requirements of the application that will reside on the "server." Virtual...
Currently I am working within the regulated environment of the pharmaceutical industry and could use some advice on the effort that is needed to successfully...
Greg - it varies considerably; we use at least 15 minute lockout period after no more than five sequential failed attempts, but I have seen a range between 10...
Guida, Richard [JJCUS]
RGuida@...
Jan 10, 2008 12:29 pm
17385
Generally we do a Regulatory Assessment as the first step, before the VMP, and develop a Risk Assesment as part of the VMP or a RAMP (Risk Assessment and...
Angel, Our change control process includes the Scope and Risk Assessment at the Change Request stage. This way we can modify (or even reject) Change Requests...
Could someone define the acceptable environmental /physical conditions that shoudl be addressed when selecting or designing a storage facility for electroinc...
Belated Happy New Year Group !! Can anyone recommend a good Part 11 "add-on" software package that can be incorporated into an existing application to provide...
Emily, Using electronic documents and records has a big advantage in terms of efficiency, but for a small organisation making the change represents a major...
Vickie There is no such thing as "Part 11 functionality". For example, take a computerised systems that is set up with access control. This may satisfy Part...
Dear Maya I suggest you have a look at www.nara.gov and I can recommend the ISPE (www.ispe.org) GAMP Good Practice Guide on Electronic Data Archiving, which...
I always consider access to my bank account as critical and I would consider the complexity of the password as typical, given the millions of people using a...
What is the application?? Kirby From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of vickieprice Sent: Thursday, January 10,...
I think that risk rssesment is something that many people were already doing implicitly on their validations. Many of us were already evaluating how much...
Hi Angel Your thoughts trouble me, if you are going to ignore validation implications prior to, and after, instigating modifications and repairs, then why...
Hi Nathalie: An MS Office upgrade in a validated environment is a pretty drastic software change. To be on the safe side, you should fully validate your...
Alex, I am not sure I explained myself well enough in my original message. First off, our company does pharma recalls, mostly destined for destruction. We do...
Angel, Totally agree with Tom, To be effective the Change Control has to be done up-front. If the change request is not the first step then the changes are not...
We are talking about Microsoft OFFICE right(or did you mean WINDOWS)? I wouldn't do a thing to change to office. Just change. Until the transition is...
Do you really mean Office 2000 (i.e. Word/Excel/PPt/Outlook) and applications written within those environments (Word and Excel docs with macros)?? Did you...
Siegfried I can not follow your logic, when you carry out an IQ for a Part 11 compliant system you verify that there is (off the top of my head just now) ...
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