Hello again. As always, Tom M's post on security is very instructive. On the other hand, I feel I've been dealt a hand from a different deck (maybe from having...
hi everyone, In general, change control normally involves a problem that's reported, a solution/test plan, execution and closure of the change. But if a...
Akasharya74: Not exactly! In a standard, validated, Pharmaceutical Production Sequence, I would first document the episode as an item in a Deviation Report...
The practice I have seen is that you start the change control when a change in the system will be implemented. If your system is running slow, you log your...
I have been following this group discussions for the last few years and wonder why the ID and passwords still create questions and debates. My comprehension of...
It 'starts' of course, with a backdrop of known and documented hardware and software and SOPs mediating processes. That being said, the problem should be...
How do you feel about hardware? Would you follow your change management process or problem management process if you had to replace a bad power supply on the...
The Zen answer: Change control starts when YOU say change control starts. For us, as with most of the other responses to this question, problems are logged and...
In which document (URS, FS, etc.) is it best to put constraints (i.e., requirements) on cost and schedule? If I recall correctly, the GAMP guide says that they...
I usually consider change control as controlling software. Change control starts when you propose a change to an application. I cannot imagine an application...
typically this information goes in your project management related documents. I include cost information in the charter and scope documents. The schedule...
David, I usually put the schedule constraints in the validation plan it usually something like "to be completed in the second quarter of 2005". As for the...
thanks...regarding changes to a production system, this usually occurs on equipment systems that are in production . For example, a HPLC hardware with...
It seems to me that you are applying the Change Control too early. There should be documentation of an issue once it is recognized, but you aren't trying to...
John, You need to get a better imagination ;-) Small companies may not have the luxury of having a test environment that mimics production. A disaster is, in...
Hello everybody: I would like to know your feedback about the new GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and...
Doug, A validated system REQUIRES a workable Disaster Recovery Plan. If the only plan in place is to consider what to do when the Disaster occurs, the system...
John, Doug is correct. There are many different types of systems that need validation. Some of them don't have and really don't need a disaster recovery...
Dux, Tom
tdux@...
Jun 7, 2005 12:53 pm
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"José R. Martínez (AIQS)" <jramon@...> wrote:Hello everybody: I would like to know your feedback about the new GAMP Good Practice Guide: A Risk-Based...
John, We do in fact have a disaster recovery system. It assumes that our entire infrastructure dies and calls for us to have a truck pull up with a copy of...
Hello everybody! Somebody knows something about the new revision of the part 11 from the FDA. I'm looking, but it seems that it's not yet. It's near? Thanks!...
I will put my head above the parapet At the conference in Edinburgh a speaker said that this document started life as a 2 page concept over a cup of coffee to...
Sims, Fraser
fsims@...
Jun 7, 2005 12:54 pm
13790
Hi Jose I went to the European Launch of this in Edinburgh and I think it is a good and positive guide. It focuses on taking more of a risk-based approach to ...
Fletcher, Debbie
debbie.fletcher@...
Jun 7, 2005 12:55 pm
13791
at the Edinburgh conference it was talked about the draft coming out in November . Fraser ... From: ...
Sims, Fraser
fsims@...
Jun 8, 2005 1:34 pm
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Debbie, I am not sure if you heard the question from the floor, but one speaker said that although they did the risk assessment, they still did full validation...
Sims, Fraser
fsims@...
Jun 8, 2005 1:34 pm
13793
I think that we have used his common sense in front of the different rules and guides: * Q9: Quality Risk Management. March 2005. Step 3 * Premarketing Risk...
At yesterday's (6 June 2005), CHPA meeting in Parsippany. NJ, Joe Famulare remarked that FDA's new Rule on Part 11 was in the works and he expects it to be...
My experience with larger companies, even mutli-national corporations, is similar. They don't have test versions of EVERY FDA-regulated system they own. In...
Doug, Part 11 REQUIRES a disaster recovery plan -- even if that means switching to manual recording. You have to guarantee the data. How can you guarantee...
It is always better to implement database code that incorporates 'Record Lock' on all records within a database. The importance of `Record Lock' is to avoid...
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