Hey guys, Say you have a lab instrument that will be inherited from a sister site, so it's not like our procurement dept went out and purchased it based on a...
All, ... Yes. Still a User Requirements Specification. The document lists what the user requires the instrument to do. The URS should be considered more of an...
That is the simplest of all specs. Your requirement reads: we want an instrument for free from within our company. You still need to check and document if you...
I think this is way more common than you would think! I have seen a lot of cases where an equipment is acquired and then call the CSV guys to start the...
There are a number of implications from your approach - especially considering that this forum typically discussed compliance and validation: 1. Implying that...
The first question you need to ask is what are you going to use it for? Will it be for some work that must comply with GxP regulations? If yes, then there must...
Yes, the requirement specifications can be developed in this conditions. It will contain that same information as developed in your normal equipment...
I have seen this done many times. A URS is to describe what YOU intend to use the instrument. I am sure it is for a very different project than what your...
The URS is used to document the end users needs. What in the production process is it required for? What critical parameters does it control/monitor/log? What...
Maybe to start educating in software engineering naming conventions And.... What are the regulatory requirements? What are the safety requirements? What...
Uh oh, looks like someone is looking to start trouble! I'd argue that since we're not in the software development business, our regulatory agency probably...
Thank you everyone for all the feedback... Another question is that would you put requirements that are "nice to have" and "wish for" into the URS. But, these...
For most credit card companies if you forget your password there is an automated way or getting it sent to you. If I have a validated system and I want to be...
Our functional requirement SOP states that requirements are to be categorized as either 'Critical', 'Major' or 'Minor'. The qualification team agrees on the...
They question there strikes me as rather simple. If you end up with a product that does not have all of the "nice to have" and "wish for" into the URS, what do...
As I stated earlier the URS should be written by the end user and they should state their requirements in accordance with the S88 standard. This allows the...
... with a product that does not have all of the "nice to have" and "wish for" into the URS, what do you do? If you have to test/validate based on the URS,...
Then the user may be a genious!!! The reqyirement document contains information from a multi team, not user's only. Orlando Lopez Sent via BlackBerry by AT&T ...
I don't know of any regulation that would render this method non-compliant, however, you have to consider your risk here. Are you inside the firewall and...
First, I'm not totally disagreeing with you Orlando. URS = User Requirements Specification - this is what the user wants as far as functionality and controls....
If we have a system that locks/approves/closes a GMP/Part 11 electronic record by means of an electronic signature, can that record then be unlocked, modified,...
slammed, Short answer is yes but you have to be very, very careful. Were submissions made to regulatory agencies or other organizations who were using the ...
I agree--but "downline impact" would be true even in the "paper" world. Technically if your system allows those changes to be done properly, I don't see an...
I think the connection to GLP is to consider the definition of 'equipment'. Thank you, Paula My opinions are my own and do not necessarily represent those of...
Perhaps, but Part 11 was constructed to address computerized systems without specificity to GLP/GMPs. If the system generates and stores e-records (this...
Why not do a simple hardware IQ against the equipment minimum requirements (consensus of different types if more equipment is used). Carl ... [Non-text...
I think your comment is off a little. Part 11 doesn't create any new regulations, it's supposed to apply to the "Predicate Rule" for which the electronic...
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