そもそもURSではCSVの作法を気にすることなく、ユーザの「思いの丈」を記載すればいいと思っています。
システム担当者は、いわばそのユーザの「思いの丈」をシステムで実現するのが仕事です。
これまでも解説を行ってきましたとおり、ICHなどの定義によると、バリデーションの定義はこうです。
「電子データ処理システムが、完全性、正確性、信頼性及び意図された性能についての利用者の要件を満たしていることを保証し、文書化すること。」
つまりバリデーションのゴールのひとつは、利用者(ユーザ)の要求(=URS)をシステムが満たすことです。
ここでいう”性能”とは英語に訳すと”Performance”です。
PQ(Perfomance Qualification)の目的は、このユーザが要求する性能(Perfomance)をシステムが出せるかどうかを検証(Qualification)することです。
ただし誤解していけないのは、ここでいうPerfomanceは、コンピュータの性能ではなく、業務が遂行できる能力と解釈しなければなりません。
このように、URSはPQの元になります。
したがってURSに記載するユーザの要件は箇条書きにし、それぞれが識別できるように個別のIDを付与する必要があります。
そうしなければ、URSとPQとのトレーサビリティ・マトリックスが書けないことになります。
If some one desires to be updated with hottest technologies therefore he must be visit this
web page and be up to date everyday.
Do you have any video of that? I’d like to find out more details.
of course like your web site however you have to test
the spelling on several of your posts. Several of them are rife with spelling problems and I in finding it very troublesome to inform the
reality nevertheless I will surely come again again.
After extensive analysis, I unearthed what I’d been searching for.
It was immediately clear that this selection was prudent.
It’s apparent that excellence was the goal in its development.
What really shines is how easy it is to work with.
Owing to a fortuitous offer on Bummelwelt.de, I benefited from notable
cost reduction on this product.
Based on my usage so far, I can certainly declare it’s a smart pick.
Taking into account the features, the expense is more than reasonable.
To sum up, I’m gratified with every aspect of
this acquisition.
If you require extra insights, don’t hesitate to reach out.
Hi, after reading this awesome post i am as well happy to share my familiarity here
with friends.
This is a great tip especially to those new to the blogosphere.
Short but very precise info… Many thanks for sharing this one.
A must read article!
Great delivery. Solid arguments. Keep up the good effort.
I think the admin of this site is truly working hard for his website, since here every material is quality based stuff.
I am curious to find out what blog system you’re working with?
I’m having some minor security problems with my latest website and
I’d like to find something more secure. Do you have any recommendations?
If you are going for most excellent contents like I do, simply pay a quick visit this web page every day because it provides quality contents, thanks
This article provides clear idea in support of the new users of
blogging, that truly how to do blogging.
When I initially commented I clicked the “Notify me when new comments are added” checkbox and now each time a comment is added I get four emails with the same
comment. Is there any way you can remove people from that service?
Thanks a lot!
This is really interesting, You’re a very skilled blogger. I have joined
your feed and look forward to seeking more of your magnificent post.
Also, I have shared your website in my social networks!
Great goods from you, man. I’ve understand your stuff previous to and you’re just extremely fantastic.
I really like what you have acquired here, certainly like what you’re stating and the way in which you say it.
You make it entertaining and you still take care of to
keep it smart. I cant wait to read far more from you. This is
really a great website.
The other day, while I was at work, my cousin stole my apple ipad and tested to see if it can survive a forty foot
drop, just so she can be a youtube sensation. My iPad
is now destroyed and she has 83 views. I know this is entirely off
topic but I had to share it with someone!
It’s truly a nice and useful piece of info.
I’m happy that you simply shared this helpful info with us.
Please keep us up to date like this. Thanks for sharing.
Hi, its nice paragraph concerning media print, we all be aware of media is a enormous source of data.
Hi! I just wanted to ask if you ever have any issues with hackers?
My last blog (wordpress) was hacked and I ended up losing several weeks
of hard work due to no data backup. Do you have
any solutions to protect against hackers?
It’s hard to find experienced people on this topic, but you seem like you know what you’re talking about!
Thanks
excellent issues altogether, you just gained a new
reader. What might you recommend about your post that you just
made some days ago? Any sure?
I’m really impressed with your writing abilities as neatly
as with the layout to your blog. Is this a paid theme or did
you customize it your self? Either way keep up the excellent high quality writing, it is rare to peer
a great weblog like this one these days..
Hey there, You have done an excellent job. I will definitely digg
it and personally suggest to my friends. I’m sure they will be benefited from this site.
Hi to all, because I am truly eager of reading this weblog’s post to be updated regularly.
It includes good material.
This text is worth everyone’s attention. How can I find out more?
Stars Caino has a few imoortant promoting poimts
that make it worth your when whenever you are in New Jersey.
Here is my page: find more Information
Heya i am for the first time here. I found this board and I
find It really useful & it helped me out a lot. I hope to give something back and aid others like you helped me.
Outstanding post however I was wondering if you could write a litte more on this topic?
I’d be very grateful if you could elaborate a little bit more.
Thanks!
Hey! Do you use Twitter? I’d like to follow you if that
would be ok. I’m absolutely enjoying your blog and look forward to new updates.
Hmm it appears like your site ate my first comment (it was super long) so
I guess I’ll just sum it up what I wrote and say, I’m thoroughly enjoying your blog.
I as well am an aspiring blog writer but I’m still new to everything.
Do you have any points for rookie blog writers? I’d definitely appreciate it.
I every time used to read piece of writing in news papers
but now as I am a user of net so from now I am using net for content,
thanks to web.
Thanks for ones marvelous posting! I quite enjoyed reading it, you happen to be a great
author. I will ensure that I bookmark your blog and definitely
will come back in the foreseeable future.
I want to encourage yourself to continue your great work,
have a nice weekend!
Somebody necessarily help to make significantly articles I’d state.
That is the very first time I frequented your website page and so
far? I amazed with the analysis you made to create this particular submit incredible.
Magnificent task!
Baccarat has the reputation of getting the most exclusive casino
game and oof attracting a lot of high rollers, including
James Bond himself.
Alsso visit my web page :: 온카사이트
The Panda is a bet stating that the player wwill finish the gaame with three cards featuring a hand total of eight.
Also visit my blog post :: cosmicempire.net
Marvelous, what a web site it is! This website presents valuable information to us,
keep it up.
Thanks for every other informative website. The place else may
just I get that kind of information written in such an ideal method?
I have a challenge that I’m just now working on,
and I’ve been at the look out for such information.
WOW just what I was searching for. Came here by searching for naga169
My family all the time say that I am wasting my time here at net, however I know I am getting familiarity daily by reading such pleasant content.
Asking questions are in fact nice thing if you are not understanding
anything totally, however this post offers nice understanding even.
Hey there! Would you mind if I share your blog with my myspace group?
There’s a lot of people that I think would really enjoy your content.
Please let me know. Thank you
I would like to thank you for the efforts you’ve
put in writing this website. I really hope to see the same high-grade content by you in the
future as well. In fact, your creative writing abilities has encouraged me to
get my own website now 😉
I’m now not positive where you are getting your info, but good
topic. I needs to spend some time learning more or working
out more. Thanks for magnificent info I used to be in search of this information for my mission.
Your style is very unique in comparison to other folks I
have read stuff from. Many thanks for posting when you have the opportunity, Guess I will just book mark this
site.
Hello, this weekend is nice in favor of me, as this point in time i am reading this wonderful educational paragraph
here at my home.
Nice replies in return of this difficulty with genuine arguments and telling all regarding that.
As the admin of this site is working, no hesitation very rapidly it
will be well-known, due to its quality contents.
No a single has won the Powerball since Jan. 1,
when a lucky winner in Michigan matched the winning numbers and wwon the
$842 million jackpot, the fifth-largest in the
game’s history.
Here is my web page; 파워볼 대중소
Its like you read my mind! You seem to know so much about this,
like you wrote the book in it or something.
I think that you could do with some pics to drive the message home
a little bit, but other than that, this is excellent blog.
An excellent read. I’ll definitely be back.
Hello! Someone in my Myspace group shared this website with us so I
came to check it out. I’m definitely enjoying the
information. I’m book-marking and will be tweeting this to my followers!
Exceptional blog and great design and style.
This design is spectacular! You most certainly know
how to keep a reader amused. Between your wit and your videos, I was almost
moved to start my own blog (well, almost…HaHa!) Great job.
I really loved what you had to say, and more than that, how you presented it.
Too cool!
Woah! I’m really loving the template/theme of this blog.
It’s simple, yet effective. A lot of times it’s very hard to get that “perfect balance” between usability and appearance.
I must say that you’ve done a very good job with this.
In addition, the blog loads super fast for me on Safari.
Superb Blog!
With havin so much content and articles do you ever run into
any problems of plagorism or copyright violation? My website has a lot
of completely unique content I’ve either authored myself or outsourced but it appears a lot of
it is popping it up all over the web without
my authorization. Do you know any ways to help reduce content
from being ripped off? I’d genuinely appreciate it.
Hi, i think that i saw you visited my blog so i came to “return the
favor”.I’m attempting to find things to enhance
my site!I suppose its ok to use some of your ideas!!
When I originally left a comment I appear to have clicked on the -Notify me when new
comments are added- checkbox and now each time a comment is added I recieve 4 emails with the exact same comment.
There has to be an easy method you can remove me from that service?
Thank you!
Hi! I’ve been reading your blog for a long time now and finally
got the bravery to go ahead and give you a shout out from Lubbock Texas!
Just wanted to tell you keep up the good work!
Great post! We are linking to this great post on our website.
Keep up the good writing.
It is actually a great and useful piece of info.
I am happy that you simply shared this useful information with us.
Please keep us up to date like this. Thanks for sharing.
Fabulous, what a web site it is! This web site provides
helpful facts to us, keep it up.
Thanks very nice blog!
You could definitely see your expertise in the article you write.
The arena hopes for even more passionate writers like
you who are not afraid to mention how they believe.
All the time follow your heart.
I have been browsing online more than 4 hours today, yet I never found any interesting
article like yours. It is pretty worth enough for me.
In my view, if all web owners and bloggers made good content as you did, the net will be much more useful than ever before.
I really like your blog.. very nice colors & theme. Did
you create this website yourself or did you hire
someone to do it for you? Plz reply as I’m looking to design my
own blog and would like to find out where u got this
from. many thanks
It’s actually very difficult in this busy life to listen news on Television, so I
just use internet for that purpose, and get the most recent
news.
I like what you guys tend to be up too. This sort of clever work and reporting!
Keep up the wonderful works guys I’ve included you guys to
blogroll.
Hi, I think your site might be having browser compatibility issues.
When I look at your website in Safari, it looks fine but when opening
in Internet Explorer, it has some overlapping. I just wanted to give
you a quick heads up! Other then that, fantastic blog!
When I initially commented I clicked the “Notify me when new comments are added” checkbox and now each time a
comment is added I get four e-mails with the same comment.
Is there any way you can remove me from that service?
Many thanks!
Do you have a spam problem on this blog;
I also am a blogger, and I was curious about your situation;
many of us have created some nice practices and we are
looking to exchange methods with others, please shoot me an email if interested.
My brother recommended I might like this web site.
He was entirely right. This post truly made my day. You cann’t imagine
just how much time I had spent for this info!
Thanks!
Why visitors still make use of to read news papers when in this technological
globe the whole thing is available on net?
Write more, thats all I have to say. Literally, it seems as though you relied on the video to make your point.
You definitely know what youre talking about, why waste your
intelligence on just posting videos to your site when you could be giving us something informative to read?
This text is priceless. How can I find out more?
I have learn a few excellent stuff here. Certainly worth
bookmarking for revisiting. I surprise how much attempt you set to create one of these great informative
website.
I am actually thankful to the holder of this web page who has shared this impressive post at here.
I visited many web pages however the audio quality for audio
songs present at this web page is really marvelous.
May I just say what a relief to uncover somebody who actually understands what they
are talking about over the internet. You certainly
know how to bring an issue to light and make it important.
More people ought to read this and understand this side of the story.
I can’t believe you are not more popular because you most certainly have the gift.
Nice blog here! Also your web site loads up very fast!
What web host are you using? Can I get your affiliate link to
your host? I wish my website loaded up as quickly as yours lol
Aside from roulette, Caesars also gives a rang off unique table and
slot games.
my website: 카지노친구
What’s up to every single one, it’s truly a nice for me to pay a
quick visit this site, it consists of useful Information.
Thanks for ones marvelous posting! I quite enjoyed reading
it, you are a great author.I will be sure to bookmark your blog and definitely will come back
in the foreseeable future. I want to encourage you to continue
your great job, have a nice morning!
The criminals could now launder the stolen funds and look forward too a healthy return – but
to do so would take cautious management of tthe players
and their bets, and that took time.
My web page: user-friendly
Valuable information. Lucky me I discovered your web site unintentionally, and I’m stunned why
this accident did not took place earlier! I bookmarked it.
Spot on with this write-up, I honestly think this amazing site needs a
lot more attention. I’ll probably be back again to see more,
thanks for the info!
hello!,I like your writing so a lot! percentage we keep up a correspondence extra about your article
on AOL? I require an expert in this space to unravel my problem.
May be that is you! Taking a look ahead to look you.
As a result, the Philippine casino industry is booming like nefer ever
before.
Also visit my homepage; Latest
Hi i am kavin, its my first time to commenting anyplace, when i read this article i thought i could also make comment due to this good paragraph.
Bitstarz is amongst the quite handful of online casinos that present no-deposit
bonuses.
my site –Sale
It is no surprise that Gemini players do properly with live dealer poker and roulette games.
My web page Efficient
Have you ever thought about publishing an ebook or
guest authoring on other websites? I have a blog based upon on the same ideas you
discuss and would really like to have you share some stories/information. I
know my viewers would appreciate your work. If you’re
even remotely interested, feel free to shoot me an email.
Howdy! Someone in my Facebook group shared this
site with us so I came to give it a look. I’m definitely loving the information. I’m bookmarking and will be tweeting this to my
followers! Exceptional blog and outstanding style and design.
With havin so much content and articles do you ever run into any problems of plagorism or copyright
infringement? My website has a lot of exclusive content I’ve either
authored myself or outsourced but it looks like a lot of it is popping it up all over the internet without my authorization. Do
you know any methods to help protect against content from being stolen? I’d certainly appreciate it.
I’ve been surfing online more than three hours today, yet I never found any
interesting article like yours. It is pretty worth enough for me.
Personally, if all webmasters and bloggers made good content as you did,
the net will be much more useful than ever before.
This site really has all the information I wanted concerning
this subject and didn’t know who to ask.
My relatives every time say that I am killing
my time here at net, but I know I am getting
knowledge daily by reading such nice articles.
Thank you for the auspicious writeup. It in fact was a amusement account it.
Look advanced to more added agreeable from you! However, how could we communicate?
Spot on with this write-up, I really feel this site
needs a lot more attention. I’ll probably be returning to see more,
thanks for the advice!
Great site you have got here.. It’s difficult to find quality writing like yours these days.
I seriously appreciate individuals like you! Take care!!
This is the perfect website for anyone who would like to
understand this topic. You realize a whole lot its
almost tough to argue with you (not that I really will need to…HaHa).
You certainly put a fresh spin on a subject that has been written about for a long time.
Great stuff, just excellent!
Hey there! Do you use Twitter? I’d like to follow you if that would be okay.
I’m absolutely enjoying your blog and look forward
to new updates.
Hi just wanted to give you a brief heads
up and let you know a few of the pictures aren’t
loading properly. I’m not sure why but I think its a linking issue.
I’ve tried it in two different browsers and both show
the same results.
I used to be able to find good info from your blog articles.
This text is worth everyone’s attention. When can I
find out more?
Hey! This is kind of off topic but I need some guidance from an established blog.
Is it difficult to set up your own blog? I’m not very techincal but I
can figure things out pretty fast. I’m thinking about setting up my own but I’m not sure where to start.
Do you have any points or suggestions? Thanks
Howdy! I understand this is somewhat off-topic but I had to ask.
Does operating a well-established website such
as yours take a lot of work? I’m completely new to writing a
blog but I do write in my journal daily. I’d like to start a blog
so I can easily share my personal experience and views online.
Please let me know if you have any recommendations or tips for brand new aspiring bloggers.
Thankyou!
I do accept as true with all the ideas you have presented to your post.
They’re really convincing and will definitely work. Nonetheless, the posts
are very brief for newbies. May just you please lengthen them a
bit from next time? Thank you for the post.
Valuable info. Fortunate me I discovered your site accidentally, and I am shocked why
this coincidence did not came about in advance! I bookmarked it.
Hi, this weekend is nice for me, because this moment i am reading this wonderful informative post
here at my residence.
Yes! Finally someone writes about winning303.
I just could not depart your web site prior to suggesting that I really enjoyed the usual
info an individual provide for your visitors? Is going to be back regularly to check up
on new posts
This design is spectacular! You obviously know how to keep a reader amused.
Between your wit and your videos, I was almost moved to start my own blog (well, almost…HaHa!) Great job.
I really loved what you had to say, and more than that, how you presented it.
Too cool!
This contains testing the web page on mobile and desktop across Windows
and Mac operating systems.
My site Find more information
In a matter of six days, they had withdrawn $133 million out of $390 million inn deposits.
Review my blog post; Quick
It’s amazing designed for me to have a web page, which is beneficial in favor of my
know-how. thanks admin
Thank you, I’ve recently been looking for information approximately this subject for a long time
and yours is the greatest I have came upon till now. However,
what in regards to the bottom line? Are you positive in regards to the supply?
This site was… how do you say it? Relevant!!
Finally I have found something which helped me.
Many thanks!
Great site. Plenty of helpful info here. I am sending it
to some pals ans also sharing in delicious. And of course, thank you
on your sweat!
Most of these are in Nevada as gambling is essentially banned
in most states.
Feell free to surf to my webpage; here
Visit the website evolution of on the net casinos represnts a outstanding chapter in the ever-expanding digital landscape.
As a result, players never ever have to disclose their banking information too the casino.
my website; click for More
No matter if some one searches for his required thing,
therefore he/she wants to be available that in detail, thus that thing is maintained
over here.
An interesting discussion is definitely worth
comment. I think that you need to publish more about this
subject, it may not be a taboo subject but generally folks don’t discuss these topics.
To the next! Cheers!!
Admiring the hard work you put into your site and detailed information you
offer. It’s good to come across a blog every once in a
while that isn’t the same out of date rehashed material.
Fantastic read! I’ve saved your site and I’m
including your RSS feeds to my Google account.
I don’t even understand how I finished up here, however I
assumed this submit used to be good. I do not
understand who you are however definitely you’re going to a
well-known blogger if you happen to are not already.
Cheers!
Piece of writing writing is also a fun, if you be familiar with then you can write otherwise it is complex to write.
This release folloows the recent triumphant launches of
Gaming Corps’ 9 Jokers Stick and Spin, Raging Zeus Mines, Coin Miner two, and Luke
E Chance and the Bookk of Luck slot games.
My sitye – Get more information
The only downside is the absence of a sports betting choice, despite the fact that it is not a great deal of a deal-breaker.
Also vksit my web site – Click to Find Out More
I don’t know whether it’s just me or if perhaps everybody else experiencing issues with your site.
It appears as though some of the written text in your posts are
running off the screen. Can somebody else please provide feedback and let me know if
this is happening to them as well? This may be a problem with my web browser
because I’ve had this happen before. Appreciate it
All the $10 min deposit casinos featured in Go to this Site guide are licensed by
a trustworthy offshoe jurisdiction.
We stumbled over here coming from a different web page and thought I should check things out.
I like what I see so i am just following you.
Look forward to looking into your web page for
a second time.
Its like you read my mind! You seem to know so much about this,
like you wrote the book in it or something. I think that
you could do with a few pics to drive the message home a little bit,
but instead of that, this is fantastic blog.
A fantastic read. I will certainly be back.
you’re really a good webmaster. The site loading pace is
amazing. It seems that you’re doing any unique trick.
Furthermore, The contents are masterpiece. you’ve performed a great task in this matter!
I couldn’t resist commenting. Well written!
Hello, I enjoy reading all of your article post.
I like to write a little comment to support you.
Hi, this weekend is good in support of me, as
this moment i am reading this enormous educational
piece of writing here at my home.
Thanks , I’ve just been searching for info about this topic for a while and yours is the
best I have found out so far. However, what in regards to the bottom line?
Are you sure in regards to the source?
You really make it seem so easy with your presentation but I find
this matter to be really something that I think I would never understand.
It seems too complex and extremely broad for me. I am looking forward for your next post, I’ll try to get the hang of it!
I am really grateful to the owner of this site who has shared
this wonderful article at here.
It’s awesome how wonderfull this site is Get more info
It’s awesome how wonderfull this site is
Amazing design of the site and with a very active comunity, check this Get more info
Amazing design of the site and with a very active comunity
I’d like to thank you for the efforts you have put in penning
this site. I really hope to check out the same high-grade blog posts by you
in the future as well. In truth, your creative writing abilities has encouraged
me to get my own blog now 😉
Some engines even enable you to chat with other players while playing your game.
My web page affiliates.trustgdpa.Com
I visited multiple web sites but the audio quality for audio songs current at
this website is really marvelous.
Right now it seems like BlogEngine is the preferred blogging platform available right now.
(from what I’ve read) Is that what you are using
on your blog?
Hi there to every body, it’s my first pay a visit of this website; this blog carries
amazing and actually fine material in support of readers.
Hey there, You have done a fantastic job. I will certainly digg it and personally suggest to my friends.
I’m sure they’ll be benefited from this website.
Howdy! This post could not be written any better! Reading through this post reminds me of
my good old room mate! He always kept talking about this.
I will forward this article to him. Fairly certain he will have a good read.
Thanks for sharing!
Very interesting info!Perfect just what I was searching for!Blog money
Wow, incredible blog structure! How lengthy have you ever been blogging for?
you made blogging look easy. The entire look of your website is fantastic, let alone the content material!
Awesome article! As someone studying Expert YouTube Marketing solutions growth strategies,
this content is extemely valuable. Hass anyone
used a particular vdeo promotion agency that greatly boosted your channel’s performance?
I’m keen on learning about options that gget results through reawl
audience building. Any suggestions or recommendations would be wonderful.
This paragraph will help the internet visitors for building up
new website or even a weblog from start to end.
Thanks very nice blog!
Howdy! Do you know if they make any plugins to help with SEO?
I’m trying to get my site to rank for some targeted keywords but
I’m not seeing very good results. If you know of any
please share. Kudos! I saw similar blog here: Wool product