Sage Line 500 / 1000/ 200 and FDA Compliance

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Sage Line 500 / 1000/ 200 and FDA Compliance

Postby Sam Manager » Tue Jun 23, 2009 3:18 pm

Hi there everyone out in Forum world,

This is my first post on this Forum, so I might as well start with a friendly greeting. I work for a company running SL500, but I guess this question could equally apply to SL1000 or SL200, so experts in those areas please bear with me.

With our next product line, we are likely to attract the attention of the FDA (the US Government Food and Drugs Agency, for those not conversent in TLA-speak). Does anyone have any experience of operating Sage under FDA regulations? If so, please would you be willing to share your insights into what is needed to achieve complience?

Yours (probably with hopefully optimistic anticipation, so don't disappoint me),

Sam
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Re: Sage Line 500 / 1000/ 200 and FDA Compliance

Postby Mark62 » Thu Jul 02, 2009 5:42 pm

As a UK company with a US subsidary ?
It might be worth asking Sage directly or your reseller this question, there is a product called Sage Mas 500 and I was wondering if this was simply Line 500 with a different front-end thats been done for the US market or a different product altogether ...
(not much help i'm afraid) :D
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Re: Sage Line 500 / 1000/ 200 and FDA Compliance

Postby Sam Manager » Thu Jul 09, 2009 3:09 pm

Mark,

Thank you for taking the trouble to reply. It is always good to talk. Yes, we are a UK company with a US subsidiary, but it is both the companys' systems that will need to comply. We talked to Sage first, but I might as well as asked them for a pan-galactic gargle blaster. Blank faces all round. We don't have a reseller to ask, hence why I am trying to contact users directly.

I can't believe we are the first SL500 user to face this problem, but I guess the coincidence of them being FDA compliant AND reading this forum is pretty slim. Still, I'm an optimist, or put it another way, can only be disappointed.

Sam
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Re: Sage Line 500 / 1000/ 200 and FDA Compliance

Postby sagecontractor » Mon Jul 13, 2009 11:57 am

Prior to being GSK, GlaxoWellcome obtained FDA compliance for Tetra CS3 (Sage Line 500). I am not party to the intricacies.
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Re: Sage Line 500 / 1000/ 200 and FDA Compliance

Postby Mark62 » Sat Jul 18, 2009 9:13 am

hmmm I know a few customers with US subsidaries, I can ask around for you, I also work closely with 3 resellers so I can ask them too ... watch this space :D
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Re: Sage Line 500 / 1000/ 200 and FDA Compliance

Postby AnthonyBradburn » Tue Jul 28, 2009 4:07 pm

I've worked on a sub-contract basis for a drug infusion supplier in Basingstoke who were owned by an American Company and their systems were FDA compliant. As with all these accreditations you just simply have to prove you have every angle covered from an integrity point of view so you are both auditable and accountable.

Kind regards

Tony Bradburn
Gold Disk Computers Limited
Website : http://www.golddiskcomputers.co.uk
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