| Dick,
Having been the support person for FDA previously, I will tell you
that unless things have changed in the last 1.5 years, ORACLE is
the standard database for FDA. However, there are a few groups
inside of FDA which use ACMS/Rdb for their applications. The last
time I spoke to the folks at FDA, there was considerable fighting
about the database.
As for your customer submitting reports and data, I do not know
of any regulation which says the companies must use the same database
as FDA. Afterall, that would mean that all companies which submit
information would have to do that on VAX and either Rdb, Oracle
or RMS, depending on who it is submitted to. I guess you can tell
that I believe this to be a 'bogus' reason for using Oracle.
chuck
|
| > Another thing I heard from this customer that I wanted to follow
> up on, was that a popular LIMS product from Nelson or Perkin Elmer
> was being (or has been) ported to Oracle. Appraently, this product
> is very popular with Pharmaceuticals. Anyone know if there are plans
> to port to Rdb/VMS or if there are competitive products? This customer
> same DEC's LIMS/SM and was not impressed (just reporting).
Nelson Analytical sells a LIMS product based on Oracle (Nelson was
recently purchased by PE). The porting to Oracle is fairly recent;
originally the LIMS was RMS-based. Before coming to Digital I
evaluated the RMS-based product and rejected it due to inflexibility,
among other reasons. This was probably 2-1/2 years ago. Based
at least in part on my input, Nelson delayed shipment of their LIMS
to layer it on a database ... but chose Oracle rather than Rdb.
Why? I never heard. I suspect that Nelson is NOT eager to port
to another database at this time, but you might want to check with
the product manager at Nelson. Way-back-when, this was Ed Long.
Nelson/PE was recently named a SCMP. They also sell laboratory
data collection/analysis software NOT based on Oracle. These integrate
with the LIMS referenced above, but could alternatively talk to
a Rdb database.
Does this help?
|
| As the person in the Laboratory Data Products pmg responsible for
moving more Rdb into the process industries, including pharmaceuticals,
let me see if I can put some perspective on this.
First, Oracle CURRENTLY has the largest market share for strategic
databases in the pharmaceutical industry. A recent survey
(unpublished, and not particularly scientific, but interesting) of the
10 largest pharmaceutical companies in the U.K. showed 9 using Oracle.
The 10th having just recently (since Rdb V3.0 announcment) made a
corporate decision to use Rdb. It's very important that we understand
why. The pharmaceutical industry is very research intensive, and
research tends to use the latest technology. Oracle was very
successful in promoting their relational product to that industry
before anyone else. Now that other products, notably Rdb, are becoming
mature and Oracle is starting to make mistakes, we are becoming more
successful at penetrating pharmaceutical accounts that previously
used only Oracle.
Another effect of Oracle being there first is that there are many
more applications used in the pharmaceutical industry that have
hooks to Oracle. I am working with DBSG to get more research/lab
applications onto Rdb. If anyone has an application that might
be a candidate for this, let me know.
Second, the FDA does use Oracle. However, it is very important
to remember that the FDA cannot, repeat CANNOT, legislate the use
of a particular product. What they can do is ask that the software
that is used be properly validated. The best example of this is
the statistics package SAS. The statistical algorithms used by
SAS were validated by the FDA before any other stat system. After
that, any company submitting a New Drug Application (NDA) to the
FDA had to either validate the statististical algorithms they used,
or use SAS. Needless to say it's easier to just go with the flow,
so 100% of the drug companies use SAS. No database has been validated
in this way, yet.
What the FDA can do, like any federal agency, is require the use
of a particular standard. Thus, they could require ANSI SQL
complience, and then use data manipulation packages that also use
the standard.
As far as what the FDA requires of a database used in the development
or manufacturing of a drug, that is defined by the Good Lab Practices
and/or Good Manufacturing Practices acts (Federal Laws) and the
interpretation of those acts by the FDA. Ultimately, these laws
specify procedures for data management (among other things) to assure
that data is recorded and reported accurately. For a database
management system, there are two critical issues:
1. Audit Trails - These laws specify that all data must be tagged
with the I.D. of the person reponsible for creating the data, and
the date created. Than any change to that data must not overwrite
the original, so that both the original and the modification are
readable, with the changed data 'signed', dated, and flagged with
a reason for the change.
2. Software Validation - This is a new area for the FDA, and there
is much disagreement over what it means. Most of the industry is
promoting black-box testing software, essentially what DTM provides
(in fact DTM is being actively promoted for this).
Oracle does no better than Rdb on auditing. Both packages require
that the audit trail be built as part of the application. An
unidentified future release of Rdb is planned to provide the right
solution for this problem. Call me if you want to talk about it.
Regarding validation, I think we have a lot to talk about relating
the robustness of Rdb versus Oracle.
Regarding specific customers, I would like to talk to Bill (note
.6) and Dick (note .0) about their accounts. I'm probably talking
to the account too.
As far as .7 is concerned - we now have an S/CMP relationship with
PE/Nelson Systems for their Access*LIMS product, which is built
on the Oracle database, written mostly in their 4gl, SQL*Forms.
They have a second LIMS product, LIMS-2000VX, that is being ported
to Oracle from the SEED database. If you are interested in discussing
what PE/Nelson is likely to do in the future, or what LDP is doing
with them, call the relationship manager, Patrick Chassaigne, or
myself. Although it is inappropriate to comment on the contents
of our negotiations with PE/N, or their future plans, in a notes
file, I'll simply say that it is considered highly strategic LDP
and Digtial to have a major LIMS on Rdb. For the record, there are
already two from smaller ISVs:
Encompass from Cheasapeake Software (phone: 302-475-5229) and Astral
and CAST-VAX from Applied Research Labs (phone: 805-295-0019). For more
info see the Laboratory and Science Handbook (EB 32105 61/88).
Regards,
Ed Turkel
Laboratory Applications Marketing, LDP/Science
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