I think the key here is to remember that it is on the user responsability to see and adapt the products to perform in the needed validated environment
never pass over that responsabilty to the vendor
I fully back this statement. However, many chromatographers are unfamiliar with IT terms, computer system validation and so on and use their system as a 'black box' as supplied from the vendor.
the user have to decide how to make the CDS function correctly based upon a well defined URS.
Writing a "well defined URS" is a special and highly sophisticated art. Users usually want a system that
a) is easy to use
b) fast and efficient
c) compliant to 21CFR Part11 and all sorts of regulations
d) good field support
Nothing more and nothing less. Non of these points is specific and traceble.
Many people in this forum think e.g. chemstation is a easy to use software. As long as you think in files this is true. Also many big pharma companies use Chemstation, so it must be efficient and compliant.
To be more specific, one could even add the macro-capability to the URS to be more flexible, even though many of us think, macros are just an excuse for poorly designed software.
From my point of view a database based CDS is much easier to operate. However, do I need MS SQL, Oracle, MySQL? As a chemist I can't even tell the difference. Picasa and iTunes are also database based and can be installed without an engineering degree!
Why not use a simple file based system and copy the area values into (validated) excel sheets? Or even in a LIMS that calculates everything?
It also depends on your procedures. Can u change them? In one of labs we used a structured file system with paths like:
$stability protocol\$time point\$climate or
$customer\$product\$date
in an other lab, owing to chemstations and empowers (1) ability to deal with just one folder or project level they created an external database to create analysis numbers for each of the subtasks and labeled the folders or projects with this number.
Without cleanup the number of analysis number folders gets exessive even though there is not so much data.
we as well very much like Dionex because of the dionex support and as well the local rep support that were capable of supplying solutons and information to all our sometimes crazy demands
I like the chromeleon concept because of the connection of a database and a spreadsheet reporting tool with the ability to submit, review and approve each sequence. Many of our stuff don't get the powerful query capabilities (average age much closer to 60 than to 40). However, I like the possibility to view the column history (column S/Ns are entered in a custom colum) and the efforts for each project and employee (projet code entered as custom column). I like the possibility to collect data from validation projects just with a simple query.
If there was some scheduling ability (when do I have run this test) and some workflow capability (which sequences do I have to review), chromeleon could be used as a full-blown LIMS. Nothing impossible with queries, especially as one can the whole thing even without chromatography (e.g. just enter the sample weights and get the distribution, rsd and mean in a report).
Looking for new buisiness models, I think that could be promising. however I really like my job as analytical chemist.
Alex
PS: I just read in a paper that Excel gains more space in buisness calculations, as it it is much easier to 'program' than traditional ERP packages (like SAP).
People just develop Excel sheets (without any controls) to calculate special cases (development, buisness outlooks, special queries...) as doing the whole thing in SAP would require prepare a proposal, get it singned by your boss, get it singed by IT, write a URS, get it programmed, get it validated, get it signed by the IT boss, by your boss, by all other importand people...... get the roll-out.
That would be a chance for Chromeleon, as it combines database capabilities (security, differrnt sign levels....) with ease of use (spreradsheet instead of code progranning).
Maybe I should rethink my creeer desicitions.