Hallo all, does anyone have experience of HPLC system Summit from Dionex. I would like a users comparison prior to commiting to purchasing a new HPLC sytem (low pressure gradient, DAD detector). The another systems which are in consideration are from Shimadzu, Agilent and Varian.

The Dionex Summit a.k.a. Gynkotek is a great system! I've used Gynkotek's low-pressure gradient system with their DAD and autosampler for years without much issue other than normal ware and tare items. The pump is very precise and has very low dwell volumes which is important when running small-bore columns. The DAD is extremely sensitive and rivals variable UV's. Hopefully, you are also looking at the powerful software. That's what makes the whole system work as one.

Hi

I have been evaluating software from 4 vendors in the nast month ie Millenium 4, Cerity for Pharma (agilent beta version), Thermolab system Atlas, and Dionex Summit. I would say that the best from the perspective of compliance issues and capability are Millenium and Cerity. Both are very impressive packages. Summit is very easy to use but will need some improvement on the compliance front. Atlas was a non starter

Hi all - To clarify, Summit is a line of HPLCs. The associated software is called Chromeleon, whose 21 CFR 11 readiness is discussed in considerable detail in a 16-page Technical Note that can be downloaded from http://www.dionex.com/app/tree.taf?asset_id=12451). Given that, is there any detail to support the comment "needs some improvement on the compliance front"?

Hi,

FRom my point of view, and from what I have gathered elsewhere, the Summit system is as capable as many of its competitors. A larger aurosampler capacity would be nice, but you cannot have everything.

You asked for it:
is there any detail to support the comment "needs some improvement on the compliance front"?

Unless things have changed...

When I evaluated the SW, the following items were noted that put the compliance issue in question:

1 – Chromeleon relies heavily on Windows NT security to achieve it’s compliance. The FDA have stated that NT security is not sufficient to be fully compliant with the regulations.

2 – The database is open for modification, you simply load MS Access and edit the Chromeleon database directly.

3- using copy and paste within Access you can create fake sequences which can not be distinguished from real sequences.

4- The audit trail can be turn off ant any time, these changes are not documented.

This is a reply to Anonymous, who mentioned

"The FDA have stated that NT security is not sufficient to be fully compliant with the regulations" Were did you find this FDA statement and who from FDA did this statement.

Thank you in advance

Another Anonymous

Could we please have people stand by their postings and not hide behind anonymous. Thanks

In reply to Anonymous #1 (4 Dec 01 05:34):

Thanks for the additional detail. It seems that you may not be aware of some important points:

1. All chromatography software needs a foundation of protection at the operating system level to prevent a would-be saboteur from damaging or deleting files. However, the operating system is designed to administer access to computers, disks, and files, which doesn't map very conveniently to chromatography lab needs. Chromeleon has its own security system that supplements the operating system security, and provides fine-grained control of access to chromatography-specific operations (such as controlling a specific instrument, manipulating baselines, adding samples to sequences, and electronically signing results).

2. People sometimes misunderstand Chromeleon's database implementation, which lets you choose the database platform that's best for your situation. A single-workstation installation of the software defaults to using an MS Access database format, which does not require any database license fees or adminstrative overhead (you don't even need a copy of MS Access). Clearly, this is not an appropriate database platform for multi-user access or environments that require solid security. For those cases, MS SQL Server or Oracle are recommended, and corresponding database licenses are required.

3. When a secure database platform is used, operators can only access sequences through the application, and no such falsification is possible.

4. Audit trails can be turned on and off only if the security system has not been enabled; or if it has been enabled, only by authorized personnel. (It sounds like you were evaluating an unsecured installation.) If a modification history is turned on or off, it does record the pertinent details about that event.

The above-referenced Technical Note provides a considerable amount of additional detail that should help allay any other concerns or misunderstandings about security or compliance. If it doesn't, please let me know.

To Mr. Schilber,

Thank you for the update, it sounds like things have changed slightly since our evaluation.

To Mr. Crowley

I always stand behind my postings and I like being Anonymous, besides does it really matter?

Signed
Anonymous #1 (4 Dec 01 05:34)