Do not read this if
You want to pay three times more for your CDS validation
You want to end up with a high maintenance system.
Or If you want to be hated forever by your boss
I'm sure you do not want any of this, so I’ll make it easy for you to save thousands of dollars for your organization by choosing the right Chromatographic Data System architecture that works best for you.
Throughout the text, I use "CDS" as an acronym for Chromatographic Data Systems.
Chromatography is undoubtedly the most used analytical technique in pharmacopeia USP <621>, BP Appendix III, EP Chapter 2.2.46. Therefore, the Chromatographic data system is the most critical data system in any quality control and research laboratories.
One of the main decisions at the time of selection, installation and upgrading a chromatographic data system is the solution architecture.
Selecting the wrong architecture causes reworks, expansion limits, extensive maintenance, complex validation.
All is about the deployment
Any CDS software has the following components, however the way that these components are deployed and connected to each other makes the whole difference.
Chromatographic System Drivers is a part of application that communicates the control parameters with the Chromatographic equipment (LC, GC, ICS…) and acquires direct data from these systems.
CDS Application is the Main CDS application provides the user interface and necessary functions for security, storage, processing and reporting chromatographic data, which includes database operations.
Database: provides a rational structure to, securely store, update and retrieve generated the data associated metadata.
Here is how it goes
Users operate the CDS application to control the chromatographic equipment and acquire data via the Drivers. The acquired data stores in the database.
User uses the CDS application to access the stored process and generate results and saves the processing parameters and generated results in the database.
All major CDS vendors support the following three main architectural configurations. To make it short and sweet, I exclude cloud deployment and save it for a later article
OOH! Watch out!
The simplest architectural configuration known as stand-alone.
This configuration comprises an acquisition server which is directly connected to chromatographic equipment.
All three CDS components, “Application”, “Drivers”, and “Database” are installed on the acquisition server, which is also used as the client workstation.
Make sure you don't do these...
A common mistake most companies do is, as more chromatographic equipment are added to the navy, they expand the system to multiple Stand-alone configurations.
This basic configuration is easy to set up but is limited to maximum two to three chromatographic equipment and not expandable.
As in stand alone configuration, the acquisition server contains the database, this expansion will result in multiple databases which in turn means application settings and data storage in multiple places.
It makes the system more complex to query, hard to find data integrity breaches, and noticeably increases the system maintenance and validation efforts.
No question, go for it!
If more chromatographic equipment must be eventually connected to the system, the Client/Server, or so-called Enterprise configuration is the best solution.
In this configuration, the database is installed in a separate computer often called Database Server.
Depending on the vendor, a separate instance of the Application might also need to be installed on the database server, to handle some backend functionalities.
It also may contain separate client workstations as extra points of use. Client workstations are personal computers , with the CDS application installed, and linked to the database.
In this configuration the acquired data will temporarily be stored in the Acquisition server, prior to be stored in the database.
Only after the data is securely stored into the database, system will erase the temporary data from the Acquisition server.
If the system experiences any communication problem between the Database and the Acquisition server, it will re-attempt to store the data into the database at a later time.
The Client/ server configuration is easily expandable to support additional chromatographic equipment, by adding new acquisition servers to the system, without having any of disadvantages of the Stand-alone solution.
However, when the number of users increases, more workstations are to be installed and maintained. A partial validation is required every time a new workstation is added or replaced.
Therefore, at a pivot point of about 30 to 40 users, companies may consider adding a Client Virtual Server to the system, which brings us to the next configuration.
CLIENT/SERVER with VIRTUAL-CLIENT
Seems you really have a big lab!
As it shows, this has all the advantages of the Client/ Server configuration, but the virtual-client server provides an environment to populate the application for each user.
users can use any personal computer as a Thin Client connected to the same network, to run the CDS application through the virtual-client Server.
Thin clients do not need to have the CDS application installed therefore no validation is required, instead they will remotely run the application installed on the virtual-client Server.
This will eliminate the limitations that can be introduced by a high number of the users.
There is an additional cost of installation, validation and maintenance of the client-virtual Server, in exchange with the comfort of easy access to the application.
These must be assessed versus the maintenance and validation cost of the numerous workstations in the previous model, to define the pivot point of upgrading to this configuration.
Another factor that makes the decision easier is that the client virtual Server is an environment that can populate other applications like LIMS, and QMS, which is a big advantage for larger organizations.
Making a wise decision for your CDS architecture is a crucial step which deems you control down the road of success.
In hopes that this article has helped you gain clear knowledge on Chromatographic Data Systems deployment architecture, I wish you prosperous results.