Millennium32 – SQL*LIMS Interface Reduces Data Handling by Over 50%
Millennium32 – SQL*LIMS Interface Reduces Data Handling by Over 50%
The Challenge
A major international pharmaceutical company uses Waters Millennium32 CDS to analyze a large volume of chromatography data.
Sample Set methods were created manually in Millennium32, using worklists from the LIMS. All of the result data was being manually entered into SQL*LIMS, from Applied Biosystems. After the data was entered into the LIMS, it had to be manually reviewed for errors. Another person would then re-check all of the data for errors.
The manual process of creating the Sample Sets, manually entering the data into LIMS and then having to review the entered data was time consuming and costly for the lab. It also slowed down getting results into LIMS, which meant that the end users were not seeing results as soon as they should. Because it was a manual system there was still the risk of incorrect data slipping through the system.
The company realized that automating these manual procedures could reduce the cost of managing their data and improve the turn around time between analyzing a sample and getting the results into their LIMS.
They began looking for an automation solution that would meet the following criteria:
· Automatically retrieve a worklist of samples due for analysis from SQL*LIMS and transfer that into Millennium32 as a completed Sample Set Method.
· Automatically transfer Millennium32 results to SQL*LIMS.
· Meet the security requirements of 21 CFR Part 11.
· Operate in their Citrix environment.
· Be created without custom programming, as they wanted to be able to develop and maintain the interface.
The Solution
IDM-LimsLinkCDS from Applied Biosystems was chosen to create a bi-directional interface between SQL*LIMS® and Waters Millennium32 Chromatography Data System. IDM-LimsLinkCDS was developed through a partnership between Applied Biosystems and Labtronics Inc., the leading developer of LIMS interfacing solutions. In addition to the fact that IDM-LimsLinkCDS met all of their performance criteria, the strong partnerships that Labtronics has with both Applied Biosystems and Waters Corporation gave the company confidence that they had selected the right solution.
Before the final decision was approved, the pharmaceutical company conducted an audit of Labtronics’ software development procedures. Labtronics was designated as an approved vendor and the project was underway.
Initially, Labtronics implemented a pilot project to give the laboratory an opportunity to evaluate the IDM-LimsLinkCDS solution. IDM-LimsLinkCDS was installed on a central Citrix server. Users on the Citrix network would have access to IDM-LimsLinkCDS on the Citrix server from their local PC. This implementation fit into the existing IT infrastructure and reduced the time required for validation as they only had to validate the one IDM-LimsLinkCDS installation. This provided significant savings of time and resources, as validation can be the most time consuming part of a project like this.
A key component in the evaluation was the configurable interface that IDM-LimsLinkCDS provides for interfacing between SQL*LIMS and Millennium32. During the course of the evaluation, it was recognized that using this configurable interface the IT department of the pharmaceutical company would be able to take ownership of designing, creating and validating their own interfaces. They have subsequently developed 5 SQL*LIMS to Millennium32 interfacing methods – one for each type of analysis the labs are doing.
On a daily basis, the analysts select the interfacing method that they want to use for their analysis. IDM-LimsLinkCDS queries SQL*LIMS for a worklist of samples and additional sample information such as sample weight, column ID, etc. The IDM-LimsLinkCDS Expansion Function adds standards and controls to this worklist and creates a Millennium32 Sample Set, without creating any intermediary files.
After the samples have been run, lab personnel use a dual sign off procedure in Millennium32 to show that the results have been reviewed and approved. IDM-LimsLinkCDS retrieves only samples that have been signed off as approved.
Once the samples are retrieved, the labs have chosen to display the results in IDM-LimsLinkCDS. The interface could have been implemented to automatically send the results directly to the LIMS. However, they felt that displaying the samples gives the analyst an opportunity for a final review to confirm that all the samples are ready for reporting to LIMS. Once the final review is complete the results are transferred to SQL*LIMS using ARE.
The Result
By automating their interface between SQL*LIMS and Millennium32, the company calculates that they have reduced the amount of time spent processing their chromatography data by 52%. With a current volume of 500 results per day being transferred through IDM-LimsLinkCDS, this has already produced a significant time saving. Because the process is now automated, these sample results show up in the LIMS as soon as the analyst gives them final approval.
By removing the human factor that is always present in even the most carefully monitored manual systems, they have also eliminated any risk of error in the data transfer process.
Due to the configurable nature of IDM-LimsLinkCDS, they are able to take internal ownership of future interface development and maintenance. They can scale the system up to include all of their labs without having to rely on the vendor.
By using IDM-LimsLinkCDS, the company has met their two goals of reducing the cost of managing their chromatography data while reducing the amount of time between analyzing a sample and getting the results into their LIMS. Over the next year, they plan to implement IDM-LimsLinkCDS in 12 laboratories, representing a total of 300,000 results per year.
Benefits
· They have eliminated manual handling of their chromatography data, saving 15 man-hours per day.
· They have reduced the time required to get sample results into LIMS.
· They have eliminated any risk of manual data entry error.
· They can develop and maintain their own CDS/LIMS interfaces.
…more information about LimsLinkCDS
“Reprinted with permission from Labtronics Connections, March 2004. Labtronics Connections is a monthly email newsletter that provides case studies, articles and application notes related to laboratory instrument interfacing. Published by Labtronics Inc., www.labtronics.com“
