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Pharma company receives LIMS and ELN solution

VelQuest has integrated LabWare LIMS and the SmartLab GMP ELN at a major multi-national pharmaceutical company for its worldwide quality operations.

The combined solution involves a multi-tiered application infrastructure that includes the VelQuest SmartLab GMP Electronic Notebook System implemented at the local manufacturing sites and handling all test method execution and instrument data capture operations within the QC and analytical development departments.

The ELN is interfaced with a centralised LabWare LIMS system that manages all material testing requests coming from SAP and other sources, tracking the overall sample workflow, as well as managing all stability studies and key reporting activities across the enterprise.

The integration provided several key capabilities:

• LabWare LIMS to SmartLab input – All product testing requirements and pertinent sample information are directly passed from LabWare LIMS to the SmartLab GMP Electronic Notebook System for execution of the method.

• QC lab procedure execution – Test methods are delivered to approved analysts via handheld tablet PCs in a wireless lab environment. Each method step is captured with full metadata documentation direct to the SmartLab database. Test method calculations are integrated into the SmartLab validated procedure manager system.

• QC lab instrument integration – Through the SmartLab instrument integration library, data is captured directly from all analytical instruments and chromatography data system (CDS) along with a 'compliance state check' on the instrument’s calibration status prior to capturing data.

• QA dashboard review process – In the SmartLab ELN, all QC data is approved within a compliance dashboard that electronically reviews the stepwise method and observation QC test data and flags data that does not meet the desired range. The QA review group needs only to work on data elements with a compliance flag. All data can be reviewed at the click of a mouse button including chromatograms, spectra etc. This capability speeds up the data review process by 50-75 per cent.

• Transfer of reviewed results to LabWare LIMS for specification checking, final sign off, and reporting – Once the first level of review has taken place in the SmartLab ELN, all relevant QC test result data is transferred to LabWare LIMS where the results are compared against the product specifications and final sign-off of the results occur by the QA review group. LabWare LIMS provides extensive reporting and trending capabilities to produce certificates of analysis, stability summaries, and product review reports and trend charts.



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