Rapid decisions through instant information availability
Case study: Release of an intermediate
14:30: Sampling of the final intermediate for an API production. The sample was automatically logged by the system according to its batch tree, a bar-coded...
...label was printed at the predefined location.
14:32: Sampling is confirmed by the sampler by reading in the bar-code, thus triggering an E-mail that is sent to quality control. QC initiates preparations.
14:45: Sample arrives in QC lab, receipt is confirmed by reading in the bar-code.
14:46: Sample preparation for HPLC purity determination, 1H-NMR identity and water determination is started. Sample weights are automatically transferred from the balance to the LIMS, sample preparation is documented in the corresponding pre-logged methods.
15:30: Sequences for the CDS and titrator are generated out of the LIMS. Instruments are checked automatically on their calibration status.
15:35: Sequences are started at the assigned instruments. NMR is run.
15:50: NMR raw data are automatically transferred to LIMS where the analyst compares it to reference spectrum. Compliance is confirmed by electronic signature.
16:00: Titration is finished, the titration software evaluates system suitability and the analyst initiates the transfer of the results to LIMS where he signs them off electronically.
17:00: HPLC sequence is finished, the analyst checks the integration and peak assignment and signs-off the data electronically – this triggers the automatic transfer to LIMS.
17:01: LIMS compares all the results with the assigned specifications and concludes everything in-spec. The QC manager receives an SMS telling him to review the data.
17:05: QC manager logs-in from home and reviews raw data in LIMS.
17:15: QC manager signs-off the sample electronically, an e-mail confirming the release with an attached summary report is sent to production and the MES receives the go for the next step.
Case study: FDA inspection
During an inspection by the FDA the inspector requests to see the HPLC raw data for a lot of your drug product produced 3 years ago. Using the lot number...
...and all your confidence you log-in to your LIMS and retrieve all corresponding analytical results within less then 2 minutes. By clicking on the LIMS to CDS button for this specific sample, you directly access the corresponding raw data in the CDS without knowing where the data were generated and where they are stored. The sequence used for the release of the lot pops up on the screen and the FDA inspector - deeply impressed - asks for another coffee.
Case Study: Customer on the phone
Ready to go home, you answer a final phone call. It is your most important customer asking for the status of the analysis of his newest product. Not having a clue...
...you quickly retrieve all samples ran in the last 2 weeks for this customer while chatting with him about local weather conditions. 30 seconds later you have identified the sample and look at the methods logged for it. While clicking through all available results you can tell the customer with all your confidence that only the viscosity measurement is pending and that it is scheduled for tomorrow. More than happy, the customer wishes you a nice evening; you log out and go home.
Case study: Work from home
While enjoying Saturday afternoon with your wife in your garden, you suddenly worry about the 60 sample HPLC-sequence you started on Friday...
...evening. Your boss absolutely needs the results on Monday afternoon for an important meeting. Without telling your wife, you quickly sneak into your house and log-on to the corporate LIMS portal, which gives you access to your CDS and thus all connected instruments. A quick check on your instruments reveals that only the last few samples are pending and that the one currently running looks ok. Relieved, you log out and go back out to your wife, not spending another thought on work for the rest of the weekend.
Case study: Decision by system
While checking the results for the water triple determination for an important intermediate the analyst overlooks that – although the mean value is ok - one determination...
...is out of specification. Upon transfer of the results to LIMS, the system directly highlights the OOS result and informs the lab manager and the analyst about it by e-mail. At the same time, the system automatically logs a basic OOS investigation for this analysis as described in your SOP. This will, upon completion, generate a standard summary OOS report.