Services

Make the most of your investment in BIOVIA solutions with lab-to-plant process consulting, onsite implementation, expert training and superior support

Application Notes

BIOVIA Management Consulting can speed decision making by providing immediate access to information. BIOVIA solutions can rapidly improve organizational efficiency through time-saving automation, capacity optimization and fast data access.

Batch Production

Imagine a system that manages the quality and administrative aspects of your production with just a few mouse clicks―giving you a comprehensive batch genealogy with a minimum of quality reviews. Tight integration with your ERP, MES or PIMS enables additional efficiency gains and minimum data redundancy.

Stability Study

Let the system organize your stability studies, from bar-coding of samples through management of time-points including resource availability, automatic trending and reporting. The system can also alert you when individual results are out of specification and keep track of the location of your samples.

Scheduled Routine Testing

Do you need to survey your water quality on a regular basis? BIOVIA Management Consulting has solutions for automatic sample planning, generation of sampling plans, checks against alert limits and specifications, trending and statistical analysis of your results.

Complex Calculations

Tired of validating Excel spreadsheets? BIOVIA Management Consulting can help you integrate complex calculations from SSTs to sophisticated statistics in validated environments. Automating such calculations can eliminate errors and reduce review cycles.

FDA Inspection

During an inspection by the FDA, the inspector requests the HPLC raw data for a lot of your drug product produced three years ago. Using the lot number, you log-in to your LIMS and retrieve all corresponding analytical results in less than two 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.

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 run in the last two weeks for this customer while chatting with him about local weather conditions. Thirty 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 full 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.

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 of 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.

Automatic System Monitoring

While checking the results for the water triple determination for an important intermediate, the analyst notes that the mean value is ok but overlooks the fact that one determination is out of specification (OOS). 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 email. At the same time, the system automatically logs a basic OOS investigation for this analysis as described in your SOP. Upon completion, this generates a standard summary OOS report.


Paperless Steps for Release Process of an Intermediate
14:30 Sampling of the final intermediate for 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 reading in the bar-code, thus triggering an email 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; calibration status of instruments is automatically checked.
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 them to reference spectra. 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/she 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 automatic transfer to LIMS.
17:01 LIMS compares all the results with the assigned specifications and determines everything is 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 Manufacturing Execution System receives the go for the next step.

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