Laboratory Software for the Pharmaceutical and Biopharmaceutical Industries
Production in the pharmaceutical industry
The necessary flow of information from production to quality control and vice versa is supported by ourLABS/Q®LIMS laboratory software. Production orders can be imported via interfaces, such as those to ERP systems, which automatically create the required sample-specific and process-specific in-process control test orders and the release test order according to the rules defined in the master data. Traceability of the production batches back to the raw material is consistently ensured. Packaging and the creation of customer-specific certificates upon delivery are also supported. The results and usage decisions can be transferred to the ERP system or viewed by the production facility using theLABS/Q®LIMS pharmaceutical laboratory software. Production conditions in biotechnology can be verified and documented via hygiene monitoring through automatically created test orders.
An Overview of Our Laboratory Software
The following outlines the tasks where the products we offer in the field of pharmaceutical technology can assist you and help you save time and money:
- Optimizing Active Ingredient Yields withLABS/Q® LIMS (LABS/Q LIMS)
- Development/Optimization of Dosage Forms UsingLABS/Q® LIMS (LABS/Q LIMS)
- Production of clinical samples usingLABS/Q® LIMS (LABS/Q LIMS)
- Release testing, stress testing, stability testing (LABS/Q/stability studies)
- Method Validation with VALIDAT (VALIDAT/Method Validation)
- Evaluate release tests using VALIDAT (VALIDAT/Drug Release)
- Method Transfer with VALIDAT (VALIDAT/Method Transfer)
- Management of Samples
Research and Development in the Pharmaceutical Industry
Your requirements for pharmaceutical laboratory software
Drug development—which begins with drug discovery and extends through the development of the dosage form and the preclinical and clinical phases to the finished drug—involves a significant investment of time and money. In this process, a wide variety of laboratories with diverse responsibilities work closely together.
In addition to identifying new active ingredients, research is already focused on their effective production. At the same time, analytical methods for testing the active ingredient and its byproducts/metabolites must be developed and validated. The dosage form is developed and tested for effectiveness. Once the drug is approved and in production, these methods must be transferred to the quality control laboratories.
Our pharmaceutical lab software designed to meet your high standards
Our proven products can help you with your tasks while saving you time and money. Are you looking for the right software for your lab? Contact us—we’d be happy to advise you and help you find the best solution for your specific needs.
Pharmaceutical and Biopharmaceutical Laboratory Software: Quality Control
Our Products for Quality Control and Quality Assurance
Every pharmaceutical product is only as good as the quality of its manufacturing and testing. The highest quality standards, along with fast and reliable processes in pharmaceutical and biotechnology laboratories, are among the most important factors for the success of any company. Quality control tasks in the regulated sectors of the pharmaceutical industry and biotechnology include, among other things, the testing and release of raw materials, packaging materials, and intermediates, all the way through to the finished drug product. The continuous updating of testing methods, including their validation, the suitability and calibration of laboratory equipment, as well as the testing and monitoring of numerous reference standards are also essential tasks of quality control. Furthermore, in quality control, medicinal products are stored for stability testing under controlled climatic conditions in accordance with ICH guidelines and analyzed until their expiration date. For solid dosage forms, release testing is also conducted.
Our laboratory software products can provide you with significant support in your quality control and quality assurance tasks, thereby saving you time and money.
The following section explains which product can help meet your needs:
- Management of specifications, test plans, and methods (LABS/Q LIMS)
- Test Order Processing / Deviation Management / Stability Testing (LABS/Q LIMS)
- Internal Quality Control of the Laboratory (LABS/Q LIMS)
- Graphical and statistical analyses, reports (LABS/Q)
- A revised method must be revalidated (VALIDAT)
Environmental and Hygiene Monitoring in the Pharmaceutical Industry
Support from our software products
In a manufacturing facility, continuous monitoring of hygiene (water, equipment, personnel, rooms, etc.) and the environment (e.g., wastewater, air pollution, emissions) throughout the production process is essential.
With our LABS/Q® LIMS laboratory software, you get a LIMS solution that includes a dedicated module for environmental and hygiene monitoring. This allows for the automatic triggering of both production-related and scheduled tests at 1 to n sampling points via so-called project orders. A group reporting function, in conjunction with LABSGraphic, enables convenient graphical and statistical analysis of the data.
Further information
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