Throughout more than twenty years, VALIDAT established itself as the leading software solution for efficient method validation. Today VALIDAT supports validation documentation according to regulations for our customers in pharmaceutical, chemical, or biotechnical industries, in petrochemist ... more
LIMS – Method Validation – Raw Data Archiving – SAP Integration - IoT
Cross-Industry Laboratory Application, Which Has Been Used Successfully for More than 30 Years
Freely configurable dashboard online, bar, pie charts, and other graphic elements, including the direct call of the LABS/Q® modules
Example of a stability analysis, the graphical and statistical analysis functions are shown. The LABSGraphic part of LABS/Q® offers various graphical and statistical analysis functions
The test- and measuring equipment monitoring is the backbone of the AQA in the lab and replaces the device management books as well as it helps keeping track of the standard and control samples
App for mobile result entry and sampling (online and offline) for Android and Apple iOS (here Android is shown) and subsequent transfer to LABS/Q®
The LABS Suite consisting of the LIMS LABS/Q®, the Recipe Information and Management System (RIMS) LABS/R, and the SAP Middleware LABS/QM for direct connection of any kind of analytical instruments and systems to SAP QM in addition the software for method validation VALIDAT form the backbone of a modern laboratory. The LABS Suite as well as VALIDAT provide the means to fulfil current requirements for accredited and quality assured laboratories, especially in a GxP environment.
The modularly structured LABS Suite and VALIDAT support the following business processes:
- routine testing for quality and in-process controlling
- handling of hygiene and environmental monitoring
- execution of stability studies
- analytical quality assurance AQA, test equipment, OOS / OOT, round robin tests
- contract analysis for service laboratories
- integration of laboratory data into the SAP Leonardo IOT platform and evaluation with SAP Analytics Cloud
- optimization of chemical synthesis or recipes
- development and validation of analytical methods
- drug release / dissolution and its evaluation
With LABS/Q® we offer a universally applicable, exceptionally flexible system that covers LIMS, LES and raw data archiving functionality. These functions can be adapted to your workflows since they are highly configurable. The screen layout and database tables can be individually extended and supplemented without affecting a release change. Various tools (e. g. SAP Crystal Reports and JasperReports) are supported for reporting and label design. The standard installation already supplies more than 250 report and label templates.
The use of LABS/Q® across all locations and in all organizational sizes is ensured by multilingualism, not only for screen masks, but also for data content and reporting, as well as time zone support.
LABS/R as a software for recipe management used for the optimization of chemical syntheses or recipes provides the possibility to support the operating processes as integration platform, from the planning of the experiment up to the evaluation of the tests. LABS/R even can be used for recipe optimization as a stand-alone solution or can be purchased as an extension for LABS/Q® LIMS. LABS/R can optionally be combined with DoE software such as Modde or Stavex for statistical design and evaluation of experiments. A combination with the laboratory journal OpenLAB ELN is also possible.
The integration of mobile devices such as tablet PCs with special Apps opens the way to a paperless laboratory.
The direct connection of equipment and analysis systems to LABS/Q ® reduces the effort as well as minimizes potential errors in gathering and transferring samples and measurement data dramatically. A raw data archiving and implementation in the AnIML (Analytical Information Markup Language) format allows in addition to archive, and, via the corresponding LABS/Q® Viewer, to display the raw data (e. g. chromatograms, spectra, etc.) directly, without the need for the respective original software.
Flexible interfaces of LABS/Q® support the integration of additional applications (e. g. ERP, MES, DCS). As an SAP Silver Partner iCD. will give you professional support in the SAP environment on the one hand by the certified all-purpose configurable SAP interface (via WEB services directly or via PI), on the other hand by our services.
The SAP Middleware LABS/QM provides the opportunity to connect analytical instruments and systems directly to SAP QM. A manual data entry with the possibility of incorrect entries is completely avoided. In addition, the SAP middleware LABS/QM increases the degree of automation in the laboratory and contributes significantly to increasing the efficiency of the employees, which leads to a cost reduction of the entire laboratory process. The integration of production and laboratory data to control product and process quality can bring significant added value to the chemical industry. The "Connected Lab" application supports vertical integration for chemical production and quality management using SAP Leonardo IoT on the SAP cloud platform and evaluation with SAP Analytics Cloud.
Validation of analytical methods is a basic precondition for every analytical laboratory, and a prerequisite especially for GxP and ISO 17025 regulated laboratories. VALIDAT guides you safely through the planning, execution, evaluation and extensive reporting process steps. In this way you save a significant part of your previous work and at the same time you will fulfil regulations of DIN, ISO, USP and ICH.
Our experience built up in more than 30 years, especially in regulated environments, as well as the continuous development of iCD. products in cooperation with our customers (Task Force, user meetings), give you investment protection and the security of a successful implementation and support of the system.
If you have any questions or need a quote request information now!
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