LABS/Q LIMS provides a unique platform that supports the complete workflow in Pharma from R&D over IPC up to the final release of the procuct including environmental control and hygiene monitoring. Consequently besides QC-related laboratory inspections LABS/Q LIMS supports also management of samples of different origin and related analytical results in R&D. These samples may originate from chemical synthesis of a new drug or subsequent galenical formulation developments.
Inspections may belong to routine inspections of a project or a series of tests and result from optimization of yield of a single compound or the entire recipe, or belong to unplanned samples where the scope of investigation must be determined in a very quickly manner.
The R&D module of LABS/Q LIMS supports the management of the above mentioned projects and test runs and helps to generate test series on basis of a recipe and process-related steps, and support of a statistical design of experiment (DoE). For more details please see LABS/R.
Production in Pharma
The necessary flow of information from production to quality control and vice versa in LABS/Q LIMS is considered in many places. Production orders may be imported from ERP systems by specific interfaces and automatically create IPC-related inspection orders specific for sampling points or operation steps, as well as inspections for final release according to the rules pre-defined in the related master data set. For batches a complete backtracking until the raw material used with full traceability is ensured throughout. Likewise, packaging and creation of customer-specific certificates at delivery is supported. The results and usage decisions can be transferred to the ERP system, or reviewed from the production site within LABS/Q LIMS.
Production conditions can be checked and documented via hygiene monitoring test orders automatically generated by the LIMS. For more details also see hygiene monitoring.
Quality Control in Pharma
LABS/Q LIMS supports all GMP-relevant activities as part of the quality control. All processes related to inspections of incoming goods, in-process control (IPC) and final inspection of intermediate and final products up to packaging and delivery of goods including certificate generation is supported. Special attention is paid to the topics of sampling, OOS (out of specification), FID (failure investigation & deviation), usage decision, stability testing, and certification management. Of course current requirements of 21CFR11 "Electronic Records" and "Electronic Signatures" are supported, and projects are in accordance with GAMP5 guideline.
Environmental Control & Hygiene Monitoring in Pharma
Also for hygiene monitoring LABS/Q LIMS provides all functionalities helping to automatically executing tests of the environment and of resources used (clothing, air, water, cabinets, etc.) at regular intervals and also batch-related. If filling orders are entered via interfaces into the LIMS or manually generated within LABS/Q LIMS, the necessary inspection orders with the correct scope of testing for the different filling modes will be created automatically.