| Used in the area of QA/QC the extensive set of the LABS/Q® functions and modules supports all GMP relevant activities (checking raw materials, in-process-control (IPC), testing bukware and final products, shipping of packed products with related certificates). Using LABS/Q® in these industries, the solution’s main focus is set to sampling issues, OOS (out of specification), FID (failure investigation / deviation), usage decisions, stability studies, and certificate management. LABS/Q® supports all actual requirements of the 21 CFR Part 11 "Electronic Records" and "Electronic Signatures" guidelines. All projects are handled in accordance with the GAMP 5 guidelines. |
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/Pharmaceuticals / Biotechnology
(Pre-Registration)