A compliant way to digitalize your GMP paper documentation

Um den höchsten Qualitätsstandard innerhalb des Prozesswesens liefern zu können und den Anforderungen der Kunden, Behörden und Regularien hinsichtlich Lohnanalytik gerecht zu werden, bedarf es einer digitalisierten Umgebung (digital environment) im Labor, welche sich mit den Schlagwörtern Data Integrity, e-compliance und LIMS (Laboratory Information Management System) bestmöglich beschreiben lässt.

Unser neu-entwickelter Prozess der digitalen Transformation von Papierdokumenten entspricht den geltenden regulatorischen Anforderungen.

Cost Saving QCThomas Pfeifer2. Jänner 2019digitalization, converting GMP documentation

Efficiency within Quality Control, UHPLC conquering PHARMA

UHPLC technology provides high analysis speed, better chromatographic resolution, performs more sensitive analysis, consumes less time, reduces solvent consumption. Although these facts are proven, the implementation if this technology shows only slow progress within the quality control of pharmaceutical.

We have developed a strategy how methods can be transformed and all the benefits including cost savings can be seen in short time.

We provide Business case, Regulatory Strategy and Registration Documents, Method Validation Documents according to ICH, Testing Procedure and Project Plan.

Cost Saving QC, Forschung und EntwicklungThomas Pfeifer21. August 2018UHPLC, PHARMA, QC Efficiency, cost savings, Raw Material Testing

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