The Impact of Digital Lab Assistants on Good Manufacturing Practices (cGMP) and Data Integrity

The Impact of Digital Lab Assistants on Good Manufacturing Practices (cGMP) and Data Integrity

Current Good Manufacturing Practice (cGMP) regulations require that companies maintain minimum standards for processes, equipment, facilities and quality management systems. However, it can be challenging to accurately record and track various data..

Microbiological Testing in cGMP-environment with LIMS and MES software

Microbiological Testing in cGMP-environment with LIMS and MES software

We all expect that the medicine we receive is safe and effective. For pharmaceutical products to meet these requirements, regulatory authorities, such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA), ensure..

Using Voice Entry to Increase Data Integrity in cGMP (Pharma) Sample Preparation

Using Voice Entry to Increase Data Integrity in cGMP (Pharma) Sample Preparation

Data integrity is not a new problem and continues to be the major focus in regulated cGMP laboratories worldwide due to data falsification, poor data management practices, or ignorance of the regulations. Several regulatory agencies such as the..

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