Tag: quality management systems

  • Quality (QA QC QMS) Deficiencies

    Quality (QA QC QMS) Deficiencies

    In May of this year I did a posting on the Quality Management Systems (QMS) that are obligatory for DS/PV departments based on FDA’s Quality Manual and the EMA’s Good PV Guidelines Module 1. Since then I have done many audits of drug safety and PV groups around the US and Europe and, sad to…