FDA Regulations and Auditing Practices for Software Suppliers at a Pharmaceutical Manufacturer

@inproceedings{Theisen2004FDARA,
  title={FDA Regulations and Auditing Practices for Software Suppliers at a Pharmaceutical Manufacturer},
  author={T W Theisen and Colin J. Neill},
  year={2004}
}
ware-supplier auditing practices in the pharmaceutical manufacturing environment by reviewing 17 quality audit reports performed between 1992 and 2003 by a major international pharmaceutical company. From this analysis three novel time frames of audit maturity (eras) are defined on the basis of government regulation enforcement patterns, supplier quality… CONTINUE READING