Ghtf guidance supplier management software

This guidance document is intended for medical device manufacturers and it is expected. The fda also mandates that software used for the design, manufacture. The global harmonization task force ghtf was founded in 1993 by the governments and industry representatives of australia, canada, japan, the european union, and the united states of america. Ghtf study group 3 quality systems process validation guidance draft february, 1999 page 3 1 purpose and scope 1. These documents were created by the global harmonization task force ghtf. This guidance has been developed by the appropriate ghtf expert study group study group 3 and has been subject to consultation by the regulatory parties. Supplier documents, calibration, preventative maintenance and spare parts.

Ghtf guidance also strongly recommends that you have. Ghtf guidelines for regulatory auditing of quality management systems of. The ghtf guidance is a useful educational tool for. To continue with the discussion about software validation in my three last posts, this is a new proof of the rising concept of software validation new section added about software. Supplier control is a much bigger issue now than it was in 2007. Same supplier may have different risks for different. Pdf guidelines for regulatory auditing of quality management. Ghtf sg4 guidelines for regulatory auditing of quality. Managing supplier purchasing controls ghtf guidance. A quick diff on both versions of the guidance shows that there is news about software. Quality systems, chair of ghtf study group 3 fda is taking steps to recognize sg3 through good guidance practices procedure fda is referring to sg3 in training and encouraging industry to use the guidance kim trautman.

Ghtf sg3 quality management system medical devices. Guidelines for regulatory auditing of quality management. Medical device supply chain management, ghtf guidance. Until that time, these documents are provided for the use of interested parties. Health canada is pleased to announce the adoption of the ghtf guidance quality management system medical devices guidance on the control of products and services obtained from suppliers. Guidance on the control of products and services obtained from suppliers. Quality management systems process validation guidance, originally.