Ghtf guidance supplier management software

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. Ghtf sg3 quality management system medical devices. Ghtf sg3 qms process validation guidance january 2004. Managing supplier purchasing controls ghtf guidance. Ghtf guidelines for regulatory auditing of quality management systems of. Guidelines for regulatory auditing of quality management. Same supplier may have different risks for different. These documents were created by the global harmonization task force ghtf. 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. The purpose of the ghtf is to encourage a convergence in standards and regulatory practices related to the safety, performance and quality of medical. This supplier quality seminar provides the tools and techniques to help your teams manage the supplier base.

Ghtf study group 3 quality systems process validation guidance draft february, 1999 page 3 1 purpose and scope 1. The ghtf guidance is a useful educational tool for. Medical device supply chain management, ghtf guidance. Guidance on the control of products and services obtained from suppliers. Quality management systems process validation guidance, originally. A quick diff on both versions of the guidance shows that there is news about software. Quality management system medical devices guidance on the. Supplier documents, calibration, preventative maintenance and spare parts. Until that time, these documents are provided for the use of interested parties. Ghtf sg4 guidelines for regulatory auditing of quality. Ghtf guidance also strongly recommends that you have. Pdf guidelines for regulatory auditing of quality management.

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. 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. 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. This guidance document is intended for medical device manufacturers and it is expected. Supplier control is a much bigger issue now than it was in 2007. The fda also mandates that software used for the design, manufacture.