Dear All
The GHTF (Global Harmonization Task Force) has issued following draft guidance documents on 16th September 2009 to assist regulators and auditing organizations to carrying out QMS audits of medical device manufacturers with multiple sites.
SG4/N83R5:2008 -Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4: Multiple Site Auditing
SG4/N30WD1:2009- Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy
Also released, SG2/N38R19:2009-Application Requirements for Participation in the GHTF National Competent Authority Report Exchange Program.
Thanks and Regards
S. Subramaniam
The GHTF (Global Harmonization Task Force) has issued following draft guidance documents on 16th September 2009 to assist regulators and auditing organizations to carrying out QMS audits of medical device manufacturers with multiple sites.
SG4/N83R5:2008 -Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4: Multiple Site Auditing
SG4/N30WD1:2009- Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy
Also released, SG2/N38R19:2009-Application Requirements for Participation in the GHTF National Competent Authority Report Exchange Program.
Thanks and Regards
S. Subramaniam