CAPRISA laboratories receives a clean audit

26 September 2016

CAPRISA congratulates the Laboratory team for receiving an excellent audit by FHI360/ Westat. This follows an audit from 2629 July for studies that include IMPAACT, HVTN, HPTN and MTN.

The CAPRISA main laboratory as well as the site laboratories at the eThekwini and Vulindlela Research Clinics underwent intense audit of the Quality Management Systems for compliance to the ISO 15189:2012 Standard and Code of Federal Regulations 42 part 21. The audit reports received on 31st August and 9th September “had not a single finding or observation at all of the CAPRISA Laboratories”, explained Ms Natasha Samsunder Director CAPRISA Laboratories. “This was an amazing accolade and evidence of the strong quality management system in place across all CAPRISA laboratories. “ She lauded laboratory staff and said, “credit for this amazing achievement has to be awarded to all of the CAPRISA Laboratory staff who ensure that quality is the highest priority and adherence to the quality management system is effectively integrated into daily functioning of the laboratories.” CAPRISA laboratories are accredited by the South African National Accreditation System (SANAS) as well as international laboratory accreditation authorities like DAIDS DCLOT and PPD. The laboratory quality management system is in accordance with the Code of Federal Regulations Title 42: Public Health, Part 493 Laboratory Requirements;  Title 21: Food and Drugs, Part 58 Good Laboratory Practices for Non-Clinical Laboratory Studies and ISO International Standard 15189 Medical Laboratories for quality and competency requirements.

From  L-R (Front Row): Shannie Kamal, Natasha Samsunder, Phindile Tshabalala. Back  Row (L-R) ): Panji Pillay , Zanele Mchunu, Lenine Liebenberg, Athena Lemon, Ross Cromarty, Chéli Kambaran, Jacqui Kasavan, Damien Sookoo, Sahil Tulsi, Sanele Mhlungu, Ashley Singh