Feb 1 2010
KIKA™ Clinical Solutions announced the successful completion of its ISO renewal audit for its operations in the U.S. and France. KIKA is the leading provider of advanced EDC solutions for Clinical Asset Management™ for the pharmaceutical, biotechnology and medical device markets.
KIKA renewed for the updated ISO standard ISO 9001 version 2008. The certification body was SGS, the world's largest control and inspection company.
ISO recertification requires an annual follow-up audit and a more thorough renewal audit every three years. Renewal is not automatic. For this audit KIKA had a new ISO auditor, which offered a fresh eye to ensure that KIKA's QMS compliance was entirely consistent.
KIKA CEO Linda Beneze commented, "It's especially important for customers and partners that our ISO renewal audit covered all of KIKA's operations and processes worldwide. It guarantees global uniform processes for sponsors conducting multi-country clinical trials with our Veracity™ advanced EDC solution."