The company has renewed for the updated ISO standard, ISO 9001 version 2008 from the certification body, SGS. ISO recertification requires an annual follow-up audit and a more thorough renewal audit every three years. For this audit, KIKA had a new ISO auditor that offered a fresh eye to ensure that company's QMS compliance was consistent.
Linda Beneze, CEO of KIKA, said: "It is 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."
KIKA helps the medical device organizations to use advanced EDC solutions in bringing much-needed medical solutions to market faster. The company's Veracity is a web-based clinical trial software platform that delivers Clinical Asset Management for any size of clinical trial.
Veracity is customized to meet study needs precisely, claims the company. It provides flexibility and customization with advanced EDC, including images and online adjudication, and is backed by a reliable IT infrastructure.