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To
ensure quality and consistency in every facet of our operations
and to comply with GCP and other regulatory requirements, ICON Central
Laboratories maintains over 300 standard operating procedures (SOPs)
that are reviewed annually for accuracy. These SOPs guide our daily
operations and serve as the foundation for ICON Central Laboratories’
employee training programs.
The Quality Assurance Department is
integrally involved with each operating department in the development
and maintenance of these SOPs. A comprehensive set of all company
SOPs is maintained by the Quality Assurance Department. They are
available for review by sponsors when they visit our facilities.
The Quality Assurance Department at
ICON Central Laboratories archives all study documents and electronic
data to comply with ICH/GCP guidelines. In accordance with these
guidelines, study-related materials are retained for a minimum of
15 years. ICON Central Laboratories has a secure, FM200 waterless
fire suppression protected room, designed for this purpose. Only
authorized Quality Assurance personnel have access to this restricted
area. In addition to our own on-site storage facilities, our company
contracts with a reputable commercial provider of archival services
to meet additional off-site document storage needs. These facilities
have been selected based upon their ability to meet the industry’s
standards regarding a fireproof environment with highly restricted
and controlled access.
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