Qualogy Limited

Qualogy’s Regulatory Archive Service is a fast growing, professional archive, providing high quality archive services in compliance with the Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations. Dedicated solely to the archiving of GxP regulated material we offer a personal service for each client based upon knowledge of the requirements, which are then geared to the needs of individual clients. Archive security and preventative measures are key to running a exceptional regulatory archive business. Fire monitoring and security alarms, fire suppression system, laser beam smoke detection, CCTV, temperature and humidity control and continuous monitoring are all in place within the archive facilities. With separate buildings on one site we are able to archive Investigator Site Files (ISF’s) and Trial Master Files (TMF’s) or back up material in separate buildings. Qualogy runs GCP and GLP archive training course twice throughout the year. Through Qualogy’s long experience working with clients from around the world Qualogy has an unsurpassed expertise in assisting organisations improve the quality systems implemented for compliance with the global GxP regulations. Providing through its consultancy service guidance and expertise in the implementation and operation with Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP). Qualogy designed an accreditation scheme to access a laboratories compliance with the standards of GCLP. The Qualogy GCLP accreditation scheme involves the assessment of a clinical laboratory against the Good Clinical Laboratory (GCLP) standard as published by RQA, formerly the British Association of Research Quality Assurance (BARQA). The Good Clinical Laboratory Practice guideline ISBN 978-1-904610-00-7, which has been adopted by the World Health Organisation (WHO), can be freely obtained from the RQA web site at www.therqa.com