Qualogy offer a secure regulatory archive service providing high quality contract archive services. The archive facilities are operated to the exacting standards required by Good Laboratory Practice (GLP) Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) regulations. With documented standard operating procedures (SOP’s), environmental controls and stringent security and fire prevention systems in place.
Qualogy was founded in 1997, Qualogy Ltd operates an independent consultancy company, specialising in providing expertise to organisations that are required to implement GLP and GCP regulations. The company was founded by Tim Stiles who has worked in the arena for over 30 years. Tim was the Director of Quality Assurance for a large Contract Research Organisation (CRO). Tim was involved in the inception of the British Association of Research Quality Assurance (BARQA) professional development courses within the UK. He has lectured, audited and trained in Europe, Africa, India, USA, Asia, South Africa and Japan on GLP and GCP and GCLP. Tim along with a colleague produced the GCLP document “Good Clinical Laboratory Practise 2003 ISB 978-1-904610-00-7 published by BARQA.
In the course of the company’s consultancy, the need for a secure and reliable independent archive facility was identified.
The archive facility was originally established in 2000 for the storage of Investigator Site Files (ISFs) and other GLP/GCP/GMP materials on behalf of sponsor and client organisations.
The archive is managed by an experienced Archivist, qualified in scientific Archive Management, and with over 20 years experience in the operation of a regulatory archive. She was a member of the working party which helped the MHRA produce the document “Good Laboratory Practice, Guidance on Archiving”.
Qualogy’s facilities have been successfully inspected by the MHRA.
Services offered include:
- Secure and safe Storage of material.
- Confidentiality and Client anonymity of stored material.
- Dedicated service for ISF’s, TMF’s, GLP, GCP, GMP and GCLP.
- Operated according to regulatory requirements.
- Full detailed chain of custody from point of collection.
- A complete inventory of client material maintained.
- Temperature and humidity controlled archive.
- Intruder Alarm, CCTV.
- Smoke and fire detection and automatic fire suppression system.
- Private courier service for the transport of material.
- Supply of boxes on request.
- Archivist training course. This course can also be run in-house and can be tailored to meet your company’s requirements.
- Implementation of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Clinical Laboratory Practise (GCLP).
- Courses in Archiving, GCLP, GCP, GLP.
- GCLP Clinical Laboratories Accreditation
- Training for Laboratory staff.