Current Edition

QUALOGY REGULATORY ARCHIVE

Qualogy’s Contract Regulatory Archive Service is a fast-growing secure archive providing high quality archiving Dedicated to the GxP regulated industries.

 

The archive facilities are operated to the exacting standards required by the Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) Regulations and the Good Clinical Laboratory Practice (GCLP) guidelines.

 

Founded in 1995, Qualogy Limited began as an independent consultancy company, specialising in providing expertise to organisations that are required to implement the requirements of Good Laboratory and Good Clinical Practice.

 

The company was founded by Tim Stiles, who has worked within the regulatory arena for 40 years, including working as the Director of Quality Assurance within a large Contract Research Organisation (CRO).

 

Tim was involved in the inception of RQA (formerly BARQA QA) professional development courses within the UK and has lectured and trained in Europe, Africa, Asia, US, on GLP and GCP topics.

 

In the course of the companies consultancy business, the need for a secure and reliable independent contract archive storage facility for Investigator Site Files (ISFs) was identified.  In response to this identified need, our archive facility was established in 2002 for the archive storage of ISFs and other GLP/GCP/GMP materials on behalf of sponsor/client organisations.

 

The archive facility is operated by an experienced Archivist with over ten years of experience and managed by an Archive manager qualified in Scientific Archive Management.

 

The Archive facility is operated in accordance with documented standard operating procedures (SOPs) and stringent environmental and high levels of security, which include intruder and fire monitoring and alarms, fire suppression system, CCTV, temperature and humidity control and continuous monitoring and preventative measures.

We pride ourselves on being very customer focused and we work closely with our clients to offer a service that is tailored to our client’s needs.

Our trained and dedicated team can liaise directly with sites to assist in moving material to our archive.

Centralising your worldwide archive material with Qualogy could prove to be more cost-effective, enabling your company to make significant savings. 

We provide

  • Secure and safe storage of materials
  • Confidentiality and client anonymity of stored material
  • Dedicated service for GLP, GCP, GMP and GCLP material
  • Operated according to regulatory requirements
  • Independent storage of Investigator site files and Trial Master Files
  • Facilities operated and managed by an experienced Regulatory Archivist
  • Private transport service for archive material
  • Rapid retrieval of material
  • Supply of boxes
  • Scan on demand
  • No hidden costs

 

If you require further information on any of the services provided by Qualogy please contact:

The Archivist

Qualogy Ltd

Email: archives@qualogy.co.uk

Telephone: +44 (0)1933 357953

Web Address: www.qualogy.co.uk