+44 (0)1933 357953 info@qualogy.co.uk

Regulatory Archiving

Qualogy’s Regulatory Archive Service is a fast growing, professional archive operation, 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. 

Facilities

The archive facilities are managed and operated in accordance with the exacting standards required by the Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations. The archive is managed and operated by an experienced archive team.

We pride ourselves on having an efficient and effective quality system with high standards in all our activities. Archive security and preventative measures are in place including fire monitoring and alarms, fire suppression system, laser beam smoke detection, CCTV, temperature and humidity control and continuous monitoring.

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.

Our systems have been inspected by the UK GLP Regulatory Monitoring Authority (MHRA).

Onsite viewing of material – Qualogy can provide clients with a viewing room and copying facility on site to enable clients to view their archived material at their convenience. Requests for the use of this facility should be made in advance to ensure availability of the room.

Logistics and transportation

Transportation of the material from the client, CRO or investigator site to the archive facility can be undertaken by Qualogy’s own dedicated transport service. Door to door transportation of a single client’s material is undertaken. Qualogy can liaise directly with the sites/CRO’s on your behalf to arrange collection of the material.

Full chain of custody records are maintained throughout the service giving the client traceability and auditable documentation at every stage. All chain of custody documentation is retained with copies being sent to the client.

A dedicated space within the archive is allocated to each client thus enabling all material of a client being located together. Once archived clients material will not be moved within the archive or between archives unless requested.

Centralisation

Centralising your material could prove to be cost effective, enabling your company to have a single location for all material. We can advise and liaise with clients and sites to assist in the logistics of relocating material.

Boxes and packaging – Qualogy can provide quality archive boxes for the secure long-term storage of material for the same cost as many stationers.

Security and confidentiality – The secure archive area is operated in accordance with documented standard operating procedures (SOPs) and stringent environmental and security controls. Client anonymity is maintained at all times.

Indexing – Each clients material is kept together and archived in a numerical order. Our personal indexing system means fast efficient retrieval when necessary. With the knowledge of where your data is at all times.

Secure confidential destruction

On-site secure destruction of paper material and off-site destruction of histology slides, wax blocks, wet tissue and electronic media can be provided. Specialised services for destruction of material classed as clinical waste (wax blocks, wet tissue and histology slides) have been audited and approved. A certificate of destruction is issued upon completion of the destruction which verifies that materials have been destroyed in accordance with current laws and client requirements.

Archive consultancy and training

Consultancy services can be provided to advise and assist clients on the design and/or operation of a regulatory archive facility. Training of staff in compliance with both GLP and GCP can also be undertaken. Regular public archive training courses are held at Qualogy (twice a year) to assist with the training of Regulatory Archivists. The archive courses can also be provided in-house tailored to your company’s needs.

For further information on the archive training courses please visit our Archive Training page.

For further details please contact us

By phone 01933 357 953

or by email archives@qualogy.co.uk

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