Coronavirus Update - 07th August 2020

We would like to take this opportunity to thank our clients and staff for their continued support over this period of restricted movement. 

We remain open for business as usual and have started welcoming limited numbers of visitors to site

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Industry Insights ... Scientific Records

Preservation of Scientific Records

The acquisition and analysis of experimental data is the foundation of all scientific research, including pharmaceuticals. However, it doesn’t end there. This vital information then has to be stored appropriately, and in accordance with the exacting standards set by Good Laboratory Practice (GLP) regulations. Scientific archiving facilities must also preserve client confidentiality at all costs, in addition to offering protection from environmental damage caused by flooding, infestation, fire and damp. By outsourcing data archiving, the need for pharmaceutical companies to build and maintain costly storage facilities is removed. At Arcinova, we offer our partners a streamlined archiving solution as part of our integrated services - in a secure, purpose-built facility that preserves both documentation and client confidentiality. Read on to learn more about how important scientific data is stored in a strict regulatory landscape.

Why are documents/samples stored?

Study data must be retained to allow GLP inspectors to assess its quality, and whether the study undertaken was GLP compliant. Also, to preserve from unauthorised alternation following data generation. According to official MHRA regulations, documents should be stored for at least one inspection cycle at the facility where they were generated, lasting typically 2-3 years. If it is not possible to keep the source material for this long, accurate copies must be made and stored in their stead. 

General building requirements

From orientation to internal plumbing, there are a wide variety of factors that must be considered during the construction of an archiving facility. The building should be correctly orientated to minimise sunlight, and care must be taken to avoid water or waste pipes running over storage areas. Thick walls, minimal windows and a strong roof help to provide insulation from the external environment. The facility should also be designed to prevent flooding, leaks and infestation damage. Walls, floors and ceilings should be chemically inert and cleanable, and the wall and roof construction should be fire resistant. At Arcinova, we offer a separate sample storage area with independent air handling for maximum security.

Temperature, humidity and fire prevention

To prevent damage to documentation, temperature and humidity within the archiving facility must be strictly regulated. Official recommendation for the storage and exhibition of archival documents in the UK, BS5454:2000, state that the temperature should remain at a fixed point between 16-19ºC, and provide a fixed level of relative humidity between 45-60%. Within Arcinova’s facility, these parameters are tightly controlled, and alarmed via an independent environmental monitoring system. In an isolated area containing a variety of important - and flammable - documentation, fire prevention is also crucial. At Arcinova, our storage facility offers 120 minutes of fire resistance, and boasts a fire detection and inert gas suppression system. Our storage area shelving is constructed of high-density rolling shelves that provide additional protection against fire and water damage.

Security and confidentiality

Confidentiality is paramount. A number of steps are taken to ensure complete client anonymity and to establish a chain of custody. At Arcinova, we allocate a dedicated area to each client to ensure all records are kept together, and each box is uniquely identified in numerical order. Once archived, client material is not moved within the archive or between archives unless specifically requested. Traceability is maintained throughout the storage period through accurate record-keeping, ensuring clients have full visibility. Stringent security controls are imposed, as well as a personal indexing system for fast and efficient retrieval.  A dedicated/secure viewing room and copying/scanning facility is available to enable clients to view their archived material in confidence and at their convenience. The Archive Facility is managed and operated in accordance with the exacting standards required by the MHRA, under the control of a dedicated/trained Archivist. 

Summary

Scientific archiving facilities are complex, requiring strict management to preserve documentation confidentially. At Arcinova, we are strongly aware of these requirements. For peace of mind and cost-effectiveness, outsourcing document archiving to regulatory experts can often be the most practical course of action.

Get in touch to learn more about our secure, purpose-built archiving facility here

 




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