Best-in-Class GLP Archiving

A large, global agrochemical enterprise determined that to streamline operational expenses, it needed to reallocate the resources and personnel who support its campus-based research toxicology laboratory. The laboratory conducts studies adhering to good laboratory practice (GLP) principles and had a proprietary specimen, blocks and slides GLP archive. After an extensive benefit-cost analysis to estimate the strengths and weaknesses of archiving alternatives, it became obvious that outsourcing archiving from the toxicology laboratory to a contract facility would be the right approach to achieve savings.

The agrochemical enterprise reached out to Quality Assurance Consultancy for guidance and support because of our premier archiving facility, as well as our archivists with unmatched expertise and domain knowledge gained from years of experience in the industry. Quality Assurance Consultancy’s team of archiving specialists arranged the transfer of materials generated at the toxicology laboratory. Highlights of the transfer include the following:

Size of the Initial Transfer: Quality Assurance Consultancy successfully transferred approximately 5000 cubic feet of material, which equated to about 4000 standard banker record boxes.

Duration of the Transfer: Quality Assurance Consultancy completed the transfer over a period of several months adhering to our established, best-in-class policies defining how materials should be stored securely and safely.

Inventory Verification: To ensure quality control, Quality Assurance Consultancy performed a complete inventory of all materials according to the level of detail we recommended and established with the agrochemical enterprise customer.

Inventory Tracking: Quality Assurance Consultancy entered all inventory material into our premier tracking database to identify each item by the: box identification; date received; material type; and location from which it was transferred.

Inventory Access: Quality Assurance Consultancy set up a process so that when the agrochemical enterprise customer needed materials for re-examination, both parties could effectively manage all requests and delivery requirements (same-day courier, overnight- or standard-ground delivery) while maintaining a complete chain of custody.

Outcome:

Through our industry-recognized approach and specialized expertise, Quality Assurance Consultancy worked in partnership with the agrochemical enterprise customer. Together, we were able to design an outsourced archiving solution that met the customer’s unique needs while adhering to both regulatory and Quality Assurance Consultancy’s best-in-class internal processes. As a result, the agrochemical enterprise customer was able to reduce the time and expense involved in archiving critical materials realizing as much as $300,000 in savings associated with annual operating expenses* while achieving greater value from Quality Assurance Consultancy’s specialized archivists managing the material. The agrochemical enterprise customer continues to rely on Quality Assurance Consultancy to securely store its GLP specimens, blocks and slides—while Quality Assurance Consultancy regularly receives shipments directly from the agrochemical customer or its sponsored contract research organizations (CROs) in the U.S. and Europe.

* Based on an annual estimate of operating expenses for a 9,300 square foot archiving facility