Some help might be at hand, with the recent publication of another regulatory guidance document in the Good Laboratory Practice (GLP) arena that gives guidance to workers in nonclinical studies and bioanalytical. It comes with the snappy title of Establishment and Control of Archives that Operate in Compliance with the Principles of GLP and was published by the Organization for Economic Cooperation and Development (OECD) in June 2007 (1). This is the organization that is responsible for generating GLP regulations outside of the US and Japan. So let's see what this document can do for us in the spectrometry laboratory.
In the Beginning . . .. . . there were GLP regulations. Archiving of records and study materials generated during the course of a nonclinical health-safety study is a specific requirement of GLP. The rationale for the archive is that maintenance of the raw data associated with a specific study and the specimens generated from that study are the only means that can be used to reconstruct the study and enable the information presented in the final report to be verified.
The archive is a secure facility or room with an archivist specifically responsible for logging material in and out of the archive. Security and access are major issues within a GLP archive: only authorized personnel have access. This is not the case with GMP regulations.
The key definitions in this document are as follows:
Archive: A designated area or facility (such as a cabinet, room, building, or computerized system) for the secure storage and retention of records and materials.
Archivist: An individual designated by test facility or test site management to be responsible for the management of the archive (that is, for the operations and procedures for archiving).
Electronic archives: Facilities and systems provided to maintain electronic records as required by the Principles of GLP.
Electronic record: All original laboratory records and documentation, including data directly entered into a computer through an instrument interface, which are the results of original observations and activities in a study and which are necessary for the reconstruction and evaluation of the report of that study.
Metadata: Data that describe the attributes of other data. Most commonly, these are data that describe the structure, data elements, interrelationships, and other characteristics of electronic records.
Migration: The transfer of electronic records from one format, media, or computerized system to another.
System owner: The manager, or designee, of the department that is most impacted by, or is the primary user of, the system.
The guidance looks at archiving both in paper and electronic forms; although from many of the definitions here, you can see that the main thrust is toward electronic archiving, and it is this topic that I want to focus on in this column.
Roles and Responsibilities