To answer the questions about storage of electronic records, there are two common ways to approach this (apart from deleting
them, of course). The first is the BAD (buy another disk) approach and keep the records on line for as long as you need them
— or need another disk. The second is to archive them and keep them near line or off-line. Regulations offer little or no
help — they just say how long you have to keep them. So what are we going to do?
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
Ok, so who is involved and what do they do in this archiving process? The guidance document outlines several roles and responsibilities,
such as test facility management, study director, quality assurance (QA), information technology (IT), and the archivist.
I want to focus on just two for the purposes of this discussion: the archivist and IT. If you work in a GMP-regulated laboratory,
you can interpret "archivist" as either QA or the laboratory.