I'm assuming that either the spectrometer is networked or the system operates in a standalone mode and the records that are produced are transferred to a network drive for backup and recovery. End-users are responsible for backup and recovery because it is their system and their data. These facts often are overlooked when a backup schedule is developed. Responsibility often can be abrogated and a default schedule given that is not appropriate to the system or the data held on it. Users must be aware that this is their responsibility and that they are accountable, even though the work is carried out by a third party. Some of the user responsibilities:

• Define the data criticality
• Define the type of backup required: full only, full and incremental or full and differential (as outlined in Part IX of this series)
• Define the speed of any data or application recovery in the event of failure

The IT department will carry out the backup and recovery of data on behalf of the end users. The schedule for the backups will be worked out in discussions with the end users and this should be recorded in a service level agreement (SLA) that outlines the roles and responsibilities of all parties and the schedule. IT will also need to have a procedure that covers:

• What to backup
• How to backup
• How to recover records and the application
• Defining the interface between the laboratory and the IT department

Table I. Combined process flow and task description

There is a third role that will be involved in the process: quality assurance. QA will be involved in authorizing the SOP as well as checking that any work described in the procedure has been carried out correctly via a periodic audit.

Defining the Backup Procedure The procedure for performing a backup should be defined in sufficient detail to ensure that any trained person undertaking a backup can repeat the task. How this is to be achieved depends upon your company's approach to writing a procedure. This can be accomplished through one or a combination of the following ways:

• Text
• Number paragraphs
• Flow chart and text

Figure 1. High level procedure for backup of a spectroscopy application and data.

From a personal viewpoint, I prefer a flow chart and text as this gives a better understanding of the procedure. At the simplest it can be a flow chart that outlines the main points in the procedure plus a textual description of each step. Figure 1 shows a high level procedural flow chart for a backup of a system.

This process flow can be linked to the text by referring to the number in the individual stages of the process. A better approach is to link the two together in a table so that the process flow and work instructions side by side with little room for misinterpretation as shown in Table I. In this approach the process flow and the work instruction are easily and visually linked for easy of interpretation. If further required, any role involved in the process also can be added to the table as a separate column to clearly identify the role with the work instruction.

Defining the Recovery Procedure The recovery process also needs to be documented in a similar way to the backup process has been described. Therefore if you use the text or process based approach for the backup this must be mirrored in this section for the recovery process.