Computer Operations Manual SOP

Title Version Status Date Page 1.0 Commercial in Confidence 08-Aug-2006 1 of 6

Document No: SOP_0108 Prepared by: David Brown Date: 09-Aug-2006 Version: Title Version Status Date Page 1.0 Commercial in Confidence 08-Aug-2006 2 of 6

Document Approval

Name Role Date Signature David Brown Author

Document Control

Version Author Date Description 1.0 David Brown 08-Aug-2006 Version 1 Title Version Status Date Page 1.0 Commercial in Confidence 08-Aug-2006 3 of 6

Table of Contents

1 Introduction...... 4 1.1 Purpose...... 4 1.2 Scope...... 4 1.3 Definitions...... 4 1.4 Responsibility...... 4 1.5 References...... 4 2 Procedure...... 4 2.1 Format...... 5 2.2 Usability...... 5 2.3 Distribution...... 5 2.4 Audience...... 5 2.5 Organization...... 5 2.6 Operator Instructions...... 5 2.7 Scheduling...... 6 2.8 Backup and Restore...... 6 2.9 Archive and Retrieval...... 6 2.10 Messages and Codes...... 6 2.11 Reference Manual(s)...... 6 Title Version Status Date Page 1.0 Commercial in Confidence 08-Aug-2006 4 of 6

1 Introduction

1.1 Purpose To provide the requirements for client operations documentation for validated computer systems.

1.2 Scope Department/Section: IT Group The Computer Operations Manual provides instructions, in the form of procedures (i.e., backup, restore, or batch processing), for operating the respective computer application effectively.

1.3 Definitions IT Group – the group responsible for development, operation, and maintenance of computer systems.

1.4 Responsibility The responsibility for preparation and approval of the Computer Operations Manual are defined in SOP SOP_0100 "Implementation Life Cycle". It is the responsibility of management of Information Technology and Validation to ensure that this procedure is followed.

1.5 References

Document ID Title SOP_0100 Implementation Lifecycle SOP SOP_0102 Document Standards SOP SOP_0109 Backup and Archival SOP

2 Procedure Prepare the Computer Operations Manual for the system in a style that allows the document to be used as on-line help and to serve as a training tool. Title Version Status Date Page 1.0 Commercial in Confidence 08-Aug-2006 5 of 6

2.1 Format The Client Operation Manual will be prepared according to the general format requirements defined in SOP SOP_0102 "Documentation Standards". For vendor supplied documentation which does not conform to SOP SOP_0102 "Documentation Standards", replacement pages must include version number and version date.

2.2 Usability Information in the Computer Operations Manual shall be presented in terms that are meaningful to the Computer Operators. The documentation shall be prepared for the Computer Operators specifically and shall not be based on a standard system or version of the system that is different than the delivered system. It is intended that the Computer Operations Manual be written for a specific platform with sections amended as each application is developed.

2.3 Distribution Information Technology is responsible for maintaining and distributing the Computer Operations Manual.

2.4 Audience A description of the staff positions or departments responsible for operating various functions of the system.

2.5 Organization A description of how the Computer Operations Manual is organized. For example, the Computer Operations Manual may have multiple volumes, quick reference guides, or vendor supplied volumes.

2.6 Operator Instructions Application operations such as changing control files or accessing security, system date, or job scheduling should be described and explained in sufficient detail to allow the Computer Operator to fully perform that operation. Include for each operation as appropriate: . Screen representations; . Description/definition of required input; Title Version Status Date Page 1.0 Commercial in Confidence 08-Aug-2006 6 of 6

. Report representations; . Output (screens and reports) resulting from respective input; . Related messages and codes; . Error resolution procedures, and; . How to activate help functions.

2.7 Scheduling The activities required to perform computer operation scheduling must be defined in this section. They include, but are not limited to: . Job Scheduling; . Job Dependencies, and; . Application Availability Requirement.

2.8 Backup and Restore Describe any backup and restore procedures not described in SOP SOP_0109 "Backup and Archival".

2.9 Archive and Retrieval Describe any application specific archive and retrieval procedures and schedules including any retention schedules for data tapes.

2.10 Messages and Codes The Computer Operations Manual should include all application error messages/codes (e.g., data exceptions, invalid/incomplete data) and a description of the associated problem. The appropriate error resolution procedure should be described. This section should also describe how to obtain further assistance.

2.11 Reference Manual(s) Identify external material used in support of the applications (e.g., client operations manual, operating system manuals, database manuals).