SOP for Annual Maintenance Computer Systems

The Computer System Maintenance and Operation Procedure. It is the policy of XYZ Pharmaceuticals Limited that the written procedure shall be followed for the Computer System Maintenance and Operation.

What are computer maintenance and troubleshooting? This procedure is to be applied at the time of Computer System Maintenance and Operation.

RESPONSIBILITY & ACCOUNTABILITY

Persons along with their responsibilities and accountability are given below:

To prepare SOP and follow the same: - Executive - Corporate Quality Assurance, IT Manager: - To prepare SOP and follow the same 

5.0 PROCEDURE

5.1 DEFINITIONS

5.1.1 cGxP - This is a general term that applies to the following agency-regulated areas; cGMP for current Good Manufacturing Practices, cGLP for current Good Laboratory Practices, and cGCP for current Good Clinical Practices.

5.1.2 System Manager: Individual with responsibility for a specific project or application within Barr Laboratories, Incorporated. This individual may or may not have a Barr title of Manager.

5.2 System Manager or Designate Responsibilities

Maintenance of computer hardware and software

Computer System Networks, Hardware, and Software Maintenance: A System Maintenance Form should be completed for each maintenance procedure performed. In addition, this form should be completed for each IT Change Control and Change Control performed. The following information should be supplied on this form:

5.2.1 The date maintenance was performed.

5.2.2 A description of the component checked including any relevant details to describe the maintenance performed.

5.2.3 The IT Change Control and or Change Control numbers (if applicable)

5.2.4 The signature of the person performing the maintenance procedure. If not XYZ Pharmaceuticals Limited, including employees, also includes the person's company affiliation.

5.2.5 Results of the maintenance procedure should be entered in the "Results" column.

5.2.6 The "Comments" column should include any appropriate observations or occurrences observed during the maintenance procedure.

5.2.7 Error Log Maintenance: For some systems, system-generated error logs help to analyze system errors, and are a record of error conditions flagged by the system. These logs should be online for troubleshooting where applicable.

5.2.8 System Reboot: Reboot of the Computer System may be necessary as a part of preventive maintenance. This should be performed according to the schedule defined in the "Computer System Guidelines" for each computer system. A log should be maintained for each reboot.

5.2.9 "System and Data" Disk Space: The System Manager or designate is responsible for monitoring disk space. When deemed necessary, by "Computer System Guidelines" the System Manager or designate may delete files to free space on disk. The System Manager or designate should analyze the data to be deleted and ensure that it can be safely deleted. Any application data should be backed up prior to the deletion. A log should be maintained for this activity using Reference-107.

5.2.10 Performance Check/Monitoring: Perform these functions as described in the "Computer System Guidelines" for each computer system:

5.2.11 Check system clock - Monitoring and adjusting of the system's internal clock should be performed periodically.

5.2.12 Check disk devices, Clean the tape drives with cleaning tape at least once a month. A log should be maintained for this activity.

5.2.13 UPS should be checked once annually and a log should be maintained for this activity. If additional preventive maintenance is required, the procedure and schedules should be described in the "Computer System Guidelines" for that Computer System.

5.3 DOCUMENTATION

All System Maintenance Forms generated should be maintained in the "Computer System Operations" binder for the system.

5.4 OPERATIONS

Computer systems should be operated according to system operating manuals provided by the vendors, or in-house procedures and guidelines.

6.0  ABBREVIATIONS

XYZ:   XYZ Pharmaceuticals Limited

CQA:   Corporate Quality Assurance

SOP:   Standard Operating Procedure

cGLP:   current Good Laboratory Practices

cGMP:   current Good Clinical Practices

cGMP:   current Good Manufacturing Practices

IT:   Information Technology

>Good documentation Practices in pharma