Which SOPs are needed for a computer system?

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How many SOPs you’ll need will depend on the complexity of the system and also how your QMS has been built. SOPs will need to cover some of the items on the list below, and may also need to cover other items:

SOPs in the IT department
SOPs in the IT department must be made, or changed to include LIMS when appropriate. An agreement for the maintenance and support of LIMS must also be created.
• Backup procedures
• Change control for items where IT is responsible (hardware, operating system, database management, network, installation of LIMS versions)
• Configuration management outside of LIMS (operating system, database, LIMS program files, network, hardware)
• Security and user access outside of LIMS

SOPs for LIMS key persons
• Responsibilities for LIMS (IT, LIMS system managers and key persons, LIMS steering committee, users, QA)
• User training and user access inside LIMS
• Security
• Building static data / templates in LIMS incl. Nomenclature, etc.
• Instrument connections to LIMS
• Connection LIMS-other IT systems (MRP, Document management system, Chromatography Data Systems, other instrument systems)
• Error handling
• Change Control
• Validation / revalidation / qualification of LIMS itself, connection to other systems and instruments, and static data
• Configuration management inside LIMS (static data)
• Disaster recovery
• Long time storage of old data outside of LIMS
• Retirement of LIMS (yes, it is required!)

SOPs for LIMS End users
• Daily use of LIMS, with reference to other LIMS SOPs

Other SOPs
• Each department where LIMS will be taken into use will have to assess all existing SOPs to see if the need to be changed due to the implementation of LIMS.

Logs (documentation that SOPs have been followed)
• Several SOPs will require documentation that they have been followed. In many cases this is a log, but it does not matter if it is electronic or a book, as long as there are procedures in place to make sure it works.

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Table 04x02