SOPs

Purpose

Standard Operating Procedures (SOPs) may be called other names, but the purpose is to have procedures for how things shall be done.

SOPs for a computer system need to cover a number of topics. There may be one or many SOPs for the system, depending on the complexity of the system, the porganization where it is used, and the existing quality system in the organization. Some of the items are shared responsibilities between the application manager and the IT department, or between others inside or outside of the organization. The SOPs need to reflect this.

SOP

All SOPs are procedures for how things shall be done in the organization. They shall contain information on:

• WHAT the SOP aims to cover

• WHO is responsible, both for what shall be done and for updating the SOP

• HOW the procedure shall be carried out

• HOW to document what has been done

Which SOPs are needed for a computer system

• Creating new static data / templates in the system

• Validation / qualification

• Responsibilities

• Security

• User training and access to the system

• Connection between this system and others

• Long time storage of data outside of system / Off-line archiving (this is not the same as backup)

• Disaster Recovery Procedures (what to do if the instrument or the system does not work)

• Error Handling

• Change control

• Configuration management

• Daily use, maintenance

• Backup of data

• System retirement / decommissioning

Want to know more?

Publications:

Segalstad: Instrument Validation, Managing the Modern Laboratory Vol. 5 No.3 57-61

Classes:

Classes are occationally offered by Segalstad Consulting AS and the company's affiliates. They are open to whoever wants to attend.