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At a typical laboratory assessment the quality assurance handbook and the electronic data processing procedures are examined in order to ensure that:

  • The computer system meets the quality properties which the laboratory must or wants to fulfil.
  • The computer system is described in the quality system to the extent necessary and sufficient.
  • The responsibilities are properly defined for leaders, administrators, technicians, and users.
  • Daily operations and routines are described precisely and unambiguously in the procedures, e.g. that:
    • Backup must be frequently verified by proper restore to be valuable.
    • Virus protection is safe only if the Internet is treated with great care.
    • Access control also applies to external personnel doing servicing and repair.
    • Software errors are inevitable and require procedures for action and repair.
  • Electronic records & electronic signatures meet requirements and expectations.
  • All software in use are validated to the extent necessary and sufficient.

Beyond making it easier to meet the QA-standard, the laboratory may benefit from the advises I provide about improvements and rationalization of various procedures. Quality is a competitive advantage and quality is not just reserved accredited and certified laboratories - any company that wants quality can get it.


Copyright © 2003  Carl Erik Torp. All rights reserved.
Last updated: 20. februar 2022.