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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. |
