Laboratory instrumentation plays a significant role in analytical testing in a modern analytical testing laboratory and it is not surprising it attracts significant scrutiny from auditors.

Auditors will usually want to review:

• Instrument SOPs
• Calibration records
• Instrument logbooks
• The laboratory’s arrangements for ensuring instruments are serviced and calibrated on schedule
• How a user can determine that a particular instrument is within its calibration due date

Under Scrutiny

Some aspects of laboratory instrumentation are currently attracting particular scrutiny, these are the integrity of data created using laboratory instruments, such as

1. Individual user accounts which are exclusively used by a single identifiable user

2. Multiple user accounts will attract observations and warning letters

3. E-signature controls, such as:

• Minimum password length
• Password complexity
• Passwords changed at frequent intervals
• Controls to detect unauthorized access attempts

4. Audit trails enabled

The integration of chromatograms is performed in a consistent manner using sound scientific principles.