Quality Assurance in Instrumentation 27

Table 1. continued

Documentation

l!'l
l!'l

1nstrument sticker
Operating procedures and schedules for preventative maintenance, calibration. and performance verification and procedures for error
handling

l!'l Notebook and/or logbook entries

On-going performance control (performance qualification, system suitability testing, analytical quality control) for routine
analysis

•
•
Dornmentation

· Combi ne instnunentation with analytical methods, columns. reference material into an analysis system suitable to run the
unknown samples
Define type and frequency of system suitability tests and/or anal ytical quality control (AQC) checks Perform the tests as
described above and document results
Develop procedures for definition of raw data and verification of raw data and processed data (for GLP/GMP)

•
Test protocols
Data sheets with acceptance criteria for system performance test results
System performance test documents
Quality control charts
SOPs for definition of raw data and verification of processed data (for GLP/GMP)

Table 2. Form for computer system identification Computer hardware

Manufacturer Model
Serial number Processor Coprocessor Memory (RAM) Graphics adapter Video memory
Mouse
Hard-disk Installed d1ives
Space requirement Printer
Manufacturer Model
Serial number Space requirement
Operating software
Operating system (version) User interface (version)
Application software Description
Product number (version)
Required disk space

fluorescent lamps or by motors can interfere with the transmitted data.

The installation should end with the generation and sign off of the installation report, in pharma­ ceutical
manufacturing referred to as the Installa­ tion Qualification (IQ) document. It is rec­ ommended to follow
documented procedures with checklists for installation and to use pre-printed forms for the installation report.
When the installation procedure is finished the hardware and software should be well documented with
model, serial. and revision numbers.

•
 For larger laboratories with lots of equipment this should be preferably a computer based data base
(Table 2). Entries for each instruments should include:

In-house identification number Name of the item of equipment

The manufacturers name, address, and phone number for service calls. service contract number, if there is
any
Serial number and fim1ware revision number of equipment
Software with product and revision number
Date received
Date placed in service Current location
Size, weight
Condition, when received, for example. new, used. reconditioned List with authorized users and responsible
person

It is recommended to make copies of all important documentation: one should be placed close to the
instrument, the other one should be kept in a safe place. A sticker should be put on the instrument with
information on the instrument's serial number and the companies asset number.

2.3.4. Logbook

A bound logbook should be prepared for each instrument in which operators and service techni­ cians
record all equipment related activities in a chronological order. Information in the logbook may include: