The procedure addressing the selection and installation of laboratory equipment will also need to provide instructions on how to document instructions for performing an equipment installation and how to record the installation. The following outline is for a combined set of installation instructions and records
1. Purpose: Record the purpose of the document
2. Scope: Define what is covered and what is not covered by the document.
3. Responsibilities: Define who is responsible for doing what
4. Identification of Personnel Involved: Table the following information:
ii. Job Title
v. Signatures and initials.
5. Documentation of the Site of Installation Record the following information:
i. Room No. / Bench No.
ii. Required Bench/Floor Area
iii. Available Bench/Floor Area
i. Record the required number of power sockets and total current requirement
ii. Record available circuit numbers, number of available sockets, circuit rating, current load, and available current
i. Record the required number of network sockets
ii. Record the reference numbers of the available sockets and socket(s) record
6. Reconciliation of Deliveries
i. Record and check the part number(s) of each item match the part number on the Purchase Order and supplier’s Delivery Note
ii. Record and check the serial number(s) on each item agree with the serial number on the supplier’s Delivery Note
iii. Inspect each item for damage and record condition
iv. Inspect any tilt indicators, confirm they are all present and intact and do not show the package has been tilted
7. Reconciliation of software, documentation, cables, manuals, spare parts, and consumables. Compile a list of all items together with respective part numbers and document presence and are undamaged.
8. Documentation of the Equipment Record the following information:
ii. Actual part number
iii. Serial number
iv. Firmware version
v. Laboratory asset number of the hardware components
9. Documentation of computer hardware
i. Record the following information relating to the computer and monitor:
c. serial number
d. laboratory instrument No.
ii. Record the following information
a. Actual processor type and speed
b. RAM type and size
c. Graphics adaptor type
d. Hard disk size and partitions
e. LAN Interface model identity
f. Pointing device
g. Optical drive type
Determine that the components conform to specifications established in the design qualification
10. Installation, configuration, and documentation of software This section is used to record the configuration of the software, including:
i. User accounts
ii. Electronic signatures (format)
iii. Passwords (password expiry and complexity requirements)
11. A list of all installed software Record the following information about each software package included: -
ii. Software name
iii. Version No.
v. Licence No.
vi. Activation code
12. Clock Configuration Provide instructions on how to configure the computer clock and record the following information.
i. Time Zone
ii. Daylight saving (Yes/No)
iii. Time server address
13. Installation Testing Provide instructions on how to test the equipment has been correctly installed. Including testing of:
i. Key equipment functions
iii. Security features
iv. Audit trail features
14. Equipment Logbook
Confirm an equipment Logbook has been issued and record the logbook number (if applicable) and date of issue.
15. QMS Procedures
Record QMS procedure(s) number(s) and Title(s)
16. Routine Preventative Maintenance (PM) and Calibration
Record Calibration and Preventative Maintenance (PM) has been scheduled, and any contracts have been established.
Record all training necessary to use the new equipment