Qualification of Equipment

Describes responsibilities and procedures to –

• Write specifications.
• Qualification of the vendor.
• Installation.
• Development.
• Contents of system inventory.
• Testing prior to use (operational qualification) and for on-going testing (performance qualification).

The SOP also includes four attachments with templates for easy implementation.

Purpose:

Documented qualification of equipment throughout the entire cycle: comparing user specification with vendor specification, vendor qualification, installation, initial and ongoing testing. If there is a specific reason, alternative scientifically based approaches may be used. The use of alternative approaches should be justified, documented and approved and should comply with applicable GxP regulations and company standards.

Scope:

Equipment used in regulated environments.

• Laboratory Supervisor.
• Quality Assurance Department.
• Suppliers
• Business Owners