Equipment Qualification is used as an umbrella term covering the steps that ensure an instrument or equipment is appropriate for its intended use.

Qualification involves testing the equipment to demonstrate that it does what it is supposed to do. A system and/or equipment must be qualified to operate in a validated process.

The requirements for validation/qualification are now explicitly stated in both the US and European Regulations (US Code of Federal Regulations US CFR Part 211,subpart L, 211.220 and 211.222 and within the EU ‘Rules

Governing Medicinal Products in The European Community’ VoI IV, Part 5.21, 5.22, 5.23, 5.24).

Kneat can assist companies to design procedures that comply with regulatory requirements and our system will control the process ensuing a high degree of standardization and harmonization throughout the organization thus ensuing that the correct levels of testing is performed on a consistent basis.

Equipment qualification involves documenting the entire qualification process in the validation lifecycle, even after the initial qualification each piece of equipment needs to be maintained within the qualified state by ensuring robust periodic review cycles.

Most equipment qualification projects involve the following activities:

  • Validation Master Plan
  • Risk Based Impact Assessment
  • User Requirement Specification
  • Risk Assessment
  • Design Qualification
  • FAT or Factory Acceptance Test
  • SAT or Site Acceptance Test
  • IQ or Installation Qualification
  • OQ or Operational Qualification
  • PQ or Performance Qualification
  • Equipment Re-Qualification
  • Change  Control
  • Calibration
  • Preventative Maintenance Program
  • Standard Operating Procedures (SOP’s)