Equipment Qualification involves Installation Qualification (IQ), Operational Qualification (OQ), and in most cases Performance Qualification (PQ).
IQ consists of documented verification that the equipment/system installation adheres to approved specifications and meets design criteria. The IQ is developed from design specifications, user requirements, drawings, equipment operating manuals, and other necessary documentation.
OQ consists of the documented verification that the equipment/system operates per design criteria over the defined operating ranges and under the defined challenges. OQ includes documentation of supporting SOPs and calibration records. Examples of OQ testing include safety features and alarms, sequences of operation, uniformity studies, and equipment shutdown and recovery testing.
PQ consists of the verification that equipment/systems perform as specified during the actual process. The performance must be reliable and reproducible within a specified predetermined set of parameters.
Preparation and Execution of Validation Protocols
Validation Protocols- Quality Solutions, LLC staff are experts at creating clear and concise execution documents and summary reports. We can customize protocols to your pre-existing format or use our standard format based on industry guidelines.
Protocol Execution- Prior to execution, we verify that all applicable instrumentation on the equipment is calibrated. If the equipment is not calibrated, we can offer calibration services using the appropriate traceable standards or through a partner company.
Execution Data are collected directly on the protocol forms. Staff are trained to fill in all requested information in accordance with Good Documentation Practices. Data failing to meet acceptance criteria or producing unexpected results requires a deviation report. Deviations are addressed at the time of occurrence with direct client involvement. Our staff will provide a clear description of the deviation and recommendation for corrective action.
Post-Execution Data Review- All data are internally reviewed upon completion of field testing for adherence to the protocol acceptance criteria and Good Documentation Practices. This helps reduce the review time and streamlines the turnover process of the equipment or system from Validation to Operations, thus, helping you achieve operational efficiency.