Equipment Validation
Premier Validation consultants will help you with the design, design review, selection and installation of the equipment. Our expertise will ensure that critical parameters that impact product quality are considered during this process.
Risk Assessment
Our Risk Assessment service will:
- Identify the risks associated with the process/equipment/materials
- Assess the potential impact of failure
- Determine the likelihood of the risk
The Risk Assessment results in a matrix document that indicates the level of qualification recommended for the equipment.
This, combined with a Validation Master Plan, defines the systems and equipment to be validated, sets out the number and format of the protocols and establishes the standards for acceptance criteria.
IQ, OQ, PQ
The Risk Assessment results in a matrix document that indicates the level of qualification recommended for the equipment.
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- and Performance Qualification (PQ)
We then execute the protocols, analyse and interpret the data collected, resolve any deviations noted during the execution, and prepare final validation reports.
Qualification and Validation are integral steps in Quality by Design, building quality into any process or facility. Premier Validation has years of experience to provide an efficient, effective, documented methodologies to ensure your process efficiencies, quality and compliance global regulations and guidelines.
