Equipment Validation Training
We can train your personnel and give them the tools to validate equipment. The areas of study will encompass the following:
Risk Assessment
Our Risk Assessment guidance will:
- Identify the risks associated with the process/equipment/materials
- Determine the likelihood of the risk
- Assess the potential impact of failure
The Risk Assessment results in a matrix document that indicates the level of qualification recommended for the equipment.
The benefits of a Risk Assessment combined with a Validation Master Plan include:
- defines the systems and equipment to be validated
- sets out the number and format of the protocols
- establishes the standards for acceptance criteria.
Design Reviews of Facilities and Equipment
- design
- design review
- selection of equipment
- installation of the equipment
Qualifications
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
You can 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.
Cleaning Validation of CIP Systems and Laboratory Equipment Validation
- Essential validation of CIP systems and laboratory equipment.
Need advice on the validation of CIP systems, please give us a call.
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