Validation Services
The Validation Master Plan
The Validation Master Plan is a document that describes how and when the validation program will be executed in a facility. Even though it is not mandatory, it is the document that outlines the principles involved in the qualification of a facility, defines the areas and systems to be validated and provides a written program for achieving and maintaining a qualified facility with validated processes. It is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. The regulations also set out an expectation that the different parts of the production process are well defined and controlled, such that the results of that production will not substantially change over time.
“We verify that the equipment does what the manufacturer says it will do!”
In order to prove that a piece of equipment is performing consistently, we perform IOPQ testing. These initials stand for: Installation Qualification (IQ): This verifies that the unit is installed properly. We will check voltage, proper leveling, etc. We do not install the equipment as part of the IQ. Operational Qualification (OQ): This is when we test all of the features of a unit such as the control panel, any on and off switches, alarms and 24-hour mapping for temperature units. For non-temperature units we test other features like rotation for centrifuges, pH units for pH meters, and weighing accuracies for balances. Performance Qualification (PQ): This is what we test to ensure that the unit operates as the customer requires it to work. This is customer specific and will require our team working with yours to define the scope of work.
We have decades of industry experience in the fields of validation, calibration and analytical instrumentation. We are focused on a partnership with our customers to enhance the customer experience. Our expertise is vast including expertise for small jobs with a single piece of equipment or large scale remediation project with hundreds of instruments.
Book our Calibration Services
If you would like a quote or further information about our SLAB Calibration Services, please click here to contact us and arrange an appointment. We look forward to being of assistance.