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Calibrations (Accredited laboratory) Maintenance - Repairs Department of Cleanroom Validation (Lloyd's Register Certified)) IQ/OQ/PQ Temperature/ Humidity Mapping Occupational Health & Safety Measurements Validation Studies Vibration and Noise studies Laboratory OrganizationValidation Studies
The Laboratory of MAIN SOLUTIONS carries out validation studies with the scope to:
- Quantify the performance of a system
- Investigate possible malfunctions and defects
- Compare the method in use against other methods available and to record comparison results
- Declare compliance of a product or a process or a system against predefined specifications that are required by relevant standards and regulations
A validation study maybe comprised of all or part of the following:
- Repeatability study of the method
- Precision study of the method
- Application range of the validation and critical limits
- Application range of the method
- Calibration and validation of measuring equipment
During a validation study the following statistical values are calculate:
- Average value and/or intemediate
- Dispersion (standard deviation, CV%)
- Adaptation Factor R2
- Bias (deviation from the average population)
During the assessment of the results of a validation study
- The main values that were measured are analyzed together with the relevant statistical values.
- The study results are compared against the requirements of applicable Standards or Regulations and/or customer demands.
- The conformity of the system or the process is declared in compliance with regulations, standards and/or customer needs.
Equipment - Method
The standard equipment that is used for the performance of validation measurements is traceable to national or international standards.
The measurements are carried out and the statistical values are calculated according to published standard methods.
The declarations of conformity take into account the national legislation and the European Norms as well as the requirements of the international certification bodies.