Operational Qualification and Accreditation
Packaging Qualification Principle
The packaging qualification is documented testing that demonstrates with a high degree of assurance that a specific system will meet pre-determined acceptance criteria (type of use, temperature and duration).Qualification Process
In order to meet the high level of quality requirements expected from the healthcare community, the Kalibox qualification process follows a rigorous methodology.
The qualification protocol is the reference document for the realisation of the tests. It must be validated by both parties and define:
- The objective of the qualification, reference regulatory documents and responsibilities
- Operating conditions and testing procedures
- Acceptance criteria
The Qualification report includes tests results and the calibration certificates of used equipment. The Qualification report aims at providing the comprehensive documentation to support your Quality Assurance system and at explaining the testing methodology.