Validation planning is an essential process in quality assurance, where it is verified that a system or product meets the established requirements. To achieve this, specific tests and inspections are planned and documented. In addition to planning, a risk analysis is often necessary to identify potential weaknesses and develop targeted validation measures to mitigate risks.
In many industries, particularly in pharmaceuticals, medical, and food industries, compliance with regulatory requirements drives validation planning. It is crucial that all tests and inspections comply with these regulations to ensure compliance. Thorough documentation of the validation process is vital to demonstrate adherence to quality requirements, especially during audits or inspections.