Validation

Validation means establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. The Major Phases of validation include Pre validation, Process Validation and Validation maintenance Phase.

Cleaning validation is documented proof that one can consistently and effectively clean a system or equipment items. Analytical procedure validation is to demonstrate that it is suitable for its intended purpose. An important element of successful HVAC validation is prevalidation design work. Change control within quality management systems (QMS) is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without introducing faults into the system. In Computer system validation (CSV), validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules.

  • Cleaning validation and process validation of biopharmaceuticals
  • Analytical method validation and computer system validation
  • Change control
  • Phases of validation
  • HVAC system validation

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