Validation team responsibilities

Validation is a team effort that generally requires the involvement and close interaction of Quality Assurance, Production, Packaging, and Maintenance with other appropriate support such as Product Development and Quality Control. The validation team should include representatives from the above-mentioned departments to provide the necessary expertise and guidance. 

Head of validation Head of quality assurance Validation representatives Validation representative  

Person appointed by the validation team Qualification/validation teams  

Personnel from different manufacturing areas. The size of the teams varies with the scope of the activities necessary. Personnel from external validation services may be included. 

External qualified personnel who support the qualification/validation teams if necessary. 

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Project description What is a Validation Master Plan Scope of Validation Master Plan Definition for the term validation Validation team member Validation team responsibility Concept of qualification/validation Fundamentals... 

It is the responsibility of validation team members to foffow the procedures. The quality assurance (QA) manager is responsibfe for SOP compliance. 

It is the responsibility of the validation team to understand and implement the terms defined in the validation lexicon. The QA manager is responsible for the SOP compliance. 

To describe the functions and responsibilities of the validation team to meet the cGMP compliance... 

The validation team is responsible for following the procedure. The quality assurance manager is responsible for SOP compliance. 

Validation Team A well-defined validation team with a well-written description of responsibilities is required and assures the adequate realization of the validation tasks. A validation team should be composed by different responsibilities responsible-of-validation team, team leader, archive manager, test coordinator, quality assurance member, tester, and witness. The responsible-for-validation team elaborates and approves the VMP, protocols, and reports. The team leader should be responsible for the computer system validation and utilization. An archive manager is responsible for the management of all computer system validation documents. The test coordinator is responsible for the computer system test and coordinates the elaboration and operation of tests for evaluating the performance of the computer system. A quality assurance member is required to periodically inspect and train the personnel and review all the validation documents. The tester is responsible for the execution of the tests required to perform the validation protocol. The witness is responsible for observing and reviewing the operations of the tester. 

For each system validation project the validation team must be identified and would typically consist of designated personnel (normally identified by job function at this stage) that will be responsible for the provision, review, and approval of all validation documents and implementation of the qualification testing. 

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