Validation team

Software and computer systems that are subject to validation must be designed using strict procedures with sufficient documentation. During the process of system design, strict controls must be in place to allow future validation success. The system designer must ensure that documentation of the system meets minimum requirements necessary to satisfy the needs of the validation team. 

Together, the defined/written series of tasks, test methods, requirements and docnmentation required to carry out the validation procedure for a system can be described as the validation protocol. The instrnc-tion mannal for all of this is the validation plan, developed by the validation team. 

If it has not been already completed, the first recommended task is to establish/designate a validation team within the company—perhaps one snch team at each of mnltiple sites. If one elects to have a separate team at mnltiple sites, these teams mnst make certain that they carry ont the validation processes consistently across all sites. In larger corporations, this is often accomplished via a central validation committee managing the individnal gronps at the varions sites. For smaller companies a team may consist of only one individual. The goal of the team(s)/committee is to draft comprehensive validation plans and protocols across all the instrnments, systems and processes that reqnire validation. They must then diligently execnte, document and verify each validation procedure. 

As a part of risk assessment, each validation team should be well versed with the suggestions and stipulations provided in the FDA s Title... 

The report should also establish the credentials of the validating team. 

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. 

Perform calibration requirements identified in the manual or established by the validation team. 

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