Computer System Validation Sop Template

To lay down the procedure for computer system validation.

Computer system validation sop template. Validation at the site is performed in accordance with the therapeutic goods administration tga code of gmp pics guide to gmp for medicinal products pe009. Clinical trial computer system validation the purpose of this sop is to describe the clinical trial computer systems processes used in clinical trials sponsored by kings health partner organisations for the capture processing analysis and reporting of clinical trial data within the partner institutions. Validation in accordance with good manufacturing practice gmp principles forms a key strategy in this commitment. The validation process envisaged by this sop is prospective and encompasses the entire life of the computerised system from initiation onwards.

13 to demonstrate computer systems are fit for purpose particularly those that impact on the quality of the trial data and subject safety the sponsor must ensure the validation integrity and security of the data. Basic package of 12 software validation templates and a computer system validation sops. The trace matrix is a deliverable produced during computer system validation to provide verification of that all user requirements have enabling functional requirements and the both user and functional requirements have been adequately tested in the validation testing protocols. This complete package of 38 computer system validation templates and software quality assurance sops is available for 960.

This computer system validation sop addresses the fda requirement that computer systems be validated in a consistent and rigorous manner to ensure quality reliability and conformance with regulatory requirements. Examples of systems include. Validation strategy and verification activities depend on the software category maturity as implied in user base and complexity. System uses electronic signatures.

The periodic validation review pvr report template sop is used to document the assessment of a systems current validation state and plan for closure of any gaps. 20 scope 21 this sop shall be applicable for all software controlled instruments in the quality control department. Validation checklist the following is a checklist of step by step recommendations for performing computer system validation. Topics addressed within this sop include standard validation.

It includes many activities in common with other.