This presentation will provide auditors who are not knowledgeable about computer system validation with a basic understanding of the requirements and expectations for validation documentation. We will address the basic components of computer system validation, the importance of assessing the quality of such validations performed by vendors, suggested procedures for reviewing validation documentation to ensure a meaningful review in a limited period of time, and how to establish reasonable remedial actions in the case of inadequate validation documentation.
Auditing CSV materials is an important element in most audits of CROs, technical service providers (TSPs), and application hosting organizations.
Attendees should have some familiarity with performing vendor audits, as this seminar will not cover basic auditing procedures or approaches.
Auditing CSV materials is an important element in most audits of CROs, technical service providers (TSPs), and application hosting organizations.
Attendees should have some familiarity with performing vendor audits, as this seminar will not cover basic auditing procedures or approaches.
