In November, 2007, ValGenesis, the maker of the ValGenesis Validation Management and Tracking System, provided Validationcenter.com with an online demonstration of the latest version of their application. This review summarizes some of the features of the system with utility for Computer System Validation.
Warning letter citing failure to provide FDA with records from complaint database.
Warning letter citation noting inadequate software validation documentation for a medical device.
Warning Letter citation noting multiple validation deficiencies, including training, operating procedures, data migration issues, and system defects.
This form contains the criticality and complexity risk assessment for systems and major functions.
Students in the Praxis Computer Systems Validation Boot Camp use this Issue Log exercise during the course.
Students in the Praxis Computer Systems Validation Boot Camp complete the week by preparing an informational Powerpoint about their learning experience. The presentation focuses on what was covered and presents specific recommendations for implementation at the student's company.
This OQ/PQ Validation Protocol template is used to document the system's ability to meet the functional requirements specifications.
Template sections include:
Warning Letter requesting details of the configuration, qualification approach, and procedures for a system referenced in an earlier audit response.
This SOP defines the procedures and controls for managing the standard operating procedures (SOPs) for computerized systems used in regulated activities. Topics include SOP preparation, SOP approval, periodic SOP review, SOP access, SOP retention, and training. An SOP Change Request form is included with this SOP.
