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.
This OQ/PQ Validaiton 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.
The purpose of this validation template is to provide a concise and compliant method for documenting the validation elements of spreadsheets. This template would also be suitable for documenting the validation of other small configuration projects, such as queries, reports, and calculations.
Sections in the spreadsheet validation template include:
This form contains the severity and complexity risk assessment for systems and major functions.
In September, 2009, PIC/S published a new version of their guide for GMP-inspectors to use during inspections of pharmaceutical manufacturing facilities. The annexes provide additional information that is generally applicable for both finished medicinal products and actives substances.
See section 11 for specifics on computerized systems.
Students in the Praxis Computer Systems Validation Boot Camp use this Issue Log exercise during the course.
