Validation Program Organization

Many groups, both within and outside the organization, support the validation of computer systems. It is the responsibility of Executive Management to provide adequate resources to support the achievement of compliance in the computer systems validation 

Responsibilities are often similar across multiple functional groups such as Information Technology, Engineering, Laboratories (QA/R D), Clinical Research, Manufacturing/ Operations, contract developers, and computer technology suppliers. 

In order to manage the execution and supervision of computer systems validation activities, there needs to be an organizational structure established. This chapter suggests an organizational structure for supporting to a computer validation program. 

The Computer Systems Validation (CSV) Executive Committee is composed of Validation, Compliance, Regulatory Affairs, and Information Technology senior management. Another possible member of this committee is a Process Innovator. 

The members and their deputies are assigned by the CSV Executive Committee. For ad hoc activities, the team can be complemented with representatives from departments performing activities that support computer validation. Examples of such departments are Purchasing, IT, QA Validation, QA Compliance, Operations, R D, Engineering, and representatives from each manufacturing facility concerned. 

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During the last 10 years it has been attempted to develop in vitro methods as alternative methods in the study of effects where animal models have previously been necessary. Such effects include skin and eye irritation and specific organ damage. Validation programs have been launched, and some of the above-mentioned methods have been sufficiently validated for use in regulatory risk assessment of chemical substances and may now for certain purposes be used as stand-alone evidence. Results from nonvahdated methods can in some cases be used as supportive evidence to human and animal data. 

Computer system register Validation evaluation and rationale Validation program priorities Justification for nonvalidated systems Validation organization/responsibilities Validation training... 

As part of the supply contract each supplier or subcontractor needs to provide a corresponding project and quality plan to identify and outline the procedures, standards, organization, and resources to be used to align with the requirements of the pharmaceutical manufacturer s project. The contractors and suppliers involved with GMP work should reference the project validation plan and identify the specific requirements that are to be addressed to ensure the appropriate level of documentation in support of the pharmaceutical manufacturer s validation program. 

Chapter 6 suggests an organization structure supporting the computer validation program. 

The validation life cycle provides several advantages over prior methods for the organization of validation programs. The cohesiveness of an organization s validation efforts when the life-cycle approach is utilized as an operational model is unattainable in other operating modes. 

The ruggedness of an analytical method is the absence of undue adverse influence on its reliability of performance by minor changes in the laboratory environment [43]. This validation parameter is not recognized by all organizations with testing oversight, as this characteristic is implied by collaborative validation programs (see Section IV.D). 

The VP defines the scope, organization, and timetable of the validation program. Snpplier organizations may not be known at this stage and may be generically identified within the VP. 

Abstract In an effort to assess the method validation done using ICP-AES in our laboratory for potable water, an Environmental Laboratory Approval Program organized by New York State Department of Health, Wadsworth Center providing the reference material has been undertaken for 14 trace elements and seven other chemical constituents. The certified means for the reference material and the results obtained in our laboratory are compared. The comparisons helped us assess the quality of our work. All the data from the inductively coupled plasma atomic emission spectrometer (ICP-AES) fall into the ranges specified. 

Numerous radon and radon decay measurements in houses are now being made by a large number of private and governmental organizations. In order to assure valid and consistent measurements, it is important that proven methods be used following standardized procedures. To address this need, EPA issued "Interim Indoor Radon and Radon Decay Product Measurement Protocols" and established a Radon/Radon Progeny Measurement Proficiency program. 

And finally, I add, my program is a whole lot more than just a spreadsheet. To use it as such is to play Chopsticks upon the mighty organ of a grand cathedral to ask Sean Connery to advertise socks. In other words, the spec from my point of view is partial, expressing the requirements of only one class of user so the implementation classes you see here are chosen to suit a much broader scheme. Nevertheless, it is able to function merely as a spreadsheet when required, and I wish it to be validated as such against the spec.4... 

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