Computer System Validation White Paper

1. Introduction For the past 20 years or so the term validation or more precisely computer system validation has been used in the pharmaceutical industry. The American health authorities (FDA) provoked intense discussion and uncertainty first in the USA and later in European countries. Today it is generally understood what basic requirements are involved in the validation of a computer system. Nevertheless, opinions differ greatly with regard to the extent and scope of the activities required. Standard regulations such as GMP or GAMP do indeed provide general principles which also apply to validation, however, these can only answer questions in part. Greifensee, Zurich, September 15, 2010 /Washington Bangla Radio / India PRwire/ -- Practice provides the answer to the remaining questions. Through the variety of and successful validations of computer systems pharmaceutical companies have created accepted procedures for the validation of computer systems in a regulated environment. Over time pointers have emerged, which are accepted by government agencies and considered standard practice. This document is intended to provide the reader with an overview of the issues and topics associated with computer system validation in general and specifically in reference to system solutions from METTLER TOLEDO. The document shows and describes the steps required in a validation project and helps to clarify the subject matter. The steps required for the validation of a computer-assisted system can vary from system to system. For this reason, the procedure described in this document must not be considered as the only valid standard. This suggested procedure is intended as a pointer and must be adapted to customer requirements in each project. 1. The term "validation" The word "validate" is defined in the dictionary as "to make valid", "to legalize" or indeed "to confirm". But what does this mean exactly? Through validation there is documented evidence that a process or a system meets the previously specified requirements in a practical application. Validation is not a random or imprecise process. It is a scientific method for confirming the value of a system for a specific purpose. The use of the word in connection with computers originated in the USA. The term "validation", as used in the USA, refers to any type of evidence about a state of affairs. "Validated" is therefore not an adjective for an object, but rather an adjective for a property of an object. A. The demarcation with qualification The terms validation and qualification are very often used interchangeably. The precise meaning of and the difference between the terms is discussed more in theory than in practical usage. Because a clear distinction is only possible in theory, the line between qualification and validation is indeed blurred. However, as already shown in practice, a clear distinction is not necessarily required. For completeness the terms are explained briefly below. The following definitions of the terms have been established as a type of standard. Hardware and devices are qualified. Methods and processes are validated. The combination of qualified hardware and validated processes and methods results in a validated system. METTLER TOLEDO specializes in the area of precision instruments for professional use. METTLER TOLEDO laboratory instruments are used in research, scientific, drug discovery, and quality control labs, amongst many others in the pharmaceutical, chemical, food and cosmetics industries. METTLER TOLEDO comprehensive industrial solutions cover the various steps in a host of manufacturing processes at many of the same customers that laboratory serves. Solutions range from receiving raw materials through various manufacturing processes, in-line process control and end-of-line packaging control, to logistics and shipping. Increasingly, these solutions are fully integrated into the customer's IT environment, helping automate their workflows. In food retail, our offering for fresh food management ranges from receiving and pre-packaging, to in-store solutions for self-service departments, deli counters, and checkout terminals. -