Greifensee, Switzerland (PressExposure) September 13, 2010 -- 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.
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.
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.
rdware and devices are qualified.
Methods and processes are validated.
The combination of qualified hardware and validated processes and methods results in a validated system.
Reasons for carrying out validation Validation in a regulated environment goes beyond simply providing a piece of paper for government agencies. The process of validation is complex and involves expenditure and effort. But what are the reasons for carrying out validation? There are many reasons, but they tend to have similar origins. The main and most common reasons are listed below.
* Obtaining legal compliance for the production of drugs and complementary products. * Minimizing the risk of malfunction. This can prevent high costs associated with errors and failure. * Optimizing quality through exact and reproducible processes. * Obtaining assurance that the system meets the necessary requirements and is therefore suitable for production and quality control.
Formal and documented transfer process of the system to the system owner. Validation can be viewed as a detailed form of system acceptance by the customer.