| Practice provides the answer to the remaining | | | | object, but rather an adjective for a property of an |
| questions. Through the variety of and successful | | | | object. |
| validations of computer systems pharmaceutical | | | | The demarcation with qualificationThe terms |
| companies have created accepted procedures for | | | | validation and qualification are very often used |
| the validation of computer systems in a | | | | interchangeably. The precise meaning of and the |
| regulated environment. Over time pointers have | | | | difference between the terms is discussed more in |
| emerged, which are accepted by government | | | | theory than in practical usage. Because a clear |
| agencies and considered standard practice.This | | | | distinction is only possible in theory, the line between |
| document is intended to provide the reader with an | | | | qualification and validation is indeed blurred. However, |
| overview of the issues and topics associated with | | | | as lready shown in practice, a clear distinction is |
| computer system validation in general and specifically | | | | not necessarily required. For completeness the terms |
| in reference to system solutions from METTLER | | | | are explained briefly below. The following definitions |
| TOLEDO. The document shows and describes he | | | | of the terms have been established as a type of |
| steps required in a validation project and helps to | | | | standard. |
| clarify the subject matter. | | | | Hardware and devices are qualified. |
| The steps required for the validation of a | | | | Methods and processes are validated. |
| computer-assisted system can vary from system to | | | | The combination of qualified hardware and validated |
| system. For this reason, the procedure described in | | | | processes and methods results in a validated system. |
| this document must not be considered as the only | | | | Reasons for carrying out validation |
| valid standard.This suggested procedure is intended | | | | Validation in a regulated environment goes beyond |
| as a pointer and must be adapted to customer | | | | simply providing a piece of paper for government |
| requirements in each project. | | | | agencies. The process of validation is complex and |
| The term "validation"The word "validate" is defined in | | | | involves expenditure and effort. But what are the |
| the dictionary as "to make valid", "to legalize" or | | | | reasons for carrying out validation? There are many |
| indeed "to nfirm". But what does this exactly? | | | | reasons, but they tend to have similar origins. The |
| Through validation there is documented evidence that | | | | main and most common reasons are listed below. |
| a process or a system meets the previously | | | | * Obtaining legal compliance for the production of |
| specified requirements in a practical application. | | | | drugs and complementary products. |
| Validation is not a random or precise process. It is a | | | | * Minimizing the risk of malfunction. This can prevent |
| scientific method for confirming the value of a | | | | high costs associated with errors and failure. |
| system for a specific purpose. The use of the word | | | | * Optimizing quality through exact and reproducible |
| in connection with computers originated in the USA. | | | | processes. |
| The term "validation", as used in the USA, refers to | | | | * Obtaining assurance that the system meets the |
| any type of evidence about a state of affairs. | | | | necessary requirements and is therefore suitable for |
| "Validated" is therefore not an adjective for an | | | | production and quality control. |