Definition of the term (“What does validation mean?”)
Validation plays a special role in all regulations of the GxP environment. Fundamentally, the validation means providing a documented proof that a certain process continuously produces a product that fulfills the previously defined specifications and quality characteristics. This is done to prevent any risk for human beings arising from the production process of quality assurance process. This especially affects the medical technology and the pharmaceutical industry.
What does software validation mean?
In this context, the GMP guidelines specify that the computer systems or software supporting the development or production of products of the above mentioned industries must also be validated. The software must be able to access the desired results exactly, continuously and reproducibly at all times. The FDA mentions the validation of software as a confirmation resulting from checks and the provision of objective evidence that the software specification complies with user requirements and the intended use and that the requirements are consistently met.
What does medical validation mean?
The medical validation describes the determination of the validity of the test results in relation to the research question and represents the release of a laboratory result to the contracting entity
by a specialist.
Why is validation important?
The validation should respond to the questions, if the software is adequate for the intended use, if it provides the required functions, and if it is sufficiently reliable and efficient. Computer-based systems play a central role when producing and validating pharmaceutical or medicinal products. This explains why the systems must be validated from a GMP point of view.
In addition, validation provides documented proof that it is possible to create reproducibility. In other words, a company is capable of producing the same end product under the same conditions.
What is the difference between a user requirement specification and a functional specification?
The user requirement specification describes in concrete form how the contractor intends to meet the requirements of the contracting entity. However, the entire claim is first described as precisely as possible by the contracting entity in the user requirement specification.
Advantages of validations?
- Increasing the understanding and traceability of processes (systems, data, change management, …)
- Increased user confidence in the computer-based system
- Increased care in handling data and documents
- Increase of data security by means of controlled systems
- Increase of work efficiency by means of tested and secured processes
What role does risk management play in this?
Risk management is an important basis of quality management which should also be applied to the validation in the various forms and phases. This results in numerous quality-relevant and comprehensible decisions, which must also be documented and proven and which are included in the validation approach.