Design of the Quality Management System for Computer System Validation – Example of Pharmaceutical Industry
DOI:
https://doi.org/10.37886/Keywords:
quality management system, computer system validation, pharmaceutical industryAbstract
Research Question (RQ): What are the basic elements of a QMS for computer systems validation required by European and USA regulation of the pharmaceutical industry.
Purpose: To present a design of a QMS for validation of computer systems in the pharmaceutical industry, which conforms to European and USA regulatory requirements.
Method: The paper first comprehensively shows European and USA legal requirements by using descriptive method and method of comparison. Then we identify the basic elements of a QMS for computer systems validation through the use of method of classification and by using the method of compilation we define them on the basis of comparison of European and USA regulation.
Results: Identification of elements of Quality Management System (QMS) for computer system validation consisting of standard and specific operating procedures. We used pharmaceutical industry as an example, because in order to ensure patient safety pharmaceutical industry is a subject of strict regulatory requirements and highest standards.
Organization: OMS which has been presented represents a basis for practical implementations of computer system validations in a concrete organization.
Society: System presented can provide the basis for all companies in which computer systems play an important role and therefore establishing a quality system for computer system validation is a necessary condition of enabling appropriate management of computer systems.
Originality: We were not able to identify descriptions of elements of QMS for computer system validation within scientific literature.
Limitations/Future Research: Major limitation of the presented system is its design suitable for the pharmaceutical industry, which by its nature is highly regulated. Future work should be both on testing the presented model by using it within the pharmaceutical industry and on analyzing what are the necessary adjustments/simplifications of the presented QMS for industries that are less regulated.
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