ASSURANCE OF CHROMATOGRAPHY DATA SYSTEM DATA INTEGRITY THROUGH COMPUTER SYSTEM VALIDATION APPROACH

• Main Author: Wiryani Chandra, Jessica
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/78375
• Institution: Institut Teknologi Bandung

Good documentation is an important part of the quality assurance system and is the key for the pharmaceutical industry to operate according to good manufacturing practice (GMP) requirements. A good documentation system is a quality system that can ensure the accuracy, integrity, availability, and legibility of data and documents which is further known as data integrity. The quality control section of the pharmaceutical industry is one of the most crucial parts in the application of data integrity since the drugs quality is assured through several assays conducted in the laboratory. This study aims to obtain a quality system related to the integrity assurance of the chromatography data system used in the quality control laboratory at PT. ADL Farma. The research was carried out using a computerized system validation approach throughout its life cycle and the V validation model which includes the preparation of user requirements, risk assessment, installation qualifications, operational qualifications, and the preparation of standard procedures related to the quality of the chromatography data system. The results showed that the validation of the chromatography data system used in the laboratory complied with the data integrity requirements and all risks had been mitigated. The standard procedures for assuring the data integrity on instruments and periodic reviews were successfully established, while deviations handling and changes controlling to maintain data integrity of chromatography data systems were improved. It can be concluded that the quality system related to the integrity assurance of the chromatography data system used in the quality control laboratory has been obtained and is ready to be implemented at PT. ADL Farma.