IMPLEMENTATION OF CHROMATOGRAPHY DATA SYSTEM IN A QUALITY CONTROL LABORATORY IN THE PHARMACEUTICAL INDUSTRY

Abstract

Chromatography is one of the main analytical techniques, especially in regulated analytical laboratories,
where chromatographic analyses can comprise up to 80% of the total analytical workload. The Chromatography
Data System is computer system with specialized software installed on it, which collects and analyzes
chromatography results from instruments connected to the system. Today, when we operate with electronic records,
the possibility of changing or copying the contents of electronic records, without leaving any visible trace of the
change, is extremely high. To ensure the integrity of the data, the regulatory authorities require the computer
systems validation in accordance with their requirements. The CDS systems are intended for use within regulated
laboratories in pharmaceutical and related industries. The role of these systems in the R&D and QC is within Good
Manufacturing Practice (GMP).
The implementation and validation of CDS systems is carried out to validate key functions of the system and later to
bring the system to end users. Computerized Systems Validation is a process used to test, validate and formally
document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate
manner that is secure, reliable and traceable. This procedure is applied to GxP computerized system applications
used at any point in the research, clinical testing, manufacturing, distribution and storage processes. Examples might
include: Chromatography Data System (CDS), Laboratory Information Management System (LIMS), Laboratory
Instrument Systems (LIS), Clinical Trial Monitoring Systems, PLC for Controlled Packaging Equipment
Supervisory Control and Data Acquisition (SCADA), Distributed Control System (DCS), Enterprise Resource
Planning (ERP) Systems, Manufacturing Execution System (MES), Batch Record System, Building Management
Systems (BMS), Spreadsheets. In the pharmaceutical industry, the most widely used method is to follow the GAMP
5 guidelines and break the process down into its life cycle phases. As a basic starting point for identifying the
process of validating a computerized system, V-model methodology approach to validation is used, which is the
most widespread within the area of computer-based system validation in the pharmaceutical industry. In addition,
there are a lot of supporting processes or activities that take place across the phases of the life cycle such as risk
management, document management, repair activity, security management, etc and you should include them when
visualizing the process