GLP and digital transformation
The use of computer-aided systems in technologically well-equipped, competent laboratories is indispensable. Since this is now part of the laboratory processes, the safety, accuracy and traceability of electronic data must be checked. These are important points in the context of the GLP (good laboratory practice), and we can tell from the OECD published GLP consensus document No. 10 learn how to implement these points.
The application of the GLP principles to computer systems includes all types of computerized systems used in GLP works. These include:
- Data Collection and Analysis Systems
- Laboratory Information Management Systems (LIMS)
- Automatic control software
- Electronic archiving systems
These computer-aided systems must have appropriate design and sufficient capacity, have defined appropriate control and maintenance procedures, and have been developed and validated in accordance with GLP principles.
Aspects to consider when applying GLP principles to computerized systems
1. Responsibilities: In order to ensure compliance with GLP principles, the responsibilities in the document are listed as follows: management responsibilities, labor manager responsibilities, laboratory personnel responsibilities and quality assurance body responsibilities.
In short, the management is responsible for the proper development, validation and operation of the computer system, and that Data Processing Policy and Procedures are defined.
The work manager must ensure that the work performed under the GLP is managed and that validated systems are used. In this context, the laboratory staff is responsible for operating the system in accordance with the GLP Principles.
The tasks of the quality assurance unit must be clearly defined in written guidelines and procedures. This includes system validation, operational processes, maintenance measures and the evaluation of acquired and internally developed systems.
2. System Validation: Every computer-aided system must be validated and documented according to its intended use. Validation ensures that the system works correctly and consistently.
3. Authorization and Access Control: It must be ensured that only authorized persons can access the system; User identities, password management, and role-based access controls must be implemented.
4. Data integrity and security: Data must be indelible, unchangeable and logged. An audit trail must be used, every process must be comprehensible.
5. Change control: Any change to the system must be logged and, if necessary, validated again. This also applies to software updates.
6. System Backup and Recovery: All data must be backed up regularly and recoverable if necessary. The security procedures must be specified in writing.
7. System support and maintenance: The system manufacturer or the internal IT department is responsible for maintenance, repair and technical support. All operations must be logged.
8. Training and Responsibilities: The staff using the system must be trained in relation to GLP and the system-related procedures. The responsibilities must be clearly defined according to the roles.
9. Documentation Requirements: All documents such as user manuals, procedures, validation reports and training documents must be systematically archived.
10. Cooperation with external service providers (outsourcing): If system services are purchased from third parties (e.g. cloud services), their GLP compliance must also be documented and contractually defined.