Given the actual influence of the systems on the companies processes and operations with GxP impact, the advance of the technology and its complexity; the implication and commitment of the IT department with the rest of the company, including the quality department, must be high.
The availability of the IT Quality System, the management, security and administration policies, the backup copy etc., are therefore paramount for the correct management of the systems life cycle, the validated system status maintenance and the data integrity.
The regulatory companies must be provided with policies and procedures that allow them to set up every aspect related with the system management:
- Management of the computerized system life cycle, including aspects such as its impact assessment and the criticality of the system (supplier assessment, URS, FS, H&SDS, etc), applicable procedures and policies, maintenance activities, relationship with suppliers, etc
- Company´s policy of physical and logical computer security
- Company´s policy of backup copy and restore; verification of its implementation
- Company´s policy of computerized system validation
- Systems periodical revision
The development and implementation of this policies and procedures must be integrated and in accordance with the global policies and procedures of the company.
Qualipharma has the needed experience to give the support to the companies on policies and procedures identification, its development and integration with the rest of the company areas and systems.
- Deep knowledge about the different company areas and processes affected by the computerized systems implementation
- Deep knowledge about standards, regulations and practices related to the IT systems
- Team experienced on procedures and quality systems integration
- Proved experience on IT Quality Systems