Computer System Validation basically refers to a means of testing and ensuring that computers in a particular organization are working or functioning according to their designated purpose. In organizations like pharmacies or hospitals, computer systems are very important in operations, and therefore will need to be tested and validated on whether they comply with the regulatory requirements of the company as well as government authorities, in terms of development, manufacture as well as the supply of drugs and pharmaceuticals. Some of the things tested are such as clinical practices, laboratory practices, which deal with laboratory operations, manufacturing practices, electronic records or even data management.
When it comes to the Computer system validation course pharmaceutical industry, it is very important to test the computer systems before their use for the safety and quality assurance purposes. The computer-systems compliance will, therefore, mean that the computers will be ready for use in the particular pharmaceutical organization. It is a practice that started back in the United States, where it would involve the standard computer applications, custom as well as the bespoke and the basic functionality of the computer machines. Some of the aspects that would be considered in the systems validation are such as;
System interfaces: This will involve the levels of user accesses from different users, a level of user access for user groups, inputs or outputs to external equipment, as well as the means of communication.
Systems security: This involves the level of the computer security to external intrusions, such as the use of passwords as well as encryption keys.
Normal and abnormal operations: This refers to all the normal functioning of the computers as well as any other kinds of functioning that can be referred to as abnormal, which will involve means of functioning that are away from the normal.
Security of data: The system will be checked for the security of the data kept or stored, as well as the backup and recovery of the data and information.
Points to Consider:
There will be a number of points to consider in the validation of the computer systems for ensuring quality performance of the system such as;
– FDA requirements: This involves good practices such as; Hardware as the equipment within the meaning of CGXP regulations.- Software as records or Standard Operating Procedures (SOPs) within CGXP regulations.
Quality Process: This involves the quality check of the system such as; project planning, SDLC life cycles, project planning, design, programming standards, testing standards, among others.