Have you been told, often by your finance department that you must prepare for a new computer system? If so please ensure you raise a change control form and carry out a robust risk assessment . All too often the implementation does not run to plan and the results can be costly in terms of manpower and also loss of business and in the worst case a break in an otherwise flawless supply chain. The validation of computer systems cannot be overlooked.
The computer system validation (CSV) process is used to ensure that all IT applications adequately fulfil their intended purpose. CSV is an important element of the facility’s validation master plan, and all the documentation necessary for equipment must also be prepared for computer system. Most IT systems handle much of the data they handle is relevant to a GMP process, and thus, any failure can have a negative impact on product quality and availability.
As time progresses the complexity of such computer systems increases, resulting in the need for more in-depth validation processes, which need to be backed up by a methodical risk analysis that allows validation efforts to be focused on the most critical aspects of the system. All phases of design, development, testing and the software’s routine use must be controlled throughout the lifecycle of a computerised system if it is to remain properly validated.
GMP demands, specific controls and procedures for the manufacture of Biopharmaceuticals, so beware!
CSV includes every activity involved in the application of appropriate controls and procedures throughout the software development lifecycle, and creating all the documentation required by the MHRA or your competent authority.
If your IT system dovetails into a paper based system then ensure that this is adequately risk assessed and validated. Ensure that the controlled copy is defines accurately. Good Luck.
Written by Jackie Peck