In recent years, computerization has been a global trend and the pharmaceutical industry has not been an exception. Under the pressure of improving efficiency and in the face of challenges such as guaranteeing data integrity and traceability of the supply chain, computerisation went from being an incipient to a key element in the pharmaceutical industry.
The benefits of the introduction of computer systems in the pharmaceutical industry are clear. On the one hand, the reduction of manual and paper-based systems, a classic source of errors and less efficient than computer programs. Workflows were also facilitated, improving efficiency. Of course, with the right controls, the safety and quality of the processes was improved.
But it also introduced new challenges. The nature of information systems introduced new risks into the drug substances and drug products manufacturing processes. The ability to manipulate data, the risk of malfunction or wrong decisions taken by the system or the eventual loss of GxP data increases as the systems grew.
Regulatory agencies have not been on the outside of this process. Logically, as computerization became more important, the regulations had to be adapted to this new reality. The appearance of specific regulations such as the FDA’s 21 CFR Part 11 guide or Annex 11 of the GMP, together with the latest Data Integrity guides, only confirm that information technology is already a pillar in inspections and, therefore, an element to be taken care of in suppliers audits. And what the agencies expect from the computer systems is not very different from what they expect from any other critical element: Design Review, initial Risk Analysis and periodic review, Validation and continuous control by the quality system.
In this Webinar we will share our knowledge and experience from having carried out hundreds of audits of APIs, finished products and excipients, in which evaluation of computer systems validation activities use to be a hot topic and should include:
Examples of most common observations will be shown during the webinar and it will be enabled a space for questions and answers.
Technical staff from API, and Pharmaceutical industry.