Automating digital data management in biopharmaceutical manufacturing is a process of using digital technologies such as cloud, artificial intelligence, data lakes, and wearables to collect, store, analyze, and share data across the entire development lifecycle.
Restricted Access Barrier Systems (RABS) have emerged as a cutting-edge technology to address challenges, providing a robust solution for aseptic processing in pharmaceutical and biotechnology industries. In this article, we will delve into what RABS technologies are and explore the steps involved in their successful implementation.
RABS are a type of barrier system that separates the production area from the operator environment by using a rigid machine enclosure, safety-locked doors and ports with gloves.
Keeping health products safe means ensuring that the product lifecycle are implemented and in control. The health product lifecycle here refers to all stages in the pre- and post-market “life” of a health product. According to Health Canada, the stages may include several or all of the following: pre-clinical studies, clinical trials, submission of product
Biopharmaceuticals shall demonstrate at any time their compliance with Data Integrity (DI) requirements. We all know that data Integrity is not a new topic rather, it is an old concept made essential in today’s digital age.