This article provides guidance on the best practices to adopt when preparing for an audit or inspection, with a particular focus on commissioning and qualification and the points to consider during the development of materials to explain a company’s individual approach to commissioning, qualification, and validation maintenance.
The pharmaceutical industry is undergoing a significant transformation, moving away from traditional paper-based validation processes to adopt digital validation tools (DVTs). This transition began with electronic validation repositories, enabling the digital creation, uploading, and electronic approval of documentation—securely stored and meeting electronic records and signatures compliance...
The pharmaceutical landscape is rapidly evolving, and cell and gene therapies (C>) are at the forefront of this transformation. These therapies are revolutionizing how we approach patient care, particularly in the realm of personalized medicine. However, this innovation has also introduced challenges, especially when establishing new manufacturing facilities.
Paperless Validation is a current topic of interest within the pharmaceutical industry with many companies now adopting or planning to adopt digital solutions with the promise of improved data integrity and more compliant execution of testing activities.
