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Introduction Define GxP compliance and its importance in the pharmaceutical and biotechnology industries. GxP compliance refers to a set of regulations and guidelines that ensure pharmaceutical, biotechnology, and medical device companies produce safe, effective, and high-quality products. The term “GxP” encompasses various disciplines, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), …

Understanding GxP Compliance: The Role of CSV in Pharma and Biotech Read More »

Computer System Computer hardware components assembled to perform in conjunction with a set of software programs, which are collectively designed to perform a specific function or group of functions. (PIC/S, PI 011-3, 25 September 2007)   Computerized system:- A computer system consists of hardware, software, and network components, together with the controlled functions and associated …

Computerized System Validation Read More »

Now a days everyone is shifting from CSV to CSA, a risk based and more efficient validation approach as compared to generating piles of documents which is un-necessary, only to satisfy regulatory bodies. However regulatory bodies does not want to generate piles of documents for validating computerized system rather than they want companies to have …

Computer Software Assurance: New Way of Computerized System Validation Read More »

Hello Readers,   In today’s fast-paced developing professional world, every individual should be at par with the most required soft skill i.e. management.   Management comes with a huge umbrella ranging from time management, resource management, skill management, etc. All these aspects converge to cover what is commonly called project management.   Project management is …

Basics of Project Management Read More »

Hello Readers,   Hope it was a great weekend. And now as the night grows darker, and the day prepares to change from Sunday to Monday, there’s this little anxiety of the change. Talking of the change, let us now dig a deeper in the change management requirements during project management or in any industry …

Change Management Read More »

The term Industry 4.0 refers to the fourth industrial revolution which brings together rapidly evolving technologies such as the internet of things(IoT),artificial intelligence(AI),robotics, and advanced computing to dramatically change the landscape of manufacturing.   Industry 1.0 Industry 1.0 saw the manual processing of botanical, mineral, and animal derived materials transition from simple hand-operated tools to …

Industry 4.0 & Pharmaceutical Manufacturing : Digital Factory of Next Generation Read More »

Observation We remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts. The current application was released into production on November 9, 2009 using an Interim Validation Report (IVR) that is still not final. Critical issues (deviations) …

Electronic Records – CSV FDA Warning Letters Read More »