Approach for validating computerized systems in the context of artificial intelligence and machine learning involves a comprehensive and...

Drug development is a billion-dollar industry featuring a variety of roles necessary to pursue the goal of product approval. A crucial...

Herbal medicines, known as phytomedicines or botanical medicines (Phyto- Plant) contains plant parts like, leaves, roots, stem,...

Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees...

Become a certified Medical writer from best Institute in India Changing market dynamics, expiring patents, and depleted product pipelines...

Get Best training and certification in Pharmacovigilance The History of Pharmacovigilance roots back to the rise in awareness among...

Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") is the process of...

Developing a new drug from original idea to the launch of a finished product is a complex process which can take 12–15 years and cost in...

coClinical data management leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps...

Knowing What Pharmacovigilance is? According to WHO Pharmacovigilance is the science and activities relating to the detection,...

The Purpose of this Blog is to Provide guidance for the industry on the key concepts of Computer Software Assurance and provide direction...

Observation 1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized...

Hybrid Systems (Deleting Electronic Data) In Hybrid systems the computerized system is used to generate a record which is printed and...

Observation 1. Your firm has not established and documented the accuracy, reliability and performance of your computer systems employed...

Observation Failure to maintain a written record and appropriate validation data of computer or other automated processes used to perform...

Observation We remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have...

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,...

Hello Readers, In today's fast-paced developing professional world, every individual should be at par with the most required soft skill...

Computer System Computer hardware components assembled to perform in conjunction with a set of software programs, which are collectively...

Category of software Application are categorized into following software categories as per GAMP 5 guideline 1. Category 1 –...