GAMP 5 (Good Automated Manufacturing Practice) guidelines have been pivotal in establishing industry standards for validating computerized systems in regulated industries like pharmaceuticals, biotechnology, and
This article provides a clear insight into the significance of data integrity within the framework of current good manufacturing practice (CGMP) for pharmaceuticals, as mandated
The pharmaceutical industry is critical in safeguarding public health by researching, developing, and manufacturing life-saving drugs. However, this sector operates in a highly regulated environment
As the Indian pharma sector embraces digitalization and advanced technologies, several key transformations are expected: 1. Global Competitiveness:Â By going digital and incorporating Pharma 4.0, Indian
A long list of data integrity warnings received by pharma companies has made them focus on building and fortifying their tracking mechanisms to prevent things
COVID-19 spurred a sense of urgency in healthcare and pharma professionals, making the entire landscape conducive to change and digital transformation. We are at a
What is GAMP 5? Good Automated Manufacturing Practice, Founded in 1991. International Society for Pharmaceutical Engineering (ISPE) sets the guidelines for manufacturers and the current
Annual Product Quality Review
Electronic
Logbook System
Laboratory Information Management System
Manufacturing Execution System
Calibration & Preventive Maintenance
Regulatory Information Management System
Learning Management System
Environmental Monitoring System
Electronic Quality Management System
User Access Management System
Document Management System
Quality Control
System
Cleaning Validation Software
Process Validation
Software
