Software Validation

Continuous Integration

Continuous integration (CI) is a method of integrating changes needed in one single project which is developed, then tested accordingly, this method helps developers to deliver a software in a more efficient and a predictable manner. To understand the importance of continuous integration first we understand how the process is going before continuous integration is […]

Digital Transformation

Innovative Solutioning Strategy around enterprise applications

What is an enterprise application? The software solution used across departments of an enterprise to improve overall efficiency, effectiveness and productivity of various functions. Such system normally works on single, undisputed source of master data; and modules exhibit usage in multiple departments with interdependency over one-another. What is a successful enterprise application deployment? Those who […]

Digital Transformation

Digital Transformation Strategies in Clinical Research: People

Continuing the discussion about digital transformation strategies in clinical research, the People angle, which would be the most critical angle. Like any other business process reengineering, it is people who will make it success or failure. It is more important in digital transformation, because in effort to make people more powerful and effective, and, empower […]

Software Validation

CSV and Documentation

Each regulated record (is a GMP record) and should be periodically reviewed Strong SOP and Work instructions repository covering all working areas Templates for all documentation, processes – recommended, mandatory VMP for computer systems – mandatory for all who are regulatory audited and use the same for validation across for computer systems URS – always […]

Software Validation

Significance of CSV in Life Science Industries & How is CSV approach related to SDLC?

Computer System Validation (CSV) is the practice of ensuring that any software or hardware which meets its purpose with regulatory guidelines. The pharmaceutical business model is emerging, and CSV is becoming even more crucial because of the increasing scope of information systems, more integrated functionality, consolidation, and archiving requirements. It helps companies to maintain its […]