Today, the Quality conversation is no longer about making the digital leap from an outdated paper-based Quality Management System (a traditional QMS) to managing your Quality processes with electronic Quality Management software (an eQMS). That trans...
You’ve probably heard all kinds of advice and guidance for how to implement a Quality Management System. Some helpful. Some overwhelming.
Healthcare faces complex challenges in a world that is becoming more digital day-to-day. It has become clear that healthcare companies will need to embrace open systems that allow for the sophisticated analysis of multiple data streams and the develo...
Nobody knows the importance of 'Quality Records Management' better than a quality assurance professional! Quality records are invariably scrutinized in every internal or external audit. These documents are treated as living evidence of organizational...
Companies in the life sciences continuously strive to adapt to new developments in our rapidly evolving modern world. Professionals in businesses like pharma, medical devices, and biotech know that in this digital age organizing processes and going p...
Rigorous quality management is fundamental in all regulated sectors, including pharmaceutical, biotech and medical device industries. A good Quality Management System (QMS) is able to define and organize documents and other processes in a quality-adh...
What is DMAIC? DMAIC is an acronym for Define, Measure, Analyze, Improve and Control. The DMAIC process is the quality improvement methodology of Six Sigma that’s used for improving existing processes. It is an integral part of a Six Sigma approach, ...
Corrective and Preventive Action (CAPA) management is a vital process of any Quality Management System. CAPAs are the necessary steps that must be taken to eliminate causes of non-conformities or other undesirable situations and lie at the heart of p...
GxP-compliance Software as a Service (SaaS) is becoming increasingly popular owing to its flexibility and ease of use.
In the world we live in today, mass production of goods and industrial development is on the increase and the economy thrives on the capability of countries to export to other countries for profit. These production companies comprise of different dep...
Companies in the life sciences industry need to deal with stacks and stacks of documents. Whether they’re paper or digital, chaos is inevitable if documents are not kept meticulously organized. Document control software is frequently used in the life...
Old habits die hard and a paper-based QMS system is that old habit that has more disadvantages than advantages. Whereas the new eQMS system holds the seeds for success in future regulatory audits. That is why the bad old habit of using a paper-based ...