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, ...
CAPAs (or Corrective and Preventive Actions) don’t usually fail at implementation. Instead, they fail because no one checks whether the actions actually solved the problem. In pharma and life sciences, this is more common than it should be.
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 ...
In GxP-compliant environments, the importance of having a skilled and reliable workforce cannot be overstated. Maintaining employee training and competence records is not a choice but a mandate in the highly regulated Life Sciences industry.
Here at Scilife, we understand that QMS implementation and adaption to new technology like an eQMS can raise concerns for many organizations. Questions such as, "Will data import be complex?" "Is the system validated?" or "Will my employees adapt to ...
Ever wondered why some life sciences organizations effortlessly maintain high-quality processes while others struggle to keep up? The secret lies in their adoption of electronic Quality Management Systems (eQMS).
A Complaint Management System (CMS) is a software or procedural framework designed to efficiently handle and monitor customer complaints within a business. It facilitates the submission of complaints through various channels and tracks their progress...